Ob/Gyn & Women’s Health Perspectives - Cleveland Clinic ... · This issue of Ob/Gyn & Women’s Health Perspectives highlights several examples ... clevelandclinic.org/obgyn | 800.553.5056

Ob/Gyn & Women’s Health PerspectivesAn Update for Physicians from Cleveland Clinic’s Ob/Gyn & Women’s Health Institute

Winter 2010

Innovative Procedure Addresses Cancer of the Peritoneal Cavityp 6

AlsO In tHIs IssUe

Fetal Care Center teams

Up to treat Infant with

eye Anomaly

p 8

Gyn Office

Procedures expand

p 4

Gynecologic Oncologist

earns Prestigious Award

in China

p 11

trial Compares

traditional and Robotic

sacrocolpopexy

p 12

72222_CCFBCH_ACG.indd 1 11/15/10 2:40 PM

CONTENTS

3 Clinicians and Scientists Collaborate on Promising Breast Cancer Research

4 Gyn Office Procedures Expand

6 Innovative Procedure Addresses Cancer of the Peritoneal Cavity

7 Increased Education Required to Improve Maternal Influenza Vaccination

8 Fetal Care Center Teams Up to Treat Infant with Eye Anomaly

11 Cleveland Clinic Medical Students and Staff Provide Care in Peru

10 Gynecologic Oncologist Earns Prestigious Award in China

12 Trial Compares Traditional and Robotic-Assisted Laparoscopic Sacrocolpopexy

13 Selected Publications

Dear Colleagues & Friends:

This is an exciting time for Cleveland Clinic’s Ob/Gyn & Women’s Health Institute. Our commitment to clinical excellence, innovation, education and research has earned us recognition as the No. 4 program in the country, according to U.S.News & World Report. We are proud and humbled by the confidence our patients and colleagues have shown in our treatment of women, but we are not resting on our laurels. We continue to explore new approaches to obstetric and gynecologic care that will improve our outcomes.

While our main campus location has long been a national referral center for ob/gyn care, we are expanding throughout Northeast Ohio in regional hospitals and family health centers, bringing specialized care closer to home for our patients. Whether patients are referred from near or far, we work closely with their primary ob/gyn, offering treatment recommendations and follow-up care to the extent desired.

This issue of Ob/Gyn & Women’s Health Perspectives highlights several examples of our innovative work. Among the advancements featured in the following pages area promising approach to cancer of the peritoneal cavity, exciting progress toward developing a breast cancer vaccine, development of a robust menu of hysteroscopic office procedures and research that will help define the role of robotics. I also am pleased to share the work of our team members who are actively involved in interna-tional humanitarian efforts

For more information on our work, please take a look at the recently released edition of our Outcomes book, available online at clevelandclinic.org/quality/outcomes.

I hope you find this edition of Ob/Gyn & Women’s Health Perspectives valuable. I look forward to continued collaboration with you. As always, I welcome your comments and feedback.

Sincerely,

Tommaso Falcone, MD Professor & Chairman, Department of Obstetrics and Gynecology Chairman, Ob/Gyn & Women’s Health Institute

Cleveland Clinic’s gynecology program is ranked No. 4 in the nation by U.S.News & World Report.


3

Clinicians and Scientists Collaborate on Promising Breast Cancer Research

For more than 30 years, the search for an effective breast cancer vaccine has eluded scientists throughout the world.

However, a Cleveland Clinic researcher recently reported the development of a vaccine that provides safe and effective

protection against the growth of breast tumors in mouse models. Remarkably, this protection occurs in the complete

absence of any detectable side effects.

Scientists in the laboratory of Vincent Tuohy, PhD,

Department of Immunology in the Lerner Research Institute,

evaluated alpha-lactalbumin, a breast-specific protein

over-expressed in the majority of human breast tumors

but expressed only during lactation in the normal breast.

The research involved vaccination of mice with recombi-

nant mouse alpha-lactalbumin. The team then assessed

responses in normal mice and in several mouse breast

tumor models, including autochthonous tumors in

MMTV-neu and MMTV-PyVT transgenic mice, as well as

transplantable 4T1 tumors in BALB/c mice. The data show

a significant treatment effect when mice with established

breast tumors are vaccinated and also show a highly signifi-

cant inhibition of tumor growth when vaccination occurs

prior to the appearance of palpable autochthonous tumors

and prior to inoculation of 4T1 breast tumors.

“We are hopeful that this vaccine strategy will someday be

used to prevent breast cancer in adult women in the same

way that vaccines prevent polio and measles in children,”

Dr. Tuohy says.

Derek Raghavan, MD, PhD, Chairman of Taussig Cancer

Institute, expressed cautious optimism over Dr. Tuohy’s

findings.

“This work is intriguing and the science is impressive,” says

Dr. Raghavan. “If Dr. Tuohy’s early research is validated in

clinical studies, it could potentially reduce the incidence

of breast cancer. We’re currently designing trials here at

Cleveland Clinic to test the vaccine in humans, but we’re

five to 10 years away from being able to offer it to women.”

Financial support is now needed to continue the processes

involved in moving this from the lab to the research venue to

the patient. ◆

Dr. tuohy’s research is published in Nature Medicine, June 2010, “A prophylactic, autoimmune-mediated vaccination strategy for breast cancer,” and can be found at www.nature.com/nm/index.html.

3clevelandclinic.org /obgyn | 800.553.5056


Gyn Office Procedures Expand:

Recent research has confirmed that hysteroscopic

procedures such as sterilization and endometrial ablation

performed in an office setting are safe, efficient and

provide a high degree of patient satisfaction. With patient

demand increasing for these services, gynecologists

should be aware of important requirements that will

enable them to provide office hysteroscopic procedures.

In the November 2008 edition of Journal of Reproductive

Medicine, “Utility of in-office endometrial ablation: a pro-

spective cohort study of endometrial ablation under local

anesthesia” concluded that endometrial ablation can be

performed successfully in a physician’s office under local

anesthesia and oral anixolysis with low patient pain scores,

high tolerability and high patient satisfaction. The study

found 130 of 143 patients reported being very satisfied with

the office procedure, while 13 patients said they were satisfied.

Cleveland Clinic gynecologists have found no clear advan-

tage to performing hysteroscopic sterilization in a hospital

operating room versus performing the procedure in a physi-

cian’s office.

Patient satisfaction, safety and efficiency drive demand for office hysteroscopic procedures

CLEVELAND CLINIC OB/GyN & WOMEN’S HEALTH PERSPECTIVES | WINTER 20104


strong Demand

“Office endometrial ablation is very much in demand, and

hysteroscopic sterilization is growing in popularity as more

patients become aware of the common benefits of this

minimally invasive procedure,” says Cleveland Clinic ob/gyn

Jonathan Emery, MD. “Because demand for these services

is growing, it is recommended that gynecologists consider

certain steps that will help them establish safe and efficient

office hysteroscopic procedures for their patients.”

Dr. Emery is among several gynecologists who perform outpa-

tient hysteroscopic procedures at Cleveland Clinic locations

throughout Northeast Ohio.

To develop the necessary technical proficiencies, Dr. Emery

recommends that physicians perform at least 10 to 20 hystero-

scopic procedures in a hospital operating room.

“I also recommend a minimal amount of proctoring to guide

physicians through their first few cases in the office setting,

which can enhance their comfort and confidence level when

they begin to perform these procedures solo,” Dr. Emery

explains. “Moreover, the companies that offer outpatient

sterilization methods require some degree of proctoring

for physicians.”

new Methods

Two sterilization methods that can be used in a physician’s

office are Adiana and Essure. Adiana is a new hysteroscopic

sterilization procedure that was approved for use by the U.S.

Food and Drug Administration last year. This method utilizes

radio frequency energy and a polymer microinsert that

together result in tubal occlusion in the interstitial segment

of the fallopian tube. Essure sterilization, which has been

in use since 2002, is a coiled spring device that is inserted

through the uterine cavity into the tubal opening utilizing

a hysteroscope.

“These companies provide simulation training for physicians

so they can develop a thorough understanding about how

the methods work,” says Dr. Emery. “Following this training,

companies also encourage physicians to have a proctor to

guide them through the steps of one or two procedures in an

office setting.”

Newer methods of endometrial ablation enable gynecolo-

gists to perform the procedure without special training. The

methods utilize radiofrequency, freezing, heated fluid, heated

balloon or microwave energy.

“These global methods treat the whole lining of the uterus,

which theoretically provides a more uniform destruction of

the endometrial lining,” explains Dr. Emery. “These methods

are straightforward and have safety mechanisms, although

they are not without risks. However, if physicians follow the

prescribed recommendations and safety procedures, the

outcomes are positive in terms of decreasing the patient’s

menstrual cycle."

necessary Protocols

In addition to obtaining the necessary medical equipment

such as a hysteroscope, fluid management system and other

surgical tools, performing office hysteroscopic procedures

requires protocols that typically involve a paracervial block,

non-steroidal pain relievers and, in some cases, anti-anxiety

medications.

“It also is important to have a well-trained office staff. You

need a nurse or a medical assistant who can assist from the

technical side and from the patient management side,” says

Dr. Emery. “Although these procedures require only a local

anesthetic and medications for pain management during and

after the surgery, it may be helpful to train your staff to utilize

‘vocal local techniques’ to engage and distract the patient in

conversation, which can help lower anxiety.”

Patient selection Critical

“Not all patients are suitable candidates for an office hystero-

scopic procedure,” explains Dr. Emery. “For example, a patient

who can barely withstand a physical examination is clearly

not ideal. Of course, qualifying a patient also requires a com-

prehensive review of her medical history, including whether

she has had a C-sections or other prior surgeries or has an

unusual uterine anatomy that may make the procedure too

complex to perform in a physician’s office.”

In these cases, performing hysteroscopic procedures may be

more appropriate in a hospital operating room. ◆

to refer a patient to Dr. emery or to discuss office procedures, call 440.943.2500 or email [email protected].



Innovative Procedure Addresses Cancer of the Peritoneal Cavity

Cancer of the peritoneal cavity that originates from

primary colorectal cancer, ovarian cancer, gastric

cancer, appendiceal cancer, mesothelioma and

peritoneal carcinomatosis has been virtually incurable.

For patients diagnosed with Stage IV peritoneal

carcinomatosis, survival is approximately four months.

Surgical therapy is producing promising results for some

patients. Cytoreductive (debulking) Surgery (CS) and

Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

are aggressive treatments that have been shown to increase

life expectancy for well-selected patients with advanced

abdominal cancers.

“Recently, a series of research studies has shown clear benefits

for patients who have undergone CS and HIPEC surgeries,”

says Cleveland Clinic hepato-pancreato-biliary and transplant

surgeon Sricharan Chalikonda, MD, who performs approxi-

mately four CS and HIPEC surgeries every month. “For the

right patients, we are starting to see survival rates increase

by years.”

CS is a complicated surgical procedure that takes up to 10 to

12 hours to perform. It involves the destruction and/or resec-

tion of visible tumors within the peritoneal cavity. Depending

on the size and location of the tumors, the procedure also

may involve the partial resection of various viscera, such as

the small bowel, large bowel, spleen and uterus.

Removing all visible tumors is crucial to the patient’s progno-

sis for long-term survival. The patient’s survival also depends

on the volume of tumors within the abdomen and the aggres-

siveness of the carcinoma. The patient’s survival outlook

decreases when all tumors cannot be eradicated or resected,

unless they are less than 2.5 millimeters.

HIPEC facilitates the destruction of very small tumors that

cannot be seen by the surgeon. HIPEC also eliminates cancer

cells that may be hiding or those that may have been released

during resections of visible tumors or when portions of

visceral organs have been removed. The HIPEC procedure

involves placing special catheters in the patient’s abdomen.

Once the chemotherapy agent is heated to 42 degrees Celsius,

it is distributed into the abdomen through the catheters for

100 minutes.

“HIPEC enables us to deliver higher concentrations of the

chemotherapy agent into the peritoneal cavity, which facili-

tates the destruction of remaining cancer cells,” explains

Cleveland Clinic gynecologic oncologist Pedro Escobar, MD,

Director of Robotic and Minimally Invasive Surgery, who

operates with Dr. Chalikonda on gyn cases.

HIPEC causes fewer side effects than IV chemotherapy

because of the peritoneal plasma barrier, which prevents

the high concentrations of the chemotherapy solution from

invading the bloodstream.

Patients who may be candidates for CS and HIPEC are those

with Stage IV cancer that is confined to the abdomen with no

evidence of hematagenous spread of the disease. Other fac-

tors include comorbidities, the type of cancer, surgical history

and the patient’s overall physical strength to withstand the

CS and HIPEC procedures. ◆

To make a referral or for more information, please contact Dr. Escobar at 216.445.8486 or Dr. Chalikonda at 216.445.0053.

Cover story

6 CleVeland ClInIC Ob/Gyn & WOmen’S HealtH PerSPeCtIVeS | WInter 2010

72222_CCFBCH_ACG.indd 6 11/22/10 10:28 AM

In February 2010, Cleveland Clinic launched a study of vac-

cination compliance in pregnant women who received their

prenatal care in Cleveland Clinic outpatient clinics and

planned to receive intrapartum care at Hillcrest Hospital, a

busy (3600 deliveries per year) community hospital located

in the eastern suburbs of Cleveland. Patients were asked to

answer 18 questions while waiting for an office visit during

the month of February. The questionnaire involved both

seasonal and H1N1 vaccination. Descriptive statistics were

applied, and comparisons were made using appropriate tests.

A total of 328 questionnaires were collected at a gestational

age of 23.5 weeks.

The study indicated that the major reason for refusal of both

the seasonal and H1N1 vaccination was belief that the vac-

cines had not been studied enough. Despite reports from a

recent review of the safety of the inactivated influenza vaccine

verifying that no study has yet demonstrated an increased risk

of either maternal complications or adverse fetal outcomes,

the issue of vaccine safety remains an important barrier.

The next most frequent reason for refusal was related to the

fact that the patient’s ob/gyn provider neither discussed nor

recommended vaccination. When the ob/gyn provider dis-

cussed H1N1 vaccination, 69.1 percent of the patients received

the vaccination, compared to 33.3 percent who declined the

H1N1 vaccination (p<0.001). When the patient either strongly

agreed or agreed that the ob/gyn provider thought it was

important to get vaccinated against H1N1, the vaccination

rate increased from 34.2 percent to 75.7 percent (p<0.001).

When the ob/gyn provider did not recommend seasonal

vaccination, 92.7 percent refused vaccination, compared to

40.8 percent who refused when it was recommended by the

ob/gyn provider (p<0.001).

Increased Education Required to Improve Maternal Influenza vaccination

By elliot Philipson, MD, Jonathan emery, MD, and Benjamin nutter

While pregnant women represent just 1 percent of the U.S. population, they accounted for 5 percent of H1N1 flu

deaths in 2009, according to a study by the Centers for Disease Control and Prevention. H1N1 is about as deadly

as seasonal flu overall, but kills a higher proportion of those who are otherwise young and healthy, and is more deadly

for pregnant women.

The three factors that produced the highest vaccination rate

were having a discussion with the ob/gyn provider, the pro-

vider's recommendation, and the belief that the vaccine had

been studied enough.

It is clear from this study that to increase the vaccination

rate of both seasonal and H1N1 influenza during pregnancy,

there must be improvement in the information provided by

the obstetrical providers to their patients. In a climate where

more than 75 percent of the patients either strongly agreed

or agreed that the advice by their providers was important to

them, almost 30 percent reported that their ob/gyn providers

did not discuss influenza or vaccination with them.

More information and educational materials that are directed

to both patients and providers addressing barriers to vaccina-

tion should be considered. This type of interventional strategy

would improve antepartum care, have economic value and,

most important, decrease the severity of H1N1 influenza and

maternal deaths in this high-risk group. ◆

Drs. Philipson and emery recently presented their results at the annual meeting of the Central Association of Obstetricians and Gynecologists. For more information on the study, contact Dr. Philipson at 440.312.7774 or [email protected] or Dr. emery at 440.943.2500 or [email protected].



Fetal Care Center Teams Up to Treat Infant with Eye Anomaly

When a maternal or fetal problem threatens a pregnancy, Cleveland Clinic’s Fetal Care Center facilitates diagnosis,

offers counseling, and orchestrates delivery and immediate postnatal treatment to maximize patient outcomes.

Team members shift to meet the needs of each clinical

situation. In the following case, the center’s maternal-fetal

medicine specialists and neonatologists teamed with an

ophthalmic oncologist, ophthalmic geneticist, pediatric neu-

rosurgeon and fetal imaging specialist when an orbital cyst

was diagnosed in utero. The entire process was coordinated

by one of the center’s two advanced practice nurses, who also

provide constant communication and support to the family.

History: An ultrasound for an unrelated obstetric concern

revealed an orbital cyst in the fetus (at 27 weeks, 6 days esti-

mated gestational age) of a 28-year-old, G2P0 woman. The

4-cm x 2-cm cyst behind the right eye occupied the right orbit,

with a high likelihood of extensive damage within the eye.

The left orbit appeared normal. The mother and father were

advised of concerns about fetal brain development, although

ultrasound findings appeared normal. Upon hearing this, they

sought a second opinion in Cleveland Clinic’s Fetal Care Center.

Maternal-fetal medicine consult: The couple met the following

day, Sept. 17, 2008, with maternal-fetal medicine specialist

Jeffrey Chapa, MD, for a repeat ultrasound and consultation.

Imaging revealed the cystic mass posterior to the right eye;

however, the globe, including the lens and muscular attach-

ments, appeared to be intact. The eye was severely proptotic,

protruding from the orbit.

Cesarean section was planned to avoid potential trauma to

the globe during passage through the birth canal. Left eye

findings were unremarkable, as were intracranial anatomy

and the remaining fetal anatomy.

Fetal MRI: Ultrafast fetal MRI, obtained the following day in

our Fetal Imaging Center, showed an intraconal cyst involving

the right orbit that produced marked proptosis but minimal

globe deformity. Pediatric imaging specialists Janet Reid, MD,

and Stuart Morrison, MD, believed that location and appear-

ance suggested a lymphatic or venolymphatic malformation

or, less likely, a colobomatous cyst. Because the finding was

relatively recent, concerns were raised regarding rapid pro-

gression of the cystic structure. Follow-up MRI was planned

in two weeks.

Ophthalmology consult: After a follow-up visit with Dr. Chapa,

the couple had a prenatal consult on Sept. 23 with Arun Singh,

MD, Director of Ophthalmic Oncology in Cleveland Clinic’s

Ultrafast fetal MRI revealed intraconal cyst involving the right orbit, producing marked proptosis

Several stitches placed to protect what appeared to be the functional globe

Baby at 6 months of age growing and thriving

8 Cleveland CliniC Ob/Gyn & WOmen’s HealtH PersPeCtives | Winter 2010


Ashtabula County

Medical Center

2420 Lake Ave.

Ashtabula, OH 44004

440.997.6915

Beachwood Family Health

and surgery Center

26900 Cedar Road,

Suite 210 South

Beachwood, OH 44122

216.839.3100

elyria Family Health

and surgery Center

303 Chestnut

Commons Drive

Elyria, OH 44035

440.204.7400

Fairview Medical Center

18099 Lorain Ave.,

Suites 320/345

Cleveland, OH 44111

216.476.7144

Hillcrest Medical Office

6770 Mayfield Road,

Suite 426

Mayfield Heights, OH

44124

440.312.2229 (BABy)

Independence Family

Health Center

5001 Rockside Road,

Crown Center II

Independence, OH 44131

216.986.4130

lakewood Hospital

Community Health Center

1450 Belle Ave., Suite 310

Lakewood, OH 44107

216.529.2202

Westlake Medical Campus

850 Columbia Road,

Suite 320

Westlake, OH 44145

216.476.7144

strongsville Family Health

and surgery Center

16761 SouthPark Center

Strongsville, OH 44136

440.878.2500

Wooster Family

Health Center

1740 Cleveland Road

Wooster, OH 44691

330.287.4930

Expanded Maternal-Fetal Medicine Services

Cleveland Clinic has expert maternal-fetal medicine

services in several locations in Northeast Ohio.

Our high-risk pregnancy-related services include

preconception planning, pregnancy management

(primary or consultative) and delivery. Our goal is to

get patients in to be seen in a timely manner, while

keeping them close to home.

Cole Eye Institute. Dr. Singh discussed the ultrasound and

fetal MRI findings with them, describing potential diagnoses

and treatments for the orbital mass, based on the findings at

birth. The repeat fetal MRI on Sept. 30 showed relatively little

change, and surveillance continued via ultrasound for the

remainder of the pregnancy.

Orchestrating delivery: The Cesarean section was scheduled

for Dec. 1, 2008. Standing by were Dr. Chapa and maternal-

fetal medicine colleagues (to facilitate care for the mother)

and neonatologists Ricardo Rodriguez, MD, and Sabine Iben,

MD (to care for the newborn). Dr. Singh and his ophthalmic

surgical team, ophthalmic geneticist Elias Traboulsi, MD,

and pediatric neurosurgeon Mark Luciano, MD, were ready.

Side-by-side operating rooms were reserved. The father was

present for delivery, and the baby was promptly assessed.

The father then carried his daughter to the adjoining OR for

further assessment.

Prompt team assessment: Drs. Singh, Traboulsi and Luciano

were concerned that the proptosis worsened when the baby

cried. They quickly decided that further imaging was needed

to determine the cyst’s possible etiology prior to any invasive

procedure. Dr. Singh placed several stitches (a temporary

tarsorrhaphy) to protect what appeared to be the functional

left globe.

surgery and follow-up: Imaging revealed that the cyst had no

communication with any intracranial structures. Under the

care of Drs. Singh and Traboulsi, the baby underwent two

surgeries for partial cyst removal, with histopathologic con-

firmation of a benign squamous epithelial cyst.

By the time the baby reached 6 months of age, she was growing

and thriving. The cyst had not recurred, and she had good use

and function of her right eye. She required continued follow-

up to check for cyst recurrence and would likely need surgery,

including a procedure to shorten her right extra-ocular

muscles and cosmetic surgery for her eyelids. ◆

to refer families to Cleveland Clinic’s Fetal Care Center, please call coordinator Donna Patno, Rn, CnM, DnP, at 216.444.9706 or 866.864.0430.



Cleveland Clinic Medical Students and Staff Provide Care in Peru

CCLCM students Anna Brady, Jacqueline Chu, Alida Gertz,

Rachel Roth and Satoko Kanahara initiated the project.

They were accompanied by Tommaso Falcone, MD, Chairman,

Ob/Gyn & Women’s Health Institute, and retired staff member

Gita Gidwani, MD, as well as professionals from around

the country, including students and physicians from Yale,

Dartmouth, Mayo Clinic and Stanford.

The group was invited by the mayor and a local nonprofit

organization, Peruvian Hearts, to help the clinic become a

trusted and sustainable entity in the community. As team

members helped the clinic, they also soaked up many real-

life lessons.

“The level of teaching for the fourth-year students has been

great − we see patients on our own, present them with an

assessment and plan, have one of the doctors look over the

physical/history, and do some one-on-one teaching. Everyone

agrees they are learning a lot,” Roth wrote in her blog.

Participants saw the true value of simple human contact.

“Listening and reassuring them or directing them within the

medical system is the most important part of the medicine

we do here, and, indeed, medicine in general ... and (it) can

do as much for their state of mind as temporary fixes like

albendazole or Tylenol,” she wrote.

Kathleen Franco, Associate Dean of Admissions and Student

Affairs at CCLCM, says the faculty is very proud of the stu-

dents. “We are thrilled about what they did there and how

much of their free time they spent beforehand making sure it

went well,” she says.

Their preparation took place over about a year and a half

and included taking Spanish classes every Sunday, as well

as jumping legal hurdles and acquiring support, supplies

and advisers.

“They believed in it enough to make it happen,” Dr. Franco

says. “They were extremely respectful and concerned for those

who do not have the healthcare we receive in this country.”

Student Shares Snapshot

While the clinic was clean and spacious, it lacked some

key details. For example, it has a lead-lined room for X-rays

but no X-ray machine, and an operating room but no lights

or equipment.

Roth says the team expected a slow start the day it arrived

because local radio stations announced they were coming a

day later, but those expectations were soon cast aside. “We

were planning on getting organized in the morning and

starting to accept patients at 1 p.m. By 8:45 a.m., there was a

line,” Roth wrote in her blog. “As we watched people trickle in

steadily, it became obvious that the longer we waited to see

people, the longer we would be at the clinic.

“By 9:15, I was taking stitches out of a woman whose bull had

impaled her. It was only her leg, but there was an entry wound

and exit wound, and it was infected and ulcerated of course,

and why are the stitches still in three weeks later? Plus, do you

have any idea of the kind of logistics necessary to treat even

the smallest thing? First, just a place to sit. She sat in a spare

dentistry chair. I squatted on the floor. Second, light. We left

the door open for the hallway light, and I used my penlight

to spot the stitches amongst the scab and the healing tissue.

Third, water. Even if it was running somewhere in the clinic,

it’s not clean, so I used lots of iodine and alcohol ... she took

45 minutes. There were 10 people in the waiting room when I

came out at 10 a.m.”

A group of students and staff from Cleveland Clinic Lerner College of Medicine traveled to Peru’s impoverished area

of Lamay in the summer to staff a clinic established by the town’s mayor to attract medical personnel.

10 CLeveLAnd CLiniC Ob/Gyn & WOMen’s HeALtH PersPeCtives | Winter 2010


The team adjusted quickly, though, and two days later

saw about 80 patients in the same amount of time that

40 were seen the day before.

Future Directions

Surprised by the number of domestic violence prob-

lems it saw, the team initiated plans for a women’s

health clinic and domestic violence shelter, as none

in the region allows women to stay with their children.

(The children are sent to orphanages.) The mayor is

developing a rehabilitation and education program for

alcoholics to complement this effort. The team hopes

to repeat the trip annually for Cleveland Clinic and

Case Western Reserve University students as an elective

clinical rotation. ◆

To learn more, visit http://www.lamayclinic.org/ or email [email protected].

Gynecologic Oncologist Earns Prestigious Award in China

Jerome L. Belinson, MD, professor of surgery

in Cleveland Clinic Lerner College of Medicine

and founding director of Preventive Oncology

International, recently received the esteemed

Friendship Award from the People’s Republic

of China. Chinese Vice Premier Zhang Dejiang

recognized Dr. Belinson in a ceremony during this

year’s National Day celebrations in Beijing.

The Friendship Award, established in 1991, is China’s

highest award given to a foreign expert who has made

outstanding contributions to China’s economic and

social progress.

For more than 14 years, Dr. Belinson has worked to

bring gynecologic cancer screening integrated with

clinical trials to rural China, an area of the world with

a high prevalence of female cancers. Through his efforts

and the work of his POI colleagues, almost 40,000

women who participated in the studies received screen-

ing for cervical cancer, often for the only time in their

lives. Dr. Belinson and his team have been recognized

for their careful adherence to human values and the

proper conduct of studies involving human subjects in

the Third World.

“After more than 30 years in the full-time practice of

gynecologic oncology, my work in China has been the

highlight of my professional life,” said Dr. Belinson.

“Our mission is far from done, and it is my sincere hope

that this award will draw attention to the continuing

need for support for our efforts.” ◆

clevelandclinic.org /obgyn | 800.553.5056 11


Trial Compares Traditional and Robotic-Assisted Laparoscopic Sacrocolpopexy

Cleveland Clinic Director of Urogynecology and Reconstructive Pelvic Surgery Marie Fidela Paraiso, MD, recently

reported results from the first randomized clinical trial comparing traditional laparoscopic sacrocolpopexy to robotic-

assisted laparoscopic sacrocolpopexy. The study was the largest randomized controlled study comparing the two surgical

approaches in any field to date. While the primary outcome measured was operating time from incision to closure, the

trial also addressed other operative parameters, anatomic, functional and quality-of-life outcomes.

Dr. Paraiso’s team enrolled 76 patients, 67 of whom were

randomized and underwent surgery (32 traditional, 35

robotic-assisted). Inclusion criteria included post-hysterec-

tomy vaginal apex prolapse at POPQ stages 2-4; age over 21

years; and a desire for laparoscopic surgical management.

Patients were excluded based on contraindication for general

anesthesia; history of prior sacrocolpopexy; suspicious

adnexal masses or other factors that could increase risk of

pelvic malignancy; history of pelvic inflammatory disease;

morbid obesity (BMI over 40); or history of prior or concomi-

tant need of rectopexy for rectal prolapse. There were no

differences in demographic and preoperative anatomic and

functional data between groups.

Surgical experience (analyzed per surgeon) showed that there

was no significant association between the number of cases a

surgeon performed and any of the surgical times recorded.

“Both approaches led to significant improvement in anatomic

outcome and pelvic floor function at six months,” says Dr.

Paraiso, an internationally recognized pioneer in laparo-

scopic sacrocolpopexy. “We found no differences in length

of stay, hospital pain medication requirement, or pelvic floor

six-month functional or anatomic outcomes between groups.”

However, total operating room time, anesthesia time, total

procedure time, total sacrocolpopexy time and total sutur-

ing time were all significantly longer in the robotic-assisted

group. Similarly, the robotic group reported significantly

higher pain scale scores at rest and with activity during weeks

three through six after surgery and required non-steroidal

anti-inflammatory drugs longer (19.5 vs. 9.5 days).

Dr. Paraiso says that although robotic surgery greatly

improves surgeon dexterity and ergonomics and has enabled

surgeons to overcome some of the limitations of conventional

laparoscopy, this study provides valuable insight regarding

future application of the technology.

“One of the barriers to widespread adoption of robotics is the

lack of high-quality data such as this. Certainly, insurance

companies are asking for this kind of quantifiable data to

determine reimbursement,” she says. Her team currently is

engaged in a similar study of conventional vs. robotic-assisted

laparoscopic hysterectomy with Brigham and Women’s

Hospital in Boston. ◆

Dr. Paraiso specializes in laparoscopic surgery, vaginal reconstructive surgery, prolapse and incontinence in the Ob/Gyn & Women’s Health Institute and the Glickman Urological & Kidney Institute. Physicians may contact her at 216.444.3428 or [email protected].

Laparoscopic vental rectopexy with sacral colpoperineopexy

12 ClevelanD CliniC Ob/Gyn & WOMen’S HealTH PeRSPeCTiveS | WinTeR 2010


Selected Publications From Cleveland Clinic’s Ob/Gyn & Women’s Health Institute

Journal Publications

Abdelhafez FF, Desai N, Abou-Setta AM, Fal-cone T, Goldfarb J. Slow freezing, vitrification and ultra-rapid freezing of human embryos: a systematic review and meta-analysis. Reprod Biomed Online. 2010 Feb;20(2):209-222.

Aft R, Naughton M, Trinkaus K, Watson M, ylagan L, Chavez-MacGregor M, Zhai J, Kuo S, Shannon W, Diemer K, Herrmann V, Dietz J, Ali A, Ellis M, Weiss P, Eberlein T, Ma C, Fracasso PM, Zoberi I, Taylor M, Gillanders W, Pluard T, Mortimer J, Weilbaecher K. Effect of zoledronic acid on disseminated tumour cells in women with locally advanced breast cancer: an open label, randomised, phase 2 trial. Lancet Oncol. 2010 May;11(5):421-428.

Belinson JL, Hu S, Niyazi M, Pretorius RG, Wang H, Wen C, Smith JS, Li J, Taddeo FJ, Burchette RJ, Qiao yL. Prevalence of type-specific human papillomavirus in endocervical, upper and lower vaginal, perineal and vaginal self-collected specimens: Implications for vaginal self-collection. Int J Cancer. 2010 Sep 1;127(5):1151-1157.

Bradley CS, Rahn DD, Nygaard IE, Barber MD, Nager CW, Kenton KS, Siddiqui Ny, Abel RB, Spino C, Richter HE. The questionnaire for urinary incontinence diagnosis (QUID): valid-ity and responsiveness to change in women undergoing non-surgical therapies for treatment of stress predominant urinary incontinence. Neurourol Urodyn. 2010 Jun;29(5):727-734.

Chen CCG, Korn A, Klingele C, Barber MD, Paraiso MFR, Walters MD, Jelovsek JE. Objec-tive assessment of vaginal surgical skills. Am J Obstet Gynecol. 2010 Jul;203(1):79.e1-79.e8.

Desai N, AbdelHafez F, Drazba J, Goldfarb J, Falcone T. A simple and efficient method for preparation of isolated ovarian follicles for transmission electron microscopy. J Assist Reprod Genet. 2010 Feb;27(2-3):97-101.

Desai N, Sabanegh E Jr, Kim T, Agarwal A. Free radical theory of aging: implications in male infertility. Urology. 2010 Jan;75(1):14-19.

Diwadkar GB, Jelovsek JE. Measuring surgical trainee perceptions to assess the operating room educational environment. J Surg Educ. 2010 Jul-Aug;67(4):210-216.

du Plessis SS, Cabler S, McAlister DA, Sa-banegh E, Agarwal A. The effect of obesity on sperm disorders and male infertility. Nat Rev Urol. 2010 Mar;7(3):153-161.

du Plessis SS, McAllister DA, Luu A, Savia J, Agarwal A, Lampiao F. Effects of H(2)O(2) exposure on human sperm motility parameters, reactive oxygen species levels and nitric oxide levels. Andrologia. 2010 Jun;42(3):206-210.

Escobar PF, Bedaiwy MA, Fader AN, Falcone T. Laparoendoscopic single-site (LESS) surgery in patients with benign adnexal disease. Fertil Steril. 2010 Apr;93(6):2074.e7-2074.e10.

Escobar PF, Starks DC, Fader AN, Barber M, Rojas-Espalliat L. Single-port risk-reducing salpingo-oophorectomy with and without hysterectomy: surgical outcomes and learn-ing curve analysis. Gynecol Oncol. 2010 Oct;119(1):43-47.

Fader AN, Cohen S, Escobar PF, Gunderson C. Laparoendoscopic single-site surgery in gynecology. Curr Opin Obstet Gynecol. 2010 Aug;22(4):331-338.

Falcone T. Adnexal masses: when to observe, when to intervene, and when to refer. Obstet Gynecol. 2010 Apr;115(4):680-681.

Farley J, Rose PG. Trial design for evaluation of novel targeted therapies. Gynecol Oncol. 2010 Feb;116(2):173-176.

Firoozi F, Ingber MS, Goldman HB. Pure trans-vaginal removal of eroded mesh and retained foreign body in the bladder. Int Urogynecol J Pelvic Floor Dysfunct. 2010 Jun;21(6):757-760.

Firoozi F, Goldman HB. Transvaginal excision of mesh erosion involving the bladder after mesh placement using a prolapse kit: a novel tech-nique. Urology. 2010 Jan;75(1):203-206.

French DB, Sabanegh ES, Jr., Goldfarb J, Desai N. Does severe teratozoospermia affect blastocyst formation, live birth rate, and other clinical outcome parameters in ICSI cycles? Fertil Steril. 2010 Mar 1;93(4):1097-1103.

Frick AC, Walters MD, Larkin KS, Barber MD. Risk of unanticipated abnormal gynecologic pathology at the time of hysterectomy for uterovaginal prolapse. Am J Obstet Gynecol. 2010 May;202(5):507.e1-507.e4.

Gill BC, Moore C, Damaser MS. Postpartum stress urinary incontinence: Lessons from ani-mal models. Expert Rev Obstet Gynecol. 2010 Sep;5(5):567-580.

Gill IS, Advincula AP, Aron M, Caddedu J, Canes D, Curcillo PG, II, Desai MM, Evanko JC, Falcone T, Fazio V, Gettman M, Gumbs AA, Haber GP, Kaouk JH, Kim F, King SA, Ponsky J, Remzi F, Rivas H, Rosemurgy A, Ross S, Schauer P, Sotelo R, Speranza J, Sweeney J, Teixeira J. Consensus statement of the consor-tium for laparoendoscopic single-site surgery. Surg Endosc. 2010 Apr;24(4):762-768.

Kader A, Choi A, Sharma RK, Falcone T, Agarwal A. Effect of varying equilibration time in a two-step vitrification method on the post-warming DNA integrity of mouse blastocysts. Fertil Steril. 2010 May 15;93(8):2640-2645.

Kader A, Falcone T, Sharma RK, Mangrola D, Agarwal A. Slow and ultrarapid cryopreserva-tion of biopsied mouse blastocysts and its effect on DNA integrity index. J Assist Reprod Genet. 2010 Aug;27(8):509-515.

Kader A, Sharma RK, Falcone T, Agarwal A. Mouse blastocyst previtrification interventions and DNA integrity. Fertil Steril. 2010 Mar 15;93(5):1518-1525.

Liu Z, Belinson SE, Li J, yang B, Wulan N, Tresser NJ, Wang C, Mohr M, Zhang L, Zhou y, Weng L, Wu R, Belinson JL. Diagnostic effi-cacy of real-time optical coherence tomography in the management of preinvasive and invasive neoplasia of the uterine cervix. Int J Gynecol Cancer. 2010 Feb;20(2):283-287.

Mahfouz RZ, du Plessis SS, Aziz N, Sharma R, Sabanegh E, Agarwal A. Sperm viability, apop-tosis, and intracellular reactive oxygen species levels in human spermatozoa before and after induction of oxidative stress. Fertil Steril. 2010 Feb;93(3):814-821.

Moore HCF, Budd GT, Sikon A, Rim A, Chell-man-Jeffers M, Crowe J. Sorting through the recent controversies in breast cancer screening. Cleve Clin J Med. 2010 Feb;77(2):76-79.

Muffly TM, Boyce J, Kieweg SL, Bon-ham AJ. Tensile strength of a surgeon's or a square knot. J Surg Educ. 2010 Jul-Aug;67(4):222-226.



Selected Publications From Cleveland Clinic’s Ob/Gyn & Women’s Health Institutecontinued

Muffly TM, Barber MD. Insertion and removal of vaginal mesh for pelvic organ prolapse. Clin Obstet Gynecol. 2010 Mar;53(1):99-114.

Muffly TM, Penick ER, Tang F, Bonham AJ, Smith RP, Hill RFC, Blandon RE. Factors used by female pelvic medicine and reconstructive surgery fellowship directors to select their fel-lows. Int Urogynecol J Pelvic Floor Dysfunct. 2010 Mar;21(3):349-352.

Mukhopadhyay D, Varghese AC, Pal M, Baner-jee SK, Bhattacharyya AK, Sharma RK, Agarw-al A. Semen quality and age-specific changes: a study between two decades on 3,729 male partners of couples with normal sperm count and attending an andrology laboratory for infertility-related problems in an Indian city. Fertil Steril. 2010 May 1;93(7):2247-2254.

Novara G, Artibani W, Barber MD, Chapple CR, Costantini E, Ficarra V, Hilton P, Nilsson CG, Waltregny D. Updated systematic review and meta-analysis of the comparative data on colposuspensions, pubovaginal slings, and midurethral tapes in the surgical treatment of female stress urinary incontinence. Eur Urol. 2010 Aug;58(2):218-238.

O'Flynn O'Brien KL, Varghese AC, Agarwal A. The genetic causes of male factor infertility: a review. Fertil Steril. 2010 Jan;93(1):1-12.

Park AJ, Barber MD, Bent AE, Dooley yT, Dancz C, Sutkin G, Jelovsek JE. Assessment of intraoperative judgment during gynecologic surgery using the Script Concordance Test. Am J Obstet Gynecol. 2010 Sep;203(3):240-246.

Powell MA, Filiaci VL, Rose PG, Mannel RS, Hanjani P, Degeest K, Miller BE, Susumu N, Ueland FR. Phase II evaluation of pa-clitaxel and carboplatin in the treatment of carcinosarcoma of the uterus: a Gynecologic Oncology Group study. J Clin Oncol. 2010 Jun 1;28(16):2727-2731.

Ragheb AM, Sabanegh ES, Jr. Male fertility-implications of anticancer treatment and strate-gies to mitigate gonadotoxicity. Anticancer Agents Med Chem. 2010 Jan 1;10(1):92-102.

Richter HE, Burgio KL, Brubaker L, Nygaard IE, ye W, Weidner A, Bradley CS, Handa VL, Borel-lo-France D, Goode PS, Zyczynski H, Lukacz ES, Schaffer J, Barber M, Meikle S, Spino C. Continence pessary compared with behavioral therapy or combined therapy for stress incon-tinence: a randomized controlled trial. Obstet Gynecol. 2010 Mar;115(3):609-617.

Rose PG, Ali S, Whitney CW, Lanciano R, Stehman FB. Impact of hydronephrosis on outcome of stage IIIB cervical cancer patients with disease limited to the pelvis, treated with radiation and concurrent chemotherapy: a Gynecologic Oncology Group study. Gynecol Oncol. 2010 May;117(2):270-275.

Rose PG, Tian C, Bookman MA. Assessment of tumor response as a surrogate endpoint of survival in recurrent/platinum-resistant ovarian carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2010 May;117(2):324-329.

Sajadi KP, Goldman HB. Percutaneous tibial nerve stimulation and overactive bladder. Curr Urol Rep. 2010 Sep;11(5):293-295.

Samplaski MK, Agarwal A, Sharma R, Sa-banegh E. New generation of diagnostic tests for infertility: review of specialized semen tests. Int J Urol. 2010 Oct;17(10):839-847.

Sikon A, Batur P. Profile of teriparatide in the management of postmenopausal osteoporosis. Int J Women Health. 2010;2(1):37-44.

Sikon A, Bronson DL. Shared medical ap-pointments: challenges and opportunities. Ann Intern Med. 2010 Jun 1;152(11):745-746.

Siraj ES, Abacan C, Chinnappa P, Wojtowicz J, Braun W. Risk factors and outcomes associated with posttransplant diabetes mellitus in kidney transplant recipients. Transplant Proc. 2010 Jun;42(5):1685-1689.

Skaznik-Wikiel ME, Jelovsek JE, Andrews B, Bradley LD. Accuracy of endometrial thickness in detecting benign endometrial pathology in postmenopausal women. Menopause. 2010 Jan;17(1):104-108.

Staskin D, Kay G, Tannenbaum C, Goldman HB, Bhashi K, Ling J, Oefelein MG. Trospium chloride has no effect on memory testing and is assay undetectable in the central nervous sys-tem of older patients with overactive bladder. Int J Clin Pract. 2010 Aug;64(9):1294-1300.

Swartz M, Vasavada S, Goldman H. Reply [Perioperative management of patients under-going sling surgery: A survey of US urologists]. Urology. 2010 Aug;76(2):318.

Swartz M, Ching C, Gill B, Li J, Rackley R, Va-savada S, Goldman HB. Reply [Risk of infection after midurethral synthetic sling surgery: are postoperative antibiotics necessary?]. Urology. 2010 Jun;75(6):1309.

Swartz M, Ching C, Gill B, Li J, Rackley R, Vasavada S, Goldman HB. Risk of infection after midurethral synthetic sling surgery: are postoperative antibiotics necessary? Urology. 2010 Jun;75(6):1305-1308.

Swartz M, Vasavada S, Goldman H. Periopera-tive management of patients undergoing sling surgery: a survey of US urologists. Urology. 2010 Aug;76(2):314-317.

von Gruenigen VE, Huang HQ, Gil KM, Gib-bons HE, Monk BJ, Rose PG, Armstrong DK, Cella D, Wenzel L. A comparison of quality-of-life domains and clinical factors in ovarian cancer patients: a Gynecologic Oncology Group study. J Pain Symptom Manage. 2010 May;39(5):839-846.

Wang C, Michener CM, Belinson JL, Vaziri S, Ganapathi R, Sengupta S. Role of the 18:1 lysophosphatidic acid-ovarian cancer immunoreactive antigen domain containing 1 (OCIAD1)-integrin axis in generating late-stage ovarian cancer. Mol Cancer Ther. 2010 Jun;9(6):1709-1718.

Wulan N, Rasool N, Belinson SE, Wang C, Rong X, Zhang W, Zhu y, yang B, Tresser NJ, Mohr M, Wu R, Belinson JL. Study of the diag-nostic efficacy of real-time optical coherence tomography as an adjunct to unaided visual inspection with acetic acid for the diagnosis of preinvasive and invasive neoplasia of the uterine cervix. Int J Gynecol Cancer. 2010 Apr;20(3):422-427.

Books

Falcone T, Goldberg JM. Basic, Advanced, and Robotic Laparoscopic Surgery. Philadelphia, PA: Saunders/Elsevier, 2010.

Le T, Bhushan V, Sheikh-Ali M, Abu Shahin F. First Aid for the USMLE Step 2 CS. 3rd ed. New york, Ny: McGraw-Hill, 2010.

Walters MD, Barber MD. Hysterectomy for Benign Disease. Philadelphia, PA: Saunders Elsevier, 2010.

14 CLEVELAND CLINIC OB/GyN & WOMEN’S HEALTH PERSPECTIVES | WINTER 2010


Physician Resources

Medical editor Majan Attaran, MD

Managing editorMarjie Heines

Art DirectorAnne Drago

PhotographersDon Gerda, Russell Lee, Tom Merce, Steve Travarca

IllustrationJoe Pangrace, Mark Sabo

Marketing Lori Schmitt, RN, Melissa Raines

Ob/Gyn & Women’s Health Perspectives is written for physicians and should be relied upon for medical education purposes only. It does not provide a complete overview of the topics covered, and should not replace the independent judgment of a physician about the appropriateness or risks of a procedure for a given patient.

© The Cleveland Clinic Foundation 2010

PHysICIAn DIReCtORy View all Cleveland Clinic staff online at

clevelandclinic.org/staff. To request a printed version of the Ob/Gyn directory,

call Susan Anton at 216.448.1020.

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