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www.gi-supply.com Page 1 of 3 Lesion Localization Errors Pose Significant Risks: Why Endoscopic Tattooing Should be Routine Introduction The care of colorectal cancer patients is a partnership between the gastroenterologist and the surgeon. In order to provide the highest medical care possible, precise localization of colorectal lesions must be a top priority for both physicians. Studies have shown that colonoscopy alone is insufficient for the surgeon to quickly and accurately identify lesions. 1,2,3 There are several risks associated with poor lesion localization, 4 the most significant being wrong site surgery. Both the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and the American Society for Gastrointestinal Endoscopy (ASGE) have recognized the high risk of resecting the wrong section of bowel without accurate preoperative lesion identification. 5,6 Endoscopic tattooing can help mitigate these risks with an easy, fast method for the gastroenterologist to employ and a clear, precise marker for the surgeon to visualize. Keywords colon cancer • colonoscopy • localization • endoscopic tattoo • patient safety Tumor Location Can be Imprecise Surgeons employ various methods for locating colorectal lesions, the most prominent being the referring gastroenterologists notes, either through pre-surgery communication or the colonoscopy procedure report, and/or localization techniques like tattooing, clips or CT scans/x-rays. 7 However, using the referring gastroenterologist’s notes alone can pose significant risks to the patient. The anatomy of the colon along with varying endoscopic and surgical techniques can make it difficult to find unmarked lesions during follow- up surgery and surveillance. The American Society for Gastrointestinal Endoscopy (ASGE) Technology Committee says the “estimation of the tumor site at colonoscopy can be imprecise, with as many as 14% of tumor locations incorrectly identified.” 8 Another study shows that “approximately 10%-20% of tumor locations identified from colonoscopy (alone) are inconsistent with the intraoperative tumor site.” 9 It becomes even harder to find lesions during surgical intervention if previous colorectal procedures have been performed. The rise in laparoscopic colorectal surgery has also made it difficult to rely solely on colonoscopy for lesion location. While numerous studies have been published about the benefits of laparoscopic versus open surgery, colon lesions pose a unique challenge to surgeons. Tactile sensation is no longer available and palpation of the colon is blunted, 10,11,12 therefore lesions may be difficult to find regardless of how precise the referring gastroenterologist’s notes are. The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Guidelines for Laparoscopic Resection of Curable Colon and Rectal Cancer states, “when approaching the colon resection laparoscopically, every effort should be made to localize the tumor preoperatively.” 13 Gastroenterologists and endoscopists have several options for lesion localization, with the prevailing technique being endoscopic tattooing. Different studies have discussed barium enema, CT colonography, and marking the lesion with metal clips, but due to accuracy, availability, cost, and time, tattooing is seen as the most practical option. 14,15,16 The tattoo is a permanent communication tool about the patient for members of the surgical and surveillance teams. The Risks: Longer Procedures and Wrong Site Surgery Incorrect colorectal lesion localization puts the patient, surgeon, and gastroenterologist at risk. In a recent industry research poll, 100% of colorectal and general surgeons surveyed saw a Copyright © 2014 by GI Supply Email: [email protected]

Lesion localization errors pose significant risks: why endoscopic tattooing should be routine

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Lesion Localization Errors Pose Significant Risks: Why Endoscopic Tattooing Should be Routine

Introduction

The care of colorectal cancer patients is a partnership between the gastroenterologist and the surgeon. In

order to provide the highest medical care possible, precise localization of colorectal lesions must be a top

priority for both physicians. Studies have shown that colonoscopy alone is insufficient for the surgeon to

quickly and accurately identify lesions.1,2,3 There are several risks associated with poor lesion localization,4

the most significant being wrong site surgery. Both the Society of American Gastrointestinal and

Endoscopic Surgeons (SAGES) and the American Society for Gastrointestinal Endoscopy (ASGE) have

recognized the high risk of resecting the wrong section of bowel without accurate preoperative lesion

identification.5,6 Endoscopic tattooing can help mitigate these risks with an easy, fast method for the

gastroenterologist to employ and a clear, precise marker for the surgeon to visualize.

Keywords colon cancer • colonoscopy • localization • endoscopic tattoo • patient safety

Tumor Location Can be Imprecise

Surgeons employ various methods for locating

colorectal lesions, the most prominent being the

referring gastroenterologists notes, either

through pre-surgery communication or the

colonoscopy procedure report, and/or

localization techniques like tattooing, clips or

CT scans/x-rays.7 However, using the referring

gastroenterologist’s notes alone can pose

significant risks to the patient.

The anatomy of the colon along with varying

endoscopic and surgical techniques can make it

difficult to find unmarked lesions during follow-

up surgery and surveillance. The American

Society for Gastrointestinal Endoscopy (ASGE)

Technology Committee says the “estimation of

the tumor site at colonoscopy can be imprecise,

with as many as 14% of tumor locations

incorrectly identified.”8 Another study shows

that “approximately 10%-20% of tumor

locations identified from colonoscopy (alone)

are inconsistent with the intraoperative tumor

site.”9 It becomes even harder to find lesions

during surgical intervention if previous

colorectal procedures have been performed.

The rise in laparoscopic colorectal surgery has

also made it difficult to rely solely on

colonoscopy for lesion location. While

numerous studies have been published about the

benefits of laparoscopic versus open surgery,

colon lesions pose a unique challenge to

surgeons. Tactile sensation is no longer available

and palpation of the colon is blunted, 10,11,12

therefore lesions may be difficult to find

regardless of how precise the referring

gastroenterologist’s notes are. The Society of

American Gastrointestinal and Endoscopic

Surgeons (SAGES) Guidelines for Laparoscopic

Resection of Curable Colon and Rectal Cancer

states, “when approaching the colon resection

laparoscopically, every effort should be made to

localize the tumor preoperatively.”13

Gastroenterologists and endoscopists have

several options for lesion localization, with the

prevailing technique being endoscopic tattooing.

Different studies have discussed barium enema,

CT colonography, and marking the lesion with

metal clips, but due to accuracy, availability,

cost, and time, tattooing is seen as the most

practical option.14,15,16 The tattoo is a permanent

communication tool about the patient for

members of the surgical and surveillance teams.

The Risks: Longer Procedures and

Wrong Site Surgery

Incorrect colorectal lesion localization puts the

patient, surgeon, and gastroenterologist at risk.

In a recent industry research poll, 100% of

colorectal and general surgeons surveyed saw a Copyright © 2014 by GI Supply

Email: [email protected]

Page 2: Lesion localization errors pose significant risks: why endoscopic tattooing should be routine

www.gi-supply.com Page 2 of 3

risk with not having the colon or rectal lesion

site tattooed prior to surgery.17 Risks noted

include:

Removing the wrong section of bowel

Removing more/less of the colon than needed

Longer surgery times

Patients having to undergo another surgery

Having to move to an open procedure

Having to perform intra-operative

colonoscopy

Major medical organizations such as ASGE and

SAGES have published information that states

inaccurate lesion identification can lead to the

wrong section of colon being removed.18,19

Additionally, numerous papers published in

journals such as Surgical Endoscopy,20

Colorectal Disease,21 The World Journal of

Gastrointestinal Endoscopy,22 and JAMA

Surgery (formerly Archives of Surgery)23 have

echoed the same statements: “without precise

preoperative localization, it is possible to

remove an incorrect segment of intestine.”24

Wrong site surgery is also a crucial factor in the

Joint Commission’s National Patient Safety

Goals. The “mark the procedure site” section of

the JACHO’s Universal Protocol for Preventing

Wrong Site, Wrong Procedure says “marking the

procedure site is one way to protect patients;

patient safety is enhanced when a consistent

marking process is used through the hospital.”25

Inconsistent or absent marking of colorectal

lesions can also cause risks other than wrong site

surgery. Vaziri et al26 noted that inaccurate

localization may result in a change in the

operation performed, while Piscatelli et al27

stated that it can put the patient at risk for

inappropriate trocar placement and prolonged

surgery and anesthesia. Still other studies have

commented on the risks for additional blood

loss28 and the need for intraoperative

colonoscopy.

Colonoscopy in the operating room poses its

own challenges by being “time-consuming,

technically difficult, and cumbersome because

of positioning of the patient on the table. In

addition, colonic insufflation, even with

proximal bowel occlusion, can sacrifice

intraperitoneal domain, limit operative exposure,

and severely handicap the laparoscopic

surgeon.”29,30 This procedure also prolongs

surgical and anesthesia time for the patient.

Discussion

Colonoscopy has become the most commonly

used screening test for colon cancer in the

United States.31 However, colonoscopy alone is

not enough to prevent wrong site colorectal

surgery and longer surgical times for colon

resections. Recent industry research shows that

92% of colorectal and general surgeons

surveyed think endoscopic tattooing should be a

Practice Guideline or Standard of Care.32 In

order to increase patient safety, many studies

suggest endoscopic tattooing should be used

routinely by gastroenterologists and

endoscopists to assist the surgeon in locating

colorectal lesions in an accurate, timely manner.

In addition to the numerous medical risks the

patient faces for inaccurate lesion localization,

both the gastroenterologist and surgeon may

face legal ramifications for wrong site surgery

and complications that can result from longer

surgical times.

To read more about the legal risks associated

with wrong site colon surgery, please visit

www.gi-supply.com/casereview.

1 Solon JG at al. Colonoscopy and computerized tomography scan are not sufficient to localize right-sided colonic lesions

accurately. Colorectal Dis. 2010 Oct;12(10 Online):e267-72. 2 Trakarnsanga A et al. Endoscopic tattooing of colorectal lesions: Is it a risk-free procedure? World J Gastrointest Endosc. Dec

16, 2011; 3(12): 256–260. 3 Piscatelli N et al. Localizing colorectal cancer by colonoscopy. Arch Surg. 2005 Oct;140(10):932-5. 4 Salloway & Associates, Inc. Cancer Lesion Tattooing Research Results. 2014 Sep. 5 SAGES. Guidelines for Laparoscopic Resection of Curable Colon and Rectal Cancer. 2012 Feb. 6 ASGE Technology Committee. Endoscopic tattooing. Gastrointest Endosc. 2010 Oct;72(4):681-5. 7 Salloway & Associates, Inc.

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8 ASGE Technology Committee. 9 Trakarnsanga A et al. 10 Zmora O et al. Laparoscopic colectomy for colonic polyps. Surg Endosc. 2009 Mar;23(3):629-32. 11 Vaziri K et al. Accuracy of colonoscopic localization. Surg Endosc. 2010 Oct;24(10):2502-5 12 Solon JG at al. 13 SAGES. 14 Vaziri K et al. 15 Feingold DL et al. Safety and reliability of tattooing colorectal neoplasms prior to laparoscopic resection. J Gastrointest Surg.

2004 Jul-Aug;8(5):543-6. 16 Solon JG at al. 17 Salloway & Associates, Inc. 18 ASGE Technology Committee. 19 SAGES. 20 Vaziri K et al. 21 Solon JG at al. 22 Trakarnsanga A et al. 23 Piscatelli N et al. 24 Trakarnsanga A et al. 25 The Joint Commission. National Patient Safety Goals Effective January 1, 2014. 26 Vaziri K et al. 27 Piscatelli N et al. 28 Arteaga-González I et al. The use of preoperative endoscopic tattooing in laparoscopic colorectal cancer surgery for

endoscopically advanced tumors: a prospective comparative clinical study. World J Surg. 2006 Apr;30(4):605-11. 29 Feingold DL et al. 30 Zmora O et al. 31 Lieberman DA, et al. Guidelines for colonoscopy surveillance after screening and polypectomy: a consensus update by the US

Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2012 Sep;143(3):844-57. 32 Salloway & Associates, Inc.