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The Shang Ring vs Conventional Surgical Techniques: an RCT in Kenya and Zambia. Session TUAC04 Male Circumcision: Strategies and Impact AIDS 2012: Tuesday, July 24. Dr. Quentin Awori. Shang Ring Procedure. Shang Ring Circumcision. 2. Place inner ring. 3. Evert foreskin. - PowerPoint PPT Presentation
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The Shang Ring vs
Conventional Surgical Techniques:
an RCT in Kenya and Zambia
Session TUAC04Male Circumcision: Strategies and Impact
AIDS 2012: Tuesday, July 24
Dr. Quentin Awori
Shang Ring ProcedureShang Ring Circumcision
1. Measure 2. Place inner ring 3. Evert foreskin 4. Place outer ring 5. Cut
2. Separate inner ring from scab
Shang Ring Removal at 7 Days
1. Open outer ring
3. Cut inner ring
4. Apply bandage
Wearing Shang Ring
Previous Safety Studies in AfricaPilot study, Kenya, 2009 *
◦40 menRemoval at Different Time Points
study, Kenya, 2010 **◦50 men◦Randomized to removal at 7, 14 or 21
daysSafe & acceptable => proceeded
to RCT
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*Mark Barone et al. JAIDS. 57:e7-e12. 2011** Mark Barone et al. JAIDS . 60:e82-9. 2012*/** Studies reviewed this morning by Sokal at session: TUSA05
RCT: Shang Ring vs. ConventionalObjectives
Compare:◦Pain◦Acceptability◦Safety – adverse events◦Ease of use of Shang Ring
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RCT: Shang Ring vs. Conventional Methods / Endpoints
Standardized Shang Ring trainingConventional techniques
◦ Kenya: forceps guided technique◦ Zambia: dorsal slit technique
Visual analog pain scale & questionnairesAdverse events
◦ Documented events related to the circumcision◦ Definitions based on WHO/PSI * guidance, except
modified wound dehiscence definition for Shang RingSurgeon questionnaires* WHO/PSI. Adverse Event Action Guide for Male Circumcision. Draft, January 2011.
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Adverse Event DefinitionsModerate Wound Dehiscence
WHO/PSI definition of wound dehiscence involves sutures
Shang Ring: no sutures => modified definition◦ Moderate: Mucocutaneous gap greater than about
1 cm and involving deeper tissues [1 cm longitudinal], but NOT requiring surgical intervention
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RCT ResultsAs Treated Population
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Kenya Zambia
Shang Ring cases 97 100
Conventional cases 103* 98**
Mean age (yrs) 20.9 24.1
Marital Status: Single 84.5% 80.3%
* One man had very thick foreskin; 2 men – ring size out of stock** Two men excluded from analysis at request of Ethics Committee due to inadequate documentation of informed consent
Kenya Zambia
1 hr post-op
Shang 4.1 3.6
Conventional 3.6 3.2
Day 2 visit
Shang 0.8 1.0
Conventional 1.1 0.9
Mean Pain Scores at Different Time Points
◦Visual Analogue Scale (VAS)◦0 = no pain to 10 = worst possible pain
8
Time to Healing from Day of Ring Application
% Healed at Day 42* (95% C.I.)
Mean # Days
Shang Ring 76.3 (70 – 82) 44.1
Conventional 85.3 (80 – 90) 38.9
Difference (95% C. I.) Not done ** 5.2 (2.7 – 7.8)
p < 0.0001
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* By life table analysis; men lost to follow-up were considered not healed at . last visit and censored. ** Not done due to study site differences in healing evaluation
Adverse Events *
10
Moderate
Infection 0 2
Wound dehiscence 6 4
Wound edema 1 0Hemorrhage 0 1
Shang Ring n=197
Conventionaln=201
Severe 0 0
Total (%) 7 (3.6%) 7 (3.5%)
* Excluding anesthesia-related events.
Device Related Events & an Unusual Case from Field Study
11
Cutaneous pinches = small fold of skin from shaft caught in Shang Ring
Late breaker:Six men had pinches => mild AE’s
Zambian man removed his own Shang Ring at day 4 using pliers
Client Satisfaction with Appearance: % “Very Satisfied”
Kenya ZambiaShang Ring 95.7% 96.8%
Conventional 85.9% 71.3%
p - value <0.02 <0.0001
12Shang ring Conventional
Ease of Procedure: Mean Duration (SD) in Minutes*
Kenya Zambia
Shang Ring* 7.0 (1.9) 7.3(2.1)
Conventional* 20.7(6.0) 19.8(2.9)
Shang Removal
2.5 (1.2) 3.7 (2.1)
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* p < 0.0001 at both sites; Mean times for circumcisions exclude anesthesia times
Ease of Surgery: Providers’ Opinions*4 non-physicians and 2 physiciansHow easy is Shang Ring vs.
conventional surgery? ◦Much easier (5/6)◦Easier (1/6)
Would you recommend Shang Ring compared to conventional surgery?◦Strong preference (5/6)◦Slight preference(1/6)
* Poster with review of providers’ opinions, including from recently completed field study, presented yesterday: Hart C , Combes S, Li PS. et al. AIDS 2012: MOPE683 14
ConclusionsPain scores and adverse event
rates similarShang Ring healing slower by
about 5 daysSignificantly more men “very
satisfied” with appearance after Shang Ring MC
Shang Ring technique took 1/3 the time of conventional techniques
Providers preferred Shang RingShang Ring should facilitate VMMC
scale-up
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AcknowledgementsJohn BrattStephanie CombesCatherine HartJaim Jou LaiMores LoolpapitDavid SokalMichael StalkerDebra WeinerLilian WereMerywen Wigley
Quentin AworiMark BaroneSharone BeattyJared Moguche Paul PerchalCarolyne OnyanchaDaniel OumaRosemary Were
Cornell (WCMC)Marc Goldstein Howard KimRichard LeePhilip S. LiPuneet Masson
KenyaAlex AdudaOjwang AyomaPeter CherutichJackson KiokoNicholas MuraguriOjwang Lusi Jairus OketchRaymond OtienoJohn Wekesa
EngenderHealthFHI 360
Supported by a grant from the Bill & Melinda Gates Foundation through FHI360
ZambiaKasonde BowaHayden HawryPrisca KasondeDaniel Mashewani Christopher Mubuyaeta David MulengaMulima MuzeyaRobert ZuluZude Zyambo
With Bupivacaine (n=30)
W’out Bupivacaine (n=168)
P-values
1 hr post-op 0.7 (1.1) 3.9 (1.6) <0.0001
Day 2 visit 1.1 (1.1) 0.9 (0.9) 0.26
Zambia: Mean Pain Scores (SD) with or without Bupivacaine (combined)
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However, men receiving bupivacaine reported more pain and more trouble sleeping the first night, p<0.01.