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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
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Shang Ring Procedure
Shang 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
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Previous Safety Studies in Africa
Pilot study, Kenya, 2009 *◦40 men
Removal 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
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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
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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
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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
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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.
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Device Related Events & an Unusual Case from Field Study
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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
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Client Satisfaction with Appearance: % “Very Satisfied”
Kenya ZambiaShang Ring 95.7% 96.8%
Conventional 85.9% 71.3%
p - value <0.02 <0.0001
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Shang ring Conventional
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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
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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
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Conclusions
Pain scores and adverse event rates similar
Shang Ring healing slower by about 5 days
Significantly 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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Acknowledgements
John Bratt
Stephanie Combes
Catherine Hart
Jaim Jou Lai
Mores Loolpapit
David Sokal
Michael Stalker
Debra Weiner
Lilian Were
Merywen Wigley
Quentin Awori
Mark Barone
Sharone Beatty
Jared Moguche
Paul Perchal
Carolyne Onyancha
Daniel Ouma
Rosemary 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
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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.