<p>Table 15. Characteristics of studies comparing vas occlusion techniques with and without fascial interposition </p><p>Authors Type of Study Subject’s Eligibility Criteria Sample Size* Setting Study Period Interventions Type and Number and Year of of Surgeons Publication Isolation Occlusion Method Method Schmidt 1973 Case series with Unspecified No FI: 150 Office, Between 1955 and 1961 Two lateral No FI: Double ligation with One urologist [20] historical openings cotton each end + Excision controls FI: 135 USA (10 mm) FI: Same + FI with suture (prostatic end) Rhodes et al. Case series with Unspecified No FI: 28 Unspecified, Unspecified Two lateral No FI: Vas transected Unspecified historical openings 1980 [46] controls FI: 12 USA FI: Same + FI with suture (end?) Li et al. Non-randomized Healthy volunteers who had had more No FI: 186/215 Five family Vasectomies done April NSV No FI (G): Open-end Various experienced trial. Subjects than 2 children (Group G) planning services, 1988 through March 1990 (>2,000 vasectomies) 1994 [32] divided in 7 plus two-year follow-up FI (A) Open-end + FI (end?) operators. Each groups (A to G) FI:183/200 (Group China technique done by A) No FI (B): Ligation with silk on both ends operators from 2 No FI: 427/488 different institutions FI (C): Same as B + FI (Group B) (testicular end) FI: 380/431 (Group In all groups, excision (10- C) 15 mm) De Los Rios Case series with All vasectomies performed between No FI: 550 Profamilia Male Vasectomies done between No FI: Two No FI: Ligation with At least two urologists et al. historical 1971 and 1991 Clinic in Medellin 1971 and 1991 lateral openings various suture materials + controls FI: 4,015 Colombia Excision (10 mm) (in a teaching center) 1994-2003 FI: Two lateral [25,26] openings, FI: Same + FI sutured only if bleeding (41%) and NSV (59%) Sokal et al. Randomized Healthy, sexually active men at least No FI: 422 8 research centers Recruitment from NSV No FI : Ligation with silk + Various surgeons who clinical trial 18 years old who had chosen worldwide: USA, November 1999 to May Excision (10mm) attended a 2003 [45] vasectomy for contraception FI: 419 Mexico (2 sites), El 2001 Recruitment halted standardization Salvador, Panama, after interim analyses FI : Same + FI (testicular meeting Total initially end) planned: 1,200 Sri Lanka, Nepal showing superiority of FI</p><p>*Number of subjects analysed/total number of subjects enrolled in the study. FI: fascial interposition, NSV: no-scalpel vasectomy. Table 16. Outcome measures of studies comparing vas occlusion techniques with and without fascial interposition</p><p>Authors and Effectiveness Complications Year of Publication Data Length of Post-vasectomy Semen Analysis (SA) Data Collection Length of Method of Main Outcome Measures Collection Follow-up Follow-up Follow-up Timing of SA Definition of Failure</p><p>Schmidt Retrospective Unspecified but Unspecified No number, motility nor Retrospective Unspecified but Unspecified Granuloma: leakage of sperm from the variable time specified. Sterility with variable proximal vas 1973 [20] 2 negative specimens, 1 month apart</p><p>Rhodes et al. Retrospective Unspecified but Unspecified No number, motility nor N/A N/A N/A N/A variable time specified but SA 1980 [46] results in failure described Li et al. Prospective 2 years 6 months intervals until 2 Presence of sperm two years Prospective 2 years Follow-up visits Bleeding, infection, stasis years post vasectomy after vasectomy every 6 months 1994 [32] De Los Rios et al. Retrospective At least 3 3 months or after 20 Presence of live Retrospective Unspecified Early post- Infection, bleeding, pain, granuloma, months but ejaculations spermatozoa four months vasectomy orchi-epididymitis, sexual dysfunction 1994-2003 [25,26] variable after vasectomy follow-up visit and spontaneous medical consultations Sokal et al. Prospective 12 months 2 weeks, then every 4 weeks Early: > 5 million motile Prospective 12 months Follow-up visits Surgical difficulties and adverse events: through 34 weeks or until sperm/mL at 14 weeks or at the time of SA pain, sperm granuloma, orchi- 2003 [45] success or failure, and 52 later epididymitis, hematoma, infection weeks Late: motile sperm at > 26 weeks or later (>10% motile and >100,000 sperm/mL)</p><p>N/A: not applicable, SA: semen analysis. Table 17. Quality assessment of studies comparing vas occlusion techniques with and without fascial interposition * n o n Sample Size Comparability Effectiveness Assessment Complication Assessment i g t i</p><p> r s e e a a e e a * d * * * g p * d * d l l l s t t i i e l l t t z c r e e e e a o e n u y t r r n i a i m m t i i d t t - t n e n d d l r i e i e A A t i n a r i D S o a t a t t e e l n n</p><p> e e b v i i w w p T T i i i p e n n T </p><p> i r r e y R R l l o i i o u o P m m l b u e e c S l m r d s C C s - i l B B p P P a s p d p d y t s P s</p><p> u t m t m o s r r e e f w d i u i u e e t m a a e a F a - - s s o o c c u a S s m m</p><p> l i S i S t s s P p</p><p> l l l s r r w w S r S e e o p o p o A A o o a m A</p><p> f l f l h h</p><p> x x F e l l r r o t t e e l</p><p> t t / E e o E e o t t a Y C e a a P P F F b</p><p>A A c d u u e o y y t n l q n q l l a a l l e e a i G</p><p> a a l u d d s c c p q i i r A A t t e o m a a d o h t m m A C e e u t t s s A y y S S n n e e M M Schmidt 3 285 0.32 ? No ? Yes No Yes ? No No ? Yes ? No ? No No ? ? No ? Very Low 1973 [20] Rhodes et 3 40 0.08 ? No ? ? No ± Yes No No ? Yes ? No 97.5% N/A N/A Very Low al. 1980 [46] Li et al. 2 807/ 0.70/ No Yes No No Yes Yes Yes Yes Yes ? Yes Yes Yes 88%/89%† No No Yes Yes No 88%/89%† Moderate 369† 1994 [32] 0.39† De Los Rios 3 4565 0.97 Yes No Yes No Yes No ? No Yes No Yes ? No 55% No No Yes ? No 55% Very Low et al. 1994-2003 [25,26] Sokal et al. 1 841 0.86‡ Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes No FI: 98.6% No No Yes Yes No 6 weeks High</p><p>2003 [45] FI: 97.9% 100% 12 months 89%</p><p>*Criterion used for global assessment (see Table 2, Additional file 1). FI: fascial interposition, N/A: not applicable. † group A and G / group B and C. ‡ Sample size when study halted (n=841)/sample size initially planned (n=1,200).</p><p>Table 18. Results of studies comparing vas occlusion techniques with and without fascial interposition</p><p>Authors and Effectiveness (Failure) Complications Year of Hematoma Infections Pain Granuloma Epididymitis Others Total publication Based on SA Based on Comments Comments Pregnancy Schmidt No FI: 3.3% Lower failure risk with No FI: 6.0% No other complication FI when ligation specified. Higher risk of 1973 [20] FI: 0% /excision performed FI: 9.7% granulomas defined as sperm leakage with FI Rhodes et al. No FI: 6 Similar failure risk with Complications (21.4%) and without FI when only unspecified 1980 [46] vas transected. Very FI: 2 (16.7%) small sample size P = 0.55 Li et al. No FI (G): 14 No FI (G): 1 G vs A: Lower failure Bleeding No FI (G): 1 Stasis No FI (G): 8 Higher risk of (7.5%) (0.5%) risk with FI when open- FI (A): 0 (2.2%) complications due to 1994 [32] end is performed No FI (G): 7 No FI (G): 0 bleeding in group G FI (A) :1 (0.6%) FI (A) :1 FI (A) :0 No FI (B): 2 FI (A) :0 FI (A): 0 (open-end without FI). (0.6%) B vs C: Higher failure No FI (B): 6 No FI (B):0 FI (C): 1 No FI (B):0 No FI (B): 2 Total risk of (undefined) risk with FI (testicular) complications very low (1.4%) No FI (B): 2 when ligation/excision is (0.5%) (0.5%) FI (C): 0 FI (C): 1 FI (C):10 (2.6%) performed FI (C): 2 FI (C): 6 Large variation between (0.5%) 0 (1.6%) centers De Los Rios et No FI: 94 Lower failure risk with Complications al. (29.1%) FI when ligation unspecified /excision performed 1994-2003 FI: 57 (2.6%) [25,26] Sokal et al. No FI: 53 No FI: 2 Lower failure risk with No FI: 6 No FI: 2 52 weeks No FI: 29 No FI: 6 6 weeks Non significant higher (12.7%) (0.5%) FI when ligation (1.4%) (0.5%) (6.9%) (1.4%) risk of complications due 2003 [45] /excision performed No FI: 14 No FI: 62 to granuloma and orchi- FI: 24 (5.9%) FI: 2 (0.5%) FI: 6 (1.4%) FI: 2 (0.5%) (4.3%) FI: 41 (9.8%) FI: 12 (2.9%) (14.7%) epididymitis with FI. Time to azoospermia and P < 0.0008 FI: 9 FI: 74 Same risk of hematoma to severe oligospermia and infection shorter with FI (2.6%) (17.7%) (P < 0.0001) P = 0.23</p><p>SA: semen analysis, FI: fascial interposition.</p>