Table 23. Characteristics of studies comparing vas occlusion techniques with and without leaving the testicular end open
Authors
Type of Study
and Year of
Publication
Shapiro and
Silber
Prospective
cohort study
Subject’s Eligibility Criteria
Sample Size*
Setting
Study Period
Interventions
Isolation
Method
Unspecified. Close-ended only from
St-Louis, Missouri
1979 [15]
O: 433
Unspecified,
410 from Canada
Canada
23 from Missouri
USA
1 year (78?)
Unspecified
1983 [48]
Case series with
historical
controls
Unspecified
O: 4
C: 387
Method
O: Ligation with Hemoclip
(n=?) (262) or TC (Concept®)
on prostatic end (148 + 23)
Two urologists
C: TC on both ends.
C: 91
Goldstein
Occlusion
Type and Number
of Surgeons
Excision in both groups?
Out-Patient clinic in Unspecified
tertiary care
university hospital,
Two lateral
incisions
O: Excision (5 mm) + TC (5
mm) on prostatic end
One urologist
C: ?
USA
Errey and
Edwards
1986 [13]
Moss
1992 [14]
Li et al.
1994 [32]
Case series with
historical
controls
Unspecified
Case series with
historical
controls
Unspecified
Non-randomized
trial. Subjects
divided in 7
groups (A to G)
Healthy volunteers who had had more
than 2 children
O: 4,330
Out Patient Fertility O: 1979 to June 1984
Control Clinic,
C: 1976 to 1979
Australia
Two lateral
incisions
O: 3,139 (3,103?)
Unspecified,
C: 3,081
USA
O: October 1979 to April
1992
One midline
opening
O: Same as close-ended but
testicular end uncauterized
C: June 1972 to September
1979
Until 1989
and NSV
thereafter
C: TC on both ends +FI on
prostatic end with an
Hemoclip.
Vasectomies performed
from April 1988 to March
1990 + a 2-year follow-up
period
NSV
O: Ligation with silk on
prostatic end and FI (200) or
not (215)
C: 3,867
O: 369/415 (group
A and G)
Five family
planning services,
C: 2,004/2,298
(group B, C, D, E,
and F)
China
O: Same as close-ended but
testicular end uncauterized
One provider
C: Ligation with Nylon 3-0 +
Excision (2-5 mm) + EC on
both ends + FI on prostatic end
+ FB of both ends.
C: Various occlusive methods
but all close-end
One gynaecologist
Various experienced
(>2,000 vasectomies)
operators. Each
technique done by
operators from 2
different institutions
Excision(10 -15 mm) in all
groups excepted D
Labrecque et Case series with
al. 1998 [33] concurrent
controls
All men with a first bilateral
vasectomy between 1994 and 1996
O: 322/448
C: 545/775
Excluded: technique not performed as
usual (n=9)
O: Family planning
clinic in a tertiary
care hospital
January 1994 to February
1996
NSV
C: Office,
C: Ligation with 2 Hemoclips
per vas + Excision (10 mm)
Canada
Labrecque et
al. 2002
controls
[34]
Case series with
concurrent
controls
All men with a first bilateral
vasectomy between 1996 and 2000
Excluded: vas impossible to expose
due to technical difficulties (n =7,
0.2%)
O: 1,165 / 1,721
C: 1,453 / 2,040
O: Family planning
clinic in a tertiary
care hospital
(n=1086) and office
(n=635)
C: Office
O: TC (10 mm) + one
Hemoclip on prostatic end + FI
on open testicular end +
Excision (10 mm)
O: July 1996 to November
2000 (n=1,086)
October 1999 to November
2000 (n=635)
C: July 1996 to October
1999
NSV
O: TC (10 mm) + FI on
prostatic end + Open testicular
end + Excision (10 mm)
(n=151), otherwise no excision
C: Ligation with 2 Hemoclips
per vas + Excision (10 mm)
*Number of subjects analysed / total number of subjects enrolled in the study.
O: Open-ended, C: Close-ended, TC: thermal cautery, EC: electro-cautery, FI: fascial interposition, FB: folding back, NSV: no-scalpel vasectomy.
All performed by or
under the supervision
of (1/3 of hospital
cases) one general
practitioner
One general
practitioner
Table 24. Outcome measures of studies comparing vas occlusion techniques with and without leaving the testicular end open
Authors and
Year of
Publication
Shapiro and Silber
Effectiveness
Data
Collection
Timing of SA
1994 [32]
Method of
Follow-up
Main Outcome Measures
No number, motility, nor
time specified
Prospective
Unspecified
Examination at 1
week and then at
monthly
intervals
Granuloma, pain , epididymitis
Retrospective
15 ejaculations
post vasectomy
After 15 ejaculations. If
motile sperm, repeat SA 2
weeks later and at 3 and 5
months.
Motile sperm after 5
months. No number
specified
N/A
N/A
N/A
Complications unspecified in the closeended group
Retrospective
1 year
Unspecified
No number, motility, nor
time specified
Retrospective
1 year
Spontaneous
medical
consultations
Granuloma: Nodule or cyst at the point of
interruption of the vas after the immediate
postoperative tenderness had subsided,
painful to pressure or during ejaculation;
Epididymitis: Tender swelling of all or
part of the epididymis tender lumps in it,
whether solid or cystic, or complaints of
orchialgia in the absence of any detectable
abnormality; cutaneous fistula
Retrospective
Unspecified but
variable
2, 4 and 12 months
postoperatively
No number, motility, nor
time specified
Retrospective
Unspecified
Spontaneous
medical
consultations
Epididymitis: Pain and tenderness of the
testicle on one side.
Follow-up visits
every six months
Bleeding, infection, stasis
1992 [14]
Li et al.
Definition of Failure
Length of
Follow-up
After 15 ejaculations then
monthly even after
azoospermia
1986 [13]
Moss
Data Collection
Unspecified but
variable
1983 [48]
Errey and Edwards
Post-vasectomy Semen Analysis (SA)
Prospective
1979 [15]
Goldstein
Length of
Follow-up
Complications
Prospective
2 years
6 months intervals until 2
years post vasectomy
Presence of sperm two years Prospective
after vasectomy
2 years
Hematomas: mass in the scrotum
Table 24. Outcome measures of studies comparing vas occlusion techniques with and without leaving the testicular end open (continued)
Authors and
Year of
Publication
Labrecque et al.
Effectiveness
Data
Collection
Retrospective
1998 [33]
Length of
Follow-up
At least 4
months but
variable
Complications
Post-vasectomy Semen Analysis (SA)
Timing of SA
3 months
Data Collection
Definition of Failure
Early recanalization: motile
sperm after 3 SA or 6
months, or second SA with
increasing number of motile
sperm
Length of
Follow-up
Method of
Follow-up
Retrospective
At least 4
months but
variable
Spontaneous
medical
consultations
Granuloma (painful lump at the surgical
site), vasi-orchi-epididymitis (swelling
and pain without infection signs),
hematomas (lump at the surgical site
within few hours after surgery), infection
(any prescription of antibiotics), pain (no
diagnostic otherwise), non infectious
painful syndrome (granuloma, vasi-orchiepididymitis and pain combined)
Retrospective
At least 4
months but
variable
Spontaneous
medical
consultations
Surgical (hematomas with or without
infection, and infection - defined as any
antibiotics prescribed), non-infectious
pain (painful granuloma, vasitis/orchiepididymitis, and pain with no specific
diagnosis), other (such as hemospermia,
sexual dysfunction, pain localized at the
wound, isolated scrotal ecchymosis)
Late recanalization:
pregnancy and reappearance
of motile sperm
Labrecque et al.
2002 controls
Retrospective
At least 4
months but
variable
[34]
SA: semen analysis, N/A: not applicable.
2 to 3 months then every 6
weeks until success or
failure
Possible failure: Last SA
showing any motile sperm
or last 2 SA with 1x109/L
non-motile sperm, and last
SA done >91 days postvasectomy, and not
classified as confirmed
failure. Confirmed failure: 3
SA showing any motile
sperm, or 2 SA with
1x109/L sperm with any
motility, and last SA done
>91 days post-vasectomy;
or last SA done >182 days
post-vasectomy showing
1x109/L sperm with any
motility.
Main Outcome Measures
No
?
Yes
Yes
No
?
No
No
Yes
Goldstein
1983 [48]
3
391
0.06
?
No
?
Yes
?
No
?
No
Yes
?
?
?
No
?
Errey and
Edwards
3
8197
1.0
?
No
Yes
Yes
Yes
Yes
?
Yes
No
?
?
?
No
?
Yes
No
No
3
6220
1.0/
?
No
?
Yes
No
Yes
?
No
No
?
Yes
Yes
No
?
Yes
No
No
Yes
No
No
Yes
No
Yes
No
Yes
?
Yes
Yes
Yes
O: 89%
No
No
Yes
Global Assessment
No
Follow-up Rate*
Systematically
Performed in All
Men
?
Adequate
Assessment*
Blinded
No
At the Same Time
Explicit Criteria
Yes
Adequate
Assessment*
No
Sample Size
No
Follow-up
Yes
Provider
?
Setting
0.33
Study Period
524
Participants
2
Shapiro and
Silber
Power*
Systematically
Performed in All
Men
Follow-up Rate*
Complication Assessment
Blinded
At the Same Time
Effectiveness Assessment
Compliance/
Follow-up rate
Adequate
Comparability*
Explicit Criteria
Comparability
Total
Sample Size
Study Design*
Authors and Year of
Publication
Table 25. Quality assessment of studies comparing vas occlusion techniques with and without leaving the testicular end open
No
?
Low
N/A
N/A
Very Low
No
No
?
Low
No
No
No
?
Very Low
Yes
Yes
No
O: 89%
Moderate
1979 [15]
1986 [13]
Moss
0.58†
1992 [14]
Li et al.
2
2373
0.87
C: 87%
1994 [32]
Labrecque et
al.
3
1223
0.71
Yes
No
No
Yes
No
±
Yes
No
Yes
?
Yes
Yes
Yes
O: 70%
C: 87%
Yes
No
No
No
No
?
Low
No
No
No
No
No
?
Moderate
C: 72%
1998 [33]
Labrecque et
al.
3
3761
0.99
Yes
No
No
Yes
±
Yes
Yes
2002
controls
[34]
*Criterion used for global assessment (see Table 2, Additional file 1).
† power for failure, infection, and hematomas / congestive epidydimitis.
O: Open-ended, C: Close-ended, N/A: not applicable.
Yes
Yes
Yes
Yes
Yes
Yes
O: 68%
C: 71%
Table 26. Results of studies comparing vas occlusion techniques with and without leaving the testicular end open
Authors and
Year of
publication
Shapiro and
Silber
Effectiveness (Failure)
Based on
SA
O: 9 (2.1%)
Based on
Pregnancy
Unspecified
C: 0
1979 [15]
Goldstein
O: 2 (50%)
1983 [48]
C: 1 (0.3%)
O: 1 (0.02%)
Infections
Higher failure risk with
open than with closeended, most with cautery
(7/9)
Unspecified
Significantly higher
failure risk with open
than with close-ended.
Very small sample size
Unspecified
Similar failure risk
P < 0.00005
Errey and
Edwards
Comments
Complications
Hematoma
C: 3 (0.08%)
O: 1 (0.03%)
O: 0 (0%)
1992 [14]
C: 0 (0%)
C: 1 (0.03%)
Similar failure risk
Granuloma
Epididymitis
O: 0
O: 420 (97%)
O:0
C: 1 (1%)
C:4 (4%)
C: 1 (1%)
Others
Total
Only one patient, with
close-ended, had pain
associated with
epididymitis
O: 66 (1.5%)
O: 64 (1.5%)
Fistula
C: 122 (3.2%)
C: 106 (2.7%)
O: 1 (0.02%)
P < 0.001
P < 0.001
C: 1 (0.03%)
O: 2 (0.06%)
O: 2 (0.06%)
O: 6 (2%)
C: 0 (0%)
C: 1 (0.03%)
C: 18 (6%)
Significantly lower risk
of epididymal
congestion and painful
granuloma with openended
Similar risk of
complications but
significantly lower risk of
epididymitis with openended
N=300 in O
and C;
p < 0.05
Li et al.
O: 15 (4.1%)
O: 2 ( 0.5%)
1994 [32]
C: 63 (3.1%)
C: 25 (1.2%)
Labrecque et al.
O: 3 (0.9%)
O: 1 (0.3%)
1998 [33]
C: 13 (2.4%)
C: 2 (0.4%)
Labrecque et al.
2002 controls
O: 3 (0.3%)
[34]
C: 126 (8.7%)
Bleeding:
Similar failure risk but
almost all failures (14/15) O: 7 (1.9%)
with O were without FI
C: 5 (0.2%)
O: 1 (0.3%)
O: 0 (0%)
C: 6 (0.3%)
C: 2 (0.1%)
O:14(3.1%) Painful
C 9 (1.2%) granulomas
Vasi-orchiepididymitis
O: 6 (1.3%)
O: 18 (4.0%)
C 6 (0.8%)
C: 15 (1.9%)
Similar risk of infection
and stasis but higher risk
of complications with
open-ended (all without
FI). Total risk of
(undefined)
complications very low
Non significant
(P = 0.14) lower failure
(early + late) risk with
open-ended.
O: 5 (1.1%)
O: 12 (2.7%)
C: 4 (0.5%)
C: 5 (0.6%)
Significant lower failure
risk with open-ended
O: 5 (0.2%)
O: 2 (0.1%)
O:12(0.7%) O: 14 (0.8%)
O: 47 (2.7%)
Surgical:
C: 26 (1.5%)
C: 5 (0.2%)
C:11(0.5%) C: 20 (1.0%)
C: 43 (2.1%)
O: 28 (1.6%)
P < 0.0001
O: 55 (12.3%) Higher risk of painful
granulomas, vasi-orchiC: 39 (5%)
epididymitis, and pain
P < 0.0001
with open-ended
C: 10 (0.5%)
P = 0.0005
Non infectious pain
O: 71 (4.1%)
C: 72 (3.5%)
P = 0.34
SA: semen analysis, O: open-ended, C: close-ended.
Comments
Complications with
close-ended unspecified
1986 [13]
Moss
Pain
Similar risk of non
infectious postvasectomy pain but
higher risk of surgical
complications
(hematomas) with openended