Keywords
female - sterilization - salpingectomy - laparoscopic surgery - ovarian cancer
Palavras-chave
mulher - esterilização - salpingectomia - cirurgia laparoscópica - câncer do ovário
Introduction
Female sterilization includes a number of different procedures and techniques that
provide permanent contraception for women. Methods of female sterilization include
tubal occlusion, partial salpingectomy, and total salpingectomy. The only indication
for female permanent contraception is patients' preference to have a permanent method
of contraception for pregnancy prevention.[1]
Female permanent contraception can be performed using several different procedures
and techniques that prevent pregnancy by occluding or removing the fallopian tubes.[1] Laparoscopy is the most common surgical approach.[1] Tubal sterilization by cutting ant tying the fallopian tube, or using electric current,
clips or rings, is an effective method of contraception.[2] Salpingectomy is the complete removal of the fallopian tubes.
Major complications are considered to be the need for any surgery such as unintentional
laparotomy, perforate viscera repair, rupture large vessels, loss of blood greater
than 500 ml, blood transfusion needs, febrile morbidity, or potentially fatal events.
Minor complications include uterine lesions, small vessel injuries, paralytic ileus,
wound dehiscence, and urinary tract infections.[3]
The overall complication rate of laparoscopic sterilization is low. The rate of major
complications observed in a prospective cohort study was 1.6%, and performing an unintentional
laparotomy and rehospitalization were the most reported complications. The rate of
minor complications was 0.26%, and uterine injury was the most frequent complication.[3] Estimates of failure rates for tubal section were less than 5 pregnancies per 1000
procedures in the first-year poststerilization.[2]
The American College of Obstetricians and Gynecologists (ACOG) and the American Cancer
Association (ACS) recommend opportunistic salpingectomy for primary prevention of
epithelial carcinoma of the fallopian tube, ovary, or peritoneum in a woman undergoing
pelvic surgery for another indication, including desire of permanent contraception.[4]
[5] According some authors, women who had undergone a tubal ligation or a bilateral
salpingectomy had a reduction risk to develop ovarian cancer, 24 and 65%, respectively,
when compared with women who did not have performed this procedure. Moreover, salpingectomy
offers a 100% efficacy compared with other methods.[4]
[6]
Because salpingectomy has been associated with a concern over its potentially damaging
effect on the ovarian reserve, during many years procedures like tubal occlusion were
preferred. However, recent studies showed that bilateral salpingectomy did not cause
any decline in serum Anti-Müllerian Hormone concentration, despite the expected increase
in damage to the ovarian blood supply.[4]
[7]
Methods
This is a retrospective cohort study of women who underwent laparoscopic surgical
sterilization, performed at the Ambulatory Surgical Center in the Alto Minho Local
Healthcare Unit (ULSAM), Viana do Castelo, Portugal, during January of 2016 and December
of 2018. Inclusion criteria were all women undergoing a laparoscopic surgical sterilization
during this time. The exclusion criteria were performing more than one surgical procedure
for sterilization, and loss of follow-up.
This study was conducted with the approval of the Ethics Committee of ULSAM, with
no need for Institutional Review Board approval.
Patients' charts were reviewed to obtain demographic information (age, body mass index,
smoking status, and parity), presence of medical and surgical comorbidities (endometriosis,
inflammatory pelvic disease, and abdominal or pelvic surgery), level of surgeon (resident
vs. attending), type of procedure, number of abdominal ports, surgical time, acute,
short, and long-term complications, and effectiveness of procedure. A number was assigned
to each patient, in order to maintain data confidentiality.
The laparoscopic approach in ULSAM is the salpingectomy using the bipolar Maryland
forceps for cauterization, followed by scissors for transection. Patients who underwent
other procedures were excluded. Surgical time was defined from incision to closure.
Acute complications (during the procedure or prior to leaving the ambulatory center)
included hemorrhage, pain, needs of hospitalization, uterine perforation, and complications
related to insufflation of gas. Short-term complications (within 24 hours postdischarge)
were assessed through telephone contact, namely pain, fever, suture bleeding, nausea
and vomiting, and normal intestinal function. Long-term complications were assessed
during standard of care, postoperative visits, and urgency care visits, where infection,
pain requiring additional visits, and readmission to the hospital were searched.
Continuous variables were described using median and standard deviation, and categorical
variables using frequencies. Continuous variables were compared between groups using
the Mann-Withney test, and dichotomous variables using the Fisher exact test or the
Chi-square test, as appropriate. A linear regression and a logistical regression were
performed to evaluate possible confounding or adjustments factors. The odds ratio
(OR) and 95% confidence interval (CI) were calculated. Statistical analyses were performed
with the the Statistical Package Social Sciences (SPSS, IBM Corp., Armonk, NY, USA)
version 23. Statistical significance was defined as p-values < 0.05.
Results
The study population includes all women undergoing laparoscopic sterilization in the
Ambulatory Surgery Unit (n = 221). Procedures included 79 (35.7%) salpingectomies and 142 (64.3%) tubal occlusions.
No significant differences were verified between the median of age (38 vs. 38 years,
p = 0.86) and median of body mass index (BMI) of the two groups (26.30 vs. 26.23 kg/m2, p = 0.50). In this sample, only one woman had a documented history of endometriosis.
The most used contraceptive method before surgery was combined pill (n = 81; 36.7%) and the least was natural family planning (n = 3; 1,4%). In the study population, 34.2% of women (n = 75) had a history of abdominal or pelvic surgery. Patient characteristics for the
221 women are presented in [Table 1].
Table 1
Demographics and medical history of women submitted to sterilization from January
of 2016 to December of 2018
|
All
|
Electrocoagulation and tubal section
|
Salpingectomy
|
p-value
|
|
Median (quartiles) / (frequencies, %)
|
n = 142
|
n = 79
|
|
|
Age (years)
|
37.89 (27–46%)
|
37.7
|
38.1
|
0.625
|
|
BMI (kg/m2)
|
25.96 (17.2–40.2%)
|
25.8
|
26.1
|
0.609
|
|
Gravidity
|
|
|
|
|
|
1
|
32 (14.5%)
|
17
|
15
|
|
|
2
|
94 (42.5%)
|
66
|
28
|
|
|
≥ 3
|
95 (43%)
|
59
|
36
|
|
|
Parity
|
|
|
|
|
|
1
|
41 (18.6%)
|
24
|
17
|
|
|
2
|
117 (52.9%)
|
83
|
34
|
|
|
≥ 3
|
63 (28.5%)
|
35
|
28
|
|
|
Tobacco use
|
19 (8.6%)
|
13
|
6
|
0.449
|
|
Medical conditions
|
|
|
|
|
|
Diabetes
|
2 (1%)
|
0
|
2
|
0.296
|
|
Hypertension
|
20 (9%)
|
14
|
6
|
0.394
|
|
Human Immunodeficiency Virus
|
1 (0.5%)
|
0
|
1
|
0.276
|
|
Thyroid Pathology
|
13 (5.9%)
|
7
|
6
|
0.291
|
|
Thrombosis history
|
8 (3.6%)
|
6
|
2
|
0.421
|
|
Gynecology history
|
|
|
|
|
|
Endometriosis
|
1 (0.5%)
|
0
|
1
|
0.354
|
|
Inflammatory pelvic disease
|
3 (1.4%)
|
1
|
2
|
0.292
|
|
Prior abdominal or pelvic surgery
|
75 (33.9%)
|
49
|
26
|
0.88
|
Abbreviation: BMI, body mass index.
In this study, 73.3% (n = 162) of procedures were performed by resident physicians, where 40% (n = 33) of those were salpingectomies. Average surgical times were 10.5 minutes longer
for salpingectomy compared to tubal occlusion method (52.7 vs. 42.2 min, respectively;
p < 0.001; 95% CI = 6.5–13.6), after control for BMI, prior abdominal or pelvic surgery
and procedure realized by a resident ([Table 2]).
Table 2
Characteristics of procedure of groups with respective p-values
|
Electrocoagulation and tubal section
|
Salpingectomy
|
p-value
|
|
n = 142
|
n = 79
|
|
|
Resident surgeon
|
107 (75.3%)
|
55 (69.6%)
|
0.35
|
|
Surgery time (min)
|
42.2
|
52.7
|
< 0.001
|
|
Number of ports
|
2.08
|
3.01
|
0.033
|
|
Acute complications
|
4 (2.8%)
|
0 (0%)
|
–
|
|
Needs of hospitalization
|
2 (0.9%)
|
0 (0%)
|
–
|
|
Long-term complications
|
4 (2.8%)
|
2 (2.5%)
|
0.64
|
|
Efficacy
|
141 (99.3%)
|
79 (100%)
|
0.64
|
Notes:
p-values in bold were statically significant.
Regarding complications, 4 acute complications occurred in the tubal occlusion group
(2 mesosalpinx hemorrhages that required an overnight in the Gynecology Department,
1 subcutaneous emphysema, and 1 uterus perforation), with no registered acute complications
in the salpingectomy group (2.8 vs. 0%). Furthermore, 24 hours after surgery, the
short-term complications were assessed by telephone contact (n = 175); this group included 68 (38.9%) salpingectomy and 107 (61.1%) tubal occlusion
procedures. There were no differences between short-term complications in both groups
([Table 3]).
Table 3
Postoperative outcomes according to type of procedure
|
Electrocoagulation and tubal section
|
Salpingectomy
|
p-value
|
|
n = 107
|
n = 68
|
|
|
Fever
|
0 (0%)
|
0 (0%)
|
–
|
|
Nausea and vomiting
|
0 (0%)
|
1 (1.5%)
|
–
|
|
Suture bleeding
|
3 (2.8%)
|
0 (0%)
|
–
|
|
Normal intestinal function
|
45 (42.1%)
|
22 (32.4%)
|
0.198
|
|
Pain (> 5)*
|
3 (2.8%)
|
4 (6%)
|
0.295
|
Notes: * Pain was rated on an increasing analog scale from 1 to 9.
When evaluating postoperative pain, no significant differences were registered between
both groups, even after controlling for number of ports, surgery time, level of the
surgeon, and prior abdominal or pelvic surgeries. Long-term complications for the
salpingectomy group included 1 wound infection requiring oral antibiotics and 1 wound
dehiscence (without need for reintervention). In the tubal occlusion group, it was
registered 2 cases of wound infection, and 1 of wound dehiscence (without need of
reintervention), but without significant differences between the groups (2.5% vs.
2.8%, p = 0.64). Procedure efficacy didn't show significant differences between the salpingectomy
and tubal occlusion groups (100 vs. 99.3%, respectively; p = 0.64) with 1 pregnancy registered in the tubal occlusion group.
Discussion
This study suggests that salpingectomy in sterilized procedure is a safe procedure.
No safety concerns were found (acute, short or long-term complications) comparing
laparoscopic salpingectomy and tubal occlusion for women sterilization, as suggested
in previous studies.[4]
[8]
[9] This study showed a higher rate of acute complications (0 vs. 2.8%) with an increase
of hospitalization (0 vs. 0.9%) in the tubal occlusion group compared with the salpingectomy
group; however, there was no statistically significant difference between groups.
Although the literature describes a higher risk of surgical complications in women
with diabetes, obesity, and previous abdominal or pelvic surgeries, this was not confirmed
in our sample.
The surgical time of salpingectomy is slightly longer than the tubal occlusion method,
without significant differences of complications rates.[4] The average surgical time was 10.5 min higher in the salpingectomy group, when compared
with the tubal occlusion group. These results support the findings of Westberg et
al.[8] (additional time of 6 minutes) and Hanley et al.[10] (additional time of 16 min). After control for BMI, prior abdominal or pelvic surgeries,
and procedure performed by a resident physician, the time of surgery was defined by
the type of procedure chosen. This data is in accordance with Wong et al.,[11] who showed that salpingectomy can be effective regardless of the surgeon's level.
In this study, the efficacy of tubal occlusion was 99.3% (with 1 case of pregnancy
during the first year after the procedure, 7 per 1,000 procedures) and 100% in salpingectomy.
According to the Collaborative Review of Sterilization (CREST) study, the cumulative
10-year probability of pregnancy following tubal ligation was 18.5 per 1,000 procedures,
and 7.5 per 1,000 with unipolar coagulation and postpartum partial salpingectomy.[11] Young age at the time of sterilization has been determined to be the main predictor
of failure.[12]
The ovarian function was not assessed in this study; however, in a systematic review,
Mohamed et al.[7] showed that radical salpingectomy doesn't seem to interfere with the ovarian reserve
in the short term. However, the long-term effect remains uncertain, predicting a possible
concomitant damage to the ovarian blood supply.
According to ACOG and ACS, salpingectomy offers the opportunity to significantly decrease
the risk of ovarian cancer.[4]
[5] Women with the BRCA-1 mutation are also found to have a risk reduction of ovarian
cancer.[9] Wong et al.[11] showed that for sterilization, salpingectomy is more costly than tubal occlusion,
but more effective. Kwon et al.,[13] using a statistic model designed to determine cost-effectiveness of opportunistic
salpingectomy, showed that salpingectomy had to provide a relative increase in risk
reduction of 25% over tubal ligation, and according to the authors' model, there is
a relative risk reduction of 29.2% in ovarian cancer cases with the use of salpingectomy
versus tubal ligation.
Some limitations of this study should be noted, such as its retrospective nature,
the relatively small sample size, the fact that some patients could be followed up
and/or admitted in a different hospital, and the short follow-up time to assess procedure
efficacy. However, this is an original study, and there are few studies in this area
which study this important question.
Conclusion
Our study shows that the salpingectomy procedure is possible and safe at the Ambulatory
Surgery Unit, preventing tubal torsion surgery, hydrosalpinx, or ectopic pregnancy.
An improvement of surgical time could be achieved with more training and experience
of surgeons in laparoscopy and salpingectomy procedures.
