Effectiveness of laparoscopic tubal anastomosis in tubal ligation patients, A retrospective study

doi:10.21203/rs.3.rs-1743694/v1

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Effectiveness of laparoscopic tubal anastomosis in tubal ligation patients, A retrospective study

https://doi.org/10.21203/rs.3.rs-1743694/v1

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Objective

To evaluate the pregnancy outcome after laparoscopic tubal anastomosis and to analyze the factors that may affect the pregnancy outcome.

Methods

This study was a retrospective analysis of pregnancy outcomes in 82 patients with a history of tubal sterilization treated with laparoscopic tubal anastomosis at the Lanzhou University Second Hospital Reproductive Medicine from July 2017 to December 2021. The primary outcomes were intrauterine pregnancy, ectopic pregnancy, miscarriage. We also examined relevant factors that may influence pregnancy status.

Results

The cumulative clinical pregnancy rate for all patients was 52/81 (63.61%). The distribution of pregnancy outcomes for the whole group was as follows: intrauterine pregnancy rate, 49/81 (59.75%), ectopic pregnancy rate, 3/82 (3.66%) and miscarriage rate, 5/81 (6.10%). In the multivariate model, age, pelvic adhesions, and endometrial polyps may be the main prognostic factors.

Conclusion

Laparoscopic tubal anastomosis is an effective treatment for patients with tubal-related infertility, especially for women under 40 years.

correlated factors

pregnancy outcome

laparoscopic

tubal anastomosis

Contraception after pregnancy is available in various forms¹, however, tubal sterilization remains one of the most common methods of contraception worldwide and women who have given birth to two children are more likely to undergo tubal ligation. Many reasons, such as the loss of a child or remarriage after divorce, force them to conceive again ². Either the surgical approach or IVF-ET can be used as an alternative treatment for these patients^3,4.

Tubal anastomosis is a cost-effective procedure that reconstructs the structure and function of the fallopian tubes and is the only way for patients to conceive naturally after tubal ligation^4,5. With advances in in vitro fertilization techniques, the value of tubal anastomosis in tubal occlusion has been challenged⁶. Both tubal anastomosis and IVF have advantages and disadvantages⁷. A successful tubal anastomosis allows spontaneous conception during every ovulation cycle. However, there are disadvantages to tubal surgery, including the risks of the procedure (general anesthesia, intraoperative and postoperative) and the high incidence of postoperative EP. For older women, the waiting period until conception can be long, which can pose a disadvantage. Although the time required to conceive through IVF is relatively short and minimally invasive, the majority of patients who undergo tubal anastomosis are low-income and lack the financial resources to undergo IVF because it is expensive. In addition, IVF has some potential complications, including multiple pregnancies and ovarian hyperstimulation syndrome^8,9.

According to our review of the English medical literature, relatively few studies have examined tubal anastomosis effectiveness, and most have a small sample size ^10–14. Currently, most studies focus on the baseline data and pregnancy outcomes of patients with a history of tubal sterilization, The intraoperative conditions and pelvic status have not been considered. In our study, a multivariate analysis was used to identify risk factors for tubal anastomosis prognosis by collecting baseline data and intraoperative conditions of patients.

This study was approved by the Medical Ethics Committee of the Second Hospital of Lanzhou University. The retrospective study included patients with a history of laparoscopic tubal sterilization. All included patients refused in vitro fertilization and requested tubal anastomosis. These procedures were performed at the Lanzhou University Second Hospital Department Reproductive Medicine from July 2017 to December 2021. The patients' ages ranged from 19 to 47 years. A thorough evaluation of the ovarian function of each participant was conducted prior to surgery, including measuring ovarian size, follicle counts on ultrasound, and FSH levels. There were no contraindications to surgery.

All participants agreed to use their personal data anonymously. The exclusion criteria were as follows. 1) Either partner had a disease unsuitable for pregnancy, such as severe heart disease, diabetes, etc.; 2) Bilateral fusion of the fallopian tubes with bilateral peritoneum, without normal structures, which prevented surgical treatment; 3). Male partners with abnormal semen analysis.

Every participant underwent hysteroscopy as part of routine infertility evaluations during the first half of the menstrual cycle. An intraoperative removal of identifiable endometrial polyps was done simultaneously, and histopathological examination was conducted for confirmation. When laparoscopic exploration is performed, adhesions in the pelvis or tubum should be treated first with adhesiolysis. A tubal anastomosis participant's fallopian tubes were normal, the tubal walls were thin and pliable, the luminal mucosa lush, and the tubal umbilicus functioned normally.

We injected diluted methylene blue solution through bilateral syringes to observe the tubal sites through which the solution flowed. Afterwards, the stump tissues at both ends of the tubal were excised. T An absorbable surgical suture is used to stitch the two broken ends of the tubal ampulla with three or four stitches. Subsequently, the tubal serosal layer was sutured simultaneously while avoiding access to the tubal lumen. If the methylene blue solution flows smoothly from the umbilicus of the fallopian tube, patency of the tube is confirmed. The uterus, pelvis, and bilateral ovaries were examined, and any associated lesions were treated appropriately. The most common lesions were caused by endometriosis and tubal or pelvic adhesions. All participants had sexual uterine tubal lavages 1 month after surgery and attempted to become pregnant on their own 3 months afterward.

Medical information including age, body mass index, obstetric history, years of tubal ligation surgical, Surgery related data (anastomosis type, tubal patency, and various complications such as endometrial polyps, mild/moderate endometriosis and pelvic adhesions, uterine fibroids, ovarian cysts) and reproductive outcomes were collected from all participants. The primary outcomes were intrauterine pregnancy (IUP), Ectopic pregnancy(EP), and delivery rates. The presence of serum β-human chorionic gonadotropin (β-hCG) level of 30 mIU/ml and a gestational sac on ultrasonography confirmed pregnancy. During the 24-month follow-up period, each woman was contacted via telephone to assess her pregnancy outcome. Patients were dropped from the study when they failed the procedure, lost contact or delayed their pregnancy plans.

Statistical Analysis

Descriptive variables were transformed into categorical variables and expressed as percentages, while continuous variables were expressed as mean ± SD. Pregnancy rates in different subgroups were assessed with the ꭕ2 test. We divided the patients into non-pregnant and pregnant groups after excluding ectopic pregnancies, and the effects of various variables on fertility were estimated by logistic regression analysis. All analyses were performed using SPSS version 26.0 (IBM Corporation, Armonk, NY, USA). p-Values < 0.05 were defined as statistically significant.

From July 2017 to December 2021, 107 women with a history of tubal sterilization underwent laparoscopic bilateral tubal anastomosis and postoperative tubal evacuation. 26 patients (24.3%) were lost to follow-up. Therefore, 82 patients were included in the analysis. The mean age of the patients was 34.98 years (Table 1). The cumulative pregnancy rate was 52/82 (63.41%), intrauterine pregnancy rate was 49/82 (59.95%) and EP rate was 3/82 (3.66%), and miscarriage rate, 5/82 (6.1%) (Table 2).

In the binary logistic regression analysis, we included age, BMI, Years of tubal ligation, type of anastomosis, endometrial polyps, mild/mild endometriosis, pelvic adhesions, and uterine fibroids were used as the independent variables. IUP was used as the the dependent variable. The baseline characteristics can be seen from Table 3. The modified Hosmer-Lemeshow fit ꭕ2 test was 1.902 (P = 0.592), which indicated a good fit for the multivariate model (P > 0.05). The results showed that age, pelvic adhesions had a significant effect on the total IUP rate in the model. Endometrial polyps may also be an effect on pregnancy outcomes (Table 4).

Previous studies showed that the pregnancy rate of laparoscopy was 31–85% and the rate of ectopic pregnancy observed by laparoscopy was 0–7%¹⁵. The results of our study, which analyzed the pregnancy outcomes of patients after laparoscopic salpingostomy, were consistent with those of previous studies. The cumulative pregnancy rate was 63.41%, intrauterine pregnancy rate was 59.95%, EP rate was 3.66%, and miscarriage rate was 6.1%. For women with tubal factor infertility, assisted reproductive techniques have highly successful. Regardless, tubal reconstruction is less expensive than IVF and offers multiple chances to try spontaneous conception. When choosing between IVF and tubal anastomosis, all factors should be considered.

Female infertility can be due to ovulatory disorders(25%), endometriosis(15%), Pelvic adhesions(12%), Tubal blockage(11%), Other tubal abnormalities(11%), Hyperprolactinemia(7%)¹⁶. In a previous study conducted by Xavier DeYeux concluded that Young age (< 35 years), type of ligature, years of ligation (< 8 years), the anastomosis site and a good length of remaining tube (> 7 cm) are the factors that govern whether tubal patency could be good restoration¹⁵. To identify factors affecting pregnancy outcome after laparoscopic tubal anastomosis, baseline data, intraoperative conditions and pelvic status of patients undergoing laparoscopic tubal anastomosis were collected. After multivariate analysis, we found that age (> 40 years), pelvic adhesions, and endometrial polyps may independent risk factors for pregnancy after laparoscopic tubal anastomosis. However, the type of anastomosis, BMI, Years of tubal ligation, Fibroid, oophoritic cyst, Endometriosis did not differ significantly between the two groups.

Age is the strongest prognostic factor affecting the chances of conception after reversal of female sterilization. Data from our study are consistent with those from previous studies. A previous study concluded that tubal anastomosis was the most cost-effective method for most women less than 41 years, while IVF was the most cost-effective method for the oldest women ≥ 41 years of age wishing to have children after tubal ligation¹⁷. For women over 40 years of age, oocyte quality gradually declines over time and is accompanied by a lower pregnancy rate ^18,19. In our study, for women trying to conceive after tubal ligation, the pregnancy rate after tubal anastomosis was higher for women under 40 years. Currently, the best options for sterilized women over 40 years of age are IVF. Further research is needed to determine a more accurate age cutoff.

In our study, we found lower pregnancy rate in patients with pelvic adhesion. The term of pelvic adhesions refers to tubal adhesions, ovarian adhesions, and oviduct adhesions in pelvic tissues due to inflammation²⁰. A cross-sectional study was conducted to assess the incidence and location of pelvic adhesions in patients with unexplained infertility after caesarean section. In the above study, the data led us to conclude that pelvic adhesions are common in infertile patients with unexplained causes of infertility after caesarean section²¹. Pelvic adhesions can damage the structure and function of fallopian tubes, which will lead to infertility.

In our study, we also found lower pregnancy rate in patients with endometrial polyps although the difference was not statistically significant. This may be due to the small sample size. Endometrial polyps are common in infertile women, and the prevalence rate is as high as 32%²². In fact, polyps are associated with an increased likelihood of abnormal molecular expression in the endometrium, which will impair implantation and early embryonic development. Potential mechanisms by which endometrial polyps may adversely affect fertility include mechanical interference and the release of molecules that adversely affect sperm transport or embryo implantation. There exists evidence that increased levels of aromatase, decreased levels of HOXA-10 and HOXA-11 mRNA will negatively affect endometrial receptivity ^23,24.

In summary, in spite of advances in IVF, reproductive surgery remains a viable option, especially for women under the age of 40. When choosing between IVF and tubal anastomosis, all factors should be considered.

This study has several advantages. First, regular updating of the pregnancy status of the patients during follow-up made our data more accurate. Second, All patients were operated by the same surgeon, thereby removing the influence of the surgeon's ability to operate on pregnancy outcomes. However, our study also had limitations. First, study participants recruited from only one location were subject to selection bias. Second, this retrospective study involved 82 cases, and the relatively small sample size limited the statistical power of this study and also limited our ability to do further predictive modeling of pregnancy outcomes. A multicenter prospective trial is needed to validate our findings.

Conflicts of interest

The authors have no conflict of interest.

Funding

This work was supported by the National Natural Science Foundation of China (project number:81960515).

Author Contributions

FW: designed the study

ND: Manuscript writing

JZ: data analysis

PLW: Data collection and responsible for follow-up

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Table 1 Baseline characteristics of all patient who underwent laparoscopic anastomosis^a

Characteristics/parameters

Frequency

Age, years

≤40(n, %)

>40(n, %)

BMI

Education

high school and below(n, %)

university and above (n, %)

During of tubal ligation, years

Parity

Tubal ligation site（L）

Isthmus(n, %)

Isthmus-ampulla(n, %)

ampulla(n, %)

Tubal ligation site（R）

Isthmus(n, %)

Isthmus-ampulla(n, %)

ampulla(n, %)

Basal FSH(IU/L)

Basal LH(IU/L)

LH/FSH ratio

Basal T(ng/dL)

Glucose(mmol/L)

34.98±5.37

70(85.4)

12(14.6)

23.16±3.17

81(98.8)

1(1.2)

9.34±3.73

2.38±0.76

31(37.8)

37(45.1)

14(17.1)

24(29.2)

40(48,8)

18(22.0)

7.61±2.77

4.49±1.97

0.65±0.34

24.06±12.41

4.99±0.55

Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by the square of height in meters);L, left, R:right, FSH, follicle stimulating hormone, LH, luteinizing hormone.

^a Data are expressed as mean ± SD or as percentage

Table 2 Results of the reversal procedure^a

Parameters/outcome

Frequency

Overall pregnancy rate (n, %)

Intrauterine pregnancy rate (n, %)

Abortion rate(n, %)

Ectopic pregnancy rate (n, %)

52(63.41)

49(59.75)

5(6.10)

3(3.66)

^a Data are expressed as percentage

Table 3 Basic characteristics of patients after tubal anastomosis in the intrauterine pregnancy and non-pregnancy^a

characteristics

Intrauterine pregnancy（n=49）

Non-pregnangy (n=30)

p-Value

Age

BMI

Education

high school and below(n, %)

university and above (n, %)

During of tubal ligation, years

Parity

Tubal ligation site（L）

Isthmus(n, %)

Isthmus-ampulla(n, %)

ampulla(n, %)

Tubal ligation site（R）

Isthmus(n, %)

Isthmus-ampulla(n, %)

ampulla(n, %)

Basal FSH(IU/L)

Basal LH(IU/L)

Basal T(ng/dL)

Glucose(mmol/L)

34.53±4.62

23.17±3.29

1(2.2)

48(97.8)

9.33±3.13

2.45±0.82

15(30.6)

26(53.1)

8(16.3)

11(22.4)

29(59.2)

9(18.4)

7.85±2.80

4.44±1.56

20.52±9.86

4.98±0.52

35.70±6.57

23.36±3.08

30(100)

9.27±4.58

2.27±0.79

15(50.0)

10(33.3)

5(16.7)

12(40.0)

10(33.3)

8(26.7)

7.40±2.99

4.26±2.30

29.31±14.59

5.05±0.58

0.356

0.80

0.95

0.332

0.18

0.079

0.663

0.799

0.051

0.625

Table 4 Logistic regression analysis of the influencing factors of intrauterine pregnancy in patients after tubal anastomosis ^a

Predictive factors

Univariate analysis

OR(95%CI) p-Value

Multivariate analysis

OR(95%CI) p-Value^a

Age>40（years）

BMI>24（kg/m²）

Years of tubal ligation

Tubal ligation site(L)

Tubal ligation site(R)

Fibroid

oophoritic cyst

Pelvic adhesion

Endometrial polyps

Endometriosis

4.091(1.11-15.07)

1.667(0.64-4.34)

1.004(0.89-1.14)

1.479(0.76-2.87)

1.204(0.63-2.30)

0.587(0.11-3.12)

0.604(0.04-10.03)

0.3436(0.13-0.86)

0.292(0.08-1.10)

0.695(0.27-1.76)

0.034

0.296

0.944

0.247

0.573

0.532

0.725

0.023

0.069

0.443

4.269(1.09-16.76) 0.038

0.304 (0.11-0.84) 0.021

0.266(0.07-1.08) 0.064

Abbreviations: OR, odds ratio; CI, confidence interval; BMI, body mass index; L, left; R, right.

^aThe modified Hosmer-Lemeshow goodness-of-fit ꭕ2 test statistic was 1.902 (P = 0.592)

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Effectiveness of laparoscopic tubal anastomosis in tubal ligation patients, A retrospective study

Status:

Version 1

Abstract

Objective

Methods

Results

Conclusion

1. Introduction

2. Materials And Methods

3. Results

4. Discussion

Declarations

References

Tables

Status:

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