A large randomized controlled trial in Sweden found that laparoscopic salpingectomy for sterilization was noninferior to tubal occlusion when tracking complications for up to 8 weeks postoperatively.

The SALSTER trial, findings of which were published in The Lancet Regional Health - Europe, provided evidence on the safety of performing opportunistic salpingectomy during laparoscopic sterilization procedures.

The sterilization rate in Sweden in 2019 was 102 of 100,000 women aged 20 to 49 years, with laparoscopic tubal coagulation being the predominant technique before the study.

Methods

SALSTER was a nationwide, register-based, randomized, noninferiority trial conducted across 41 gynecological departments in Sweden. Women aged < 50 years scheduled for laparoscopic sterilization were randomized 1:1 to undergo either salpingectomy or tubal occlusion.

Between April 4, 2019, and March 31, 2023, 1,066 women were randomized: 539 to undergo salpingectomy and 527 to undergo tubal occlusion. The per-protocol population consisted of 473 women who underwent salpingectomy and 499 who underwent tubal occlusion.

Baseline characteristics of participants included:

• Mean age: 36.1 years
• Mean body mass index (BMI): 26.8 kg/m²
• ASA classification: 71% ASA I, 28% ASA II, 1% ASA III-V
• Prior receipt of abdominopelvic surgery: 32% of participants
• Caesarean section history: 20% of participants.

The primary outcome was any complication up to 8 weeks postoperatively, as reported in the Swedish National Quality Register of Gynaecological Surgery through physician assessment of patient questionnaires, medical records, and personal contact.

Statistical methods included the use of generalized estimation equation with logistic link function, multiple imputation for missing data (30 imputed datasets), and mixed effects models for analyzing operative time.

Key Findings

The reported complication rates were 8.1% among patients undergoing salpingectomy vs 6.2% among those undergoing tubal occlusion; the risk difference was 1.9 percentage points (95% confidence interval [CI] = –1.4 to 5.3), the noninferiority margin was 10 percentage points, and the operative time was 44 minutes for salpingectomy vs 29 minutes for tubal occlusion.

Further Results

In the per-protocol analysis based on imputed data, complications occurred in 38.5 of 473 (8.1%) women after salpingectomy and 31.0 of 499 (6.2%) women after tubal occlusion. The risk difference of 1.9 percentage points (95% CI = –1.4 to 5.3) did not exceed the predefined noninferiority margin of 10 percentage points.

Complication details (Clavien-Dindo classification):

• Grade 1: 6.4% for salpingectomy vs 4.7% for tubal occlusion
• Grade 2: 1.3% for both groups
• Grade 3a: 0.2% for salpingectomy vs < 0.1% for tubal occlusion
• Grade 3b: 0.2% for both groups
• No Grade 4 or 5 complications were reported.

Secondary outcomes revealed:

• A rate of severe complications of 0.2% in both groups.
• A mean perioperative blood loss of 6.7 mL for salpingectomy vs 4.1 mL for tubal occlusion (P < .0001).
• A mean operative time of 44.6 minutes for salpingectomy vs 29.3 minutes for tubal occlusion (P < .0001).
• A similar length of hospitalization for the two procedures (odds ratio = 0.84; 95% CI = 0.25-2.78).

Sixty percent of all surgical cases used a main trocar >10 mm. In the salpingectomy procedures, 85% used at least two accessory trocars; 54% used bipolar coagulation and 44% used an advanced bipolar sealing device. In the tubal occlusion procedures, 80% used one accessory trocar; the most common technique was bipolar coagulation. Fascia suturing took place after 71% of the salpingectomies and after 60% of the tubal occlusions.

Sensitivity analyses found:

• Unadjusted analysis (Farrington-Manning method): Risk difference = 1.9 pp (95% CI = –1.4 to 5.4)
• Complete case analysis with GEE adjustment: Risk difference = 2.1 pp (95% CI = –1.3 to 5.4).

Comparison with background population:

• Complications up to 8 weeks postoperatively: 6.8% (101 of 1,488) in the background population
• Median BMI was 0.6 units higher in the Full Analysis Set (FAS) compared to the background population
• Ex-smokers were more common in the FAS, but current smokers were similarly frequent
• Diabetes was more often reported in the background population.

Participant flow:

• Discontinuation rates were 7% (n=40) in salpingectomy group and 3.5% (n=18) in tubal occlusion group
• Protocol deviations occurred in 26 of 499 participants in the salpingectomy group and in 10 of 509 in the tubal occlusion group.

Conclusions

The authors concluded that laparoscopic salpingectomy for sterilization was noninferior to tubal occlusion regarding complication rates up to 8 weeks postoperatively. They noted that while short-term safety of salpingectomy had been confirmed, long-term effects on ovarian function, early menopause, and ovarian cancer incidence still needed to be addressed.

This study provided data to inform clinical practice and patient counseling regarding laparoscopic sterilization techniques. Future research from the SALSTER trial will examine the impact of salpingectomy on menopausal age, as well as contribute data to estimate the efficacy of opportunistic salpingectomy for ovarian cancer prevention.

The authors declared having no competing interests.