NCT03860805

SALpingectomy for STERilization (SALSTER)

SALpingectomy for STERilization (SALSTER); a Randomized Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 900 (estimated)
• Sponsor: Göteborg University · Academic / Other
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The SALSTER study is a register-based randomized clinical trial (R-RCT) that examines if laparoscopic salpingectomy instead of tubal ligation, as a contraceptive method, has no increased risk for complications and has no negative impact on ovarian function.

Detailed description

SALSTER Study In the last years, the management of Fallopian tubes in benign surgery has drawn a lot of attention due to rising evidence showing that some aggressive forms of ovarian cancer may originate from the distal Fallopian tubes. Concerns were raised about the implications of salpingectomy to surgical outcome and function of the ovaries. The SALSTER study attempts to evaluate the effect of salpingectomy, in regards to surgical outcomes and ovarian function, in women seeking permanent contraception with tubal ligation. The SALSTER study is a register-based randomized clinical trial (R-RCT) that examines if laparoscopic salpingectomy instead of tubal ligation, as a contraceptive method, has no increased risk for complications and has no negative impact on ovarian function. Complications will be assessed primarily at eight weeks post-surgery according to the Clavien-Dindo classification and the existing complications questionnaires in the Swedish National Quality Register of Gynecological Surgery (GynOp). Ovarian function will be primarily assessed by determining the age of natural menopause, measured through questionnaires on bleeding pattern in GynOp every other year. Approximately 900 patients will be recruited. In a subset of patients, the difference in Anti-Müllerian Hormone (AMH) levels from the time of surgery and 1-year after surgery will be compared between the groups. Approximately 180 patients will be recruited. The study is expected to start in the beginning of 2019 and the first results are expected in 2021.

Conditions

• Sterilization Tubal
• Salpingectomy
• Laparoscopy
• Ovarian Reserve

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic tubal ligation	Laparoscopic tubal ligation
PROCEDURE	Laparoscopic bilateral salpingectomy	Laparoscopic bilateral salpingectomy

Timeline

• Start date: 2019-04-03
• Primary completion: 2043-04-01
• Completion: 2050-12-31
• First posted: 2019-03-04
• Last updated: 2025-01-17

Locations

1 site across 1 country: Sweden