SALpingectomy for STERilization (SALSTER)

Göteborg University

Status: Active, not recruiting

Conditions: Laparoscopy; Salpingectomy; Sterilization Tubal; Ovarian Reserve

Treatments: Procedure: Laparoscopic bilateral salpingectomy; Procedure: Laparoscopic tubal ligation

Study type: Interventional

Funder types: Other

Identifiers

NCT03860805

316-18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 900 estimated patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Planned laparoscopic sterilization
• Willing to be randomized

Exclusion criteria

• Women older than 49
• Not understanding the oral or written study information
• Previous malignancy involving radiation, chemotherapy or endocrine treatment affecting ovarian function

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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900 participants in 2 patient groups

Laparoscopic tubal ligation

Active Comparator group

Description:

Patients who seek for surgical permanent contraception and randomized to laparoscopic tubal ligation

Treatment:

Procedure: Laparoscopic tubal ligation

Laparoscopic bilateral salpingectomy

Active Comparator group

Description:

Patients who seek for surgical permanent contraception and randomized to laparoscopic bilateral salpingectomy

Treatment:

Procedure: Laparoscopic bilateral salpingectomy