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Active, not recruiting Not applicable

SALpingectomy for STERilization (SALSTER)

NCT03860805 · tracked via the Priya Life Science Sweden tracker
Phase
Not applicable
Started
2019-04-03
Last updated
2025-01-17

Condition(s) studied

Sterilization TubalSalpingectomyLaparoscopyOvarian Reserve

Investigational drug(s) / intervention(s)

Laparoscopic tubal ligationLaparoscopic bilateral salpingectomy

Laparoscopic tubal ligation: Laparoscopic tubal ligation

Laparoscopic bilateral salpingectomy: Laparoscopic bilateral salpingectomy

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
49 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Complications — Eight weeks post-operatively
    Complication according to the Clavien-Dindo classification or specific questions on complications in GynOp Register (Swedish National Quality Register of Gynecological Surgery). Binary data.
  • Age at menopause — Twenty years
    Determined from questionnaires on bleeding pattern in GynOp. Continuous data.

Trial sites (1)

FacilityCityRegionStatus
Sahlgrenska University Hospital Gothenburg Sweden
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03860805 on ClinicalTrials.gov ↗ ← All trials in Sweden