SALpingectomy for STERilization (SALSTER)

Not Applicable

Active, not recruiting

• Conditions: Laparoscopy; Salpingectomy; Ovarian Reserve; Sterilization Tubal

• Registration Number: NCT03860805
• Lead Sponsor: Göteborg University

Brief 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.

Study Timeline

• Study First Submitted: 2018-10-30
• Study First Submitted QC: 2019-03-01
• Study First Posted: 2019-03-04
• Study Start: 2019-04-03
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-17
• Primary Completion: 2043-04
• Study Completion: 2050-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 900

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Severe complications	Eight weeks post-operatively	Complications according to the Clavien-Dindo classification or the specific questions on complications in GynOp. Binary data.
Operative time	At day of surgery	In minutes. Continous data.
Length of hospital stay	Assessment will be done at discharge from hospital after surgery, including a period up to 8 weeks	In Days. Continous data.
Complications according to Clavien-Dindo	One year after surgery	Assessed according to Clavien-Dindo. Binary data.
Age at the start of the perimenopausal state	Up to 55 years of age	Assessed through questionnaires in GynOp. Continous data.
Use of hormone replacement therapy at any time during follow-up	Up to 55 years of age	Either an answer yes to question in GynOp or prescription in The Drug Prescription Register will give information on the outcome (yes/no). Binary data.
Complications	One year after surgery	Assessed according to the existing questions on complications in GynOp. Binary data.
Length of the perimenopausal state	Up to 55 years of age	Assessed in GynOp. Measured in days. Continous data.
Epithelial ovarian cancer including histopathological types and grade, primary tubal and peritoneal cancer, as well as clinical stage according to International Federation of Gynecology and Obstetrics (FIGO)	40 years	Assessed through The Swedish Cancer Register, The Swedish Quality Register for Gynaecological Cancer, The Swedish Cause of Death Register and The Swedish Population Register. Time-to event data.
Secondary expressions of estrogen deficiency	40 years	Measures of fractures related to osteoporosis and cardio-vascular events will be assessed through the Patient register. Binary and time-to-event data.
Change in menopausal symptom score	Up to 55 years of age	Assessed with Menopause Rating Scale (MRS) in GynOp. MRS is a validated scale consisting of 11 questions, each yields a score of 1-4. Total score is reported, ranging from 4 to 44, where 4 indicates no menopausal symptoms and 44 maximum symptoms. Ordered categorical data.
Subsequent surgery on uterus, salpinges and/or ovaries. Binary data.	At one year and up to 55 years of age	Assessed through GynOp and through The Patient register. Both registers yield the same data (subsequent surgery yes/no). Binary data.
Pregnancy	At one year and up to 55 years of age	Assessed in GynOp, whether pregnancy has occurred (yes/no). Binary data.
Perioperative blood loss	At day of surgery	In millilitres. Continous data.

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Göteborg, Sweden