SALpingectomy for STERilization (SALSTER) (SALSTER)

July 10, 2023 updated by: Göteborg University

SALpingectomy for STERilization (SALSTER); a Randomized Trial

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

900

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Göteborg, Sweden, 413 45
        • Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Laparoscopic tubal ligation
Patients who seek for surgical permanent contraception and randomized to laparoscopic tubal ligation
Procedure: Laparoscopic tubal ligation
Laparoscopic tubal ligation
Active Comparator: Laparoscopic bilateral salpingectomy
Patients who seek for surgical permanent contraception and randomized to laparoscopic bilateral salpingectomy
Procedure: Laparoscopic bilateral salpingectomy
Laparoscopic bilateral salpingectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 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.
Eight weeks post-operatively
Age at menopause
Time Frame: Twenty years
Determined from questionnaires on bleeding pattern in GynOp. Continuous data.
Twenty years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severe complications
Time Frame: Eight weeks post-operatively
Complications according to the Clavien-Dindo classification or the specific questions on complications in GynOp. Binary data.
Eight weeks post-operatively
Operative time
Time Frame: At day of surgery
In minutes. Continous data.
At day of surgery
Perioperative blood loss
Time Frame: At day of surgery
In millilitres. Continous data.
At day of surgery
Length of hospital stay
Time Frame: Assessment will be done at discharge from hospital after surgery, including a period up to 8 weeks
In Days. Continous data.
Assessment will be done at discharge from hospital after surgery, including a period up to 8 weeks
Complications according to Clavien-Dindo
Time Frame: One year after surgery
Assessed according to Clavien-Dindo. Binary data.
One year after surgery
Complications
Time Frame: One year after surgery
Assessed according to the existing questions on complications in GynOp. Binary data.
One year after surgery
Age at the start of the perimenopausal state
Time Frame: Up to 55 years of age
Assessed through questionnaires in GynOp. Continous data.
Up to 55 years of age
Length of the perimenopausal state
Time Frame: Up to 55 years of age
Assessed in GynOp. Measured in days. Continous data.
Up to 55 years of age
Change in menopausal symptom score
Time Frame: 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.
Up to 55 years of age
Use of hormone replacement therapy at any time during follow-up
Time Frame: 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.
Up to 55 years of age
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)
Time Frame: 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.
40 years
Secondary expressions of estrogen deficiency
Time Frame: 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.
40 years
Subsequent surgery on uterus, salpinges and/or ovaries. Binary data.
Time Frame: 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.
At one year and up to 55 years of age
Pregnancy
Time Frame: At one year and up to 55 years of age
Assessed in GynOp, whether pregnancy has occurred (yes/no). Binary data.
At one year and up to 55 years of age

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute change in AMH
Time Frame: Measured at baseline and 1 year post-operatively
Measured in mg/L. Continous data.
Measured at baseline and 1 year post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Collaborators

Umeå University

Investigators

  • Principal Investigator: Annika Strandell, Sahlgrenska Academy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2019

Primary Completion (Estimated)

April 1, 2043

Study Completion (Estimated)

December 31, 2050

Study Registration Dates

First Submitted

October 30, 2018

First Submitted That Met QC Criteria

March 1, 2019

First Posted (Actual)

March 4, 2019

Study Record Updates

Last Update Posted (Actual)

July 11, 2023

Last Update Submitted That Met QC Criteria

July 10, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 316-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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