An interventional study of Laparoscopic tubal ligation and Laparoscopic bilateral salpingectomy in Sterilization Tubal, Salpingectomy and Laparoscopy, sponsored by Göteborg University. Active, not recruiting at 1 site in Sweden. Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-17.
Sponsored by Göteborg University · Not applicable, Interventional, and Prevention
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.
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.
Göteborg University is the lead sponsor of 270 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients who seek for surgical permanent contraception and randomized to laparoscopic tubal ligation
Procedure: Laparoscopic tubal ligation
Patients who seek for surgical permanent contraception and randomized to laparoscopic bilateral salpingectomy
Procedure: Laparoscopic bilateral salpingectomy
Laparoscopic tubal ligation
Laparoscopic bilateral salpingectomy
Complications
Complication according to the Clavien-Dindo classification or specific questions on complications in GynOp Register (Swedish National Quality Register of Gynecological Surgery). Binary data.
Time frame: Eight weeks post-operatively
Age at menopause
Determined from questionnaires on bleeding pattern in GynOp. Continuous data.
Time frame: Twenty years
Severe complications
Complications according to the Clavien-Dindo classification or the specific questions on complications in GynOp. Binary data.
Time frame: Eight weeks post-operatively
Operative time
In minutes. Continous data.
Time frame: At day of surgery
Perioperative blood loss
In millilitres. Continous data.
Time frame: At day of surgery
Length of hospital stay
In Days. Continous data.
Time frame: Assessment will be done at discharge from hospital after surgery, including a period up to 8 weeks
Complications according to Clavien-Dindo
Assessed according to Clavien-Dindo. Binary data.
Time frame: One year after surgery
Complications
Assessed according to the existing questions on complications in GynOp. Binary data.
Time frame: One year after surgery
Age at the start of the perimenopausal state
Assessed through questionnaires in GynOp. Continous data.
Time frame: Up to 55 years of age
Length of the perimenopausal state
Assessed in GynOp. Measured in days. Continous data.
Time frame: Up to 55 years of age
Change in menopausal symptom score
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.
Time frame: Up to 55 years of age
Use of hormone replacement therapy at any time during follow-up
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.
Time frame: Up to 55 years of age
Subsequent surgery on uterus, salpinges and/or ovaries. Binary data.
Assessed through GynOp and through The Patient register. Both registers yield the same data (subsequent surgery yes/no). Binary data.
Time frame: At one year and up to 55 years of age
Pregnancy
Assessed in GynOp, whether pregnancy has occurred (yes/no). Binary data.
Time frame: At one year and 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)
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.
Time frame: 40 years
Secondary expressions of estrogen deficiency
Measures of fractures related to osteoporosis and cardio-vascular events will be assessed through the Patient register. Binary and time-to-event data.
Time frame: 40 years
Absolute change in AMH
Measured in mg/L. Continous data.
Time frame: Measured at baseline and 1 year post-operatively
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Started Apr 2019 (actual). Primary completion is estimated for Apr 2043, 288 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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