Clinical trial NCT03860805: SALpingectomy for STERilization (SALSTER)
Official title: SALpingectomy for STERilization (SALSTER); a Randomized Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sterilization Tubal
Salpingectomy
Laparoscopy
Ovarian Reserve
Keywords: Sterilization Tubal
Salpingectomy
Laparoscopy
Ovarian Reserve
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Umeå University
First posted: 2019-03-04
Enrollment: 900
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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 outcomes:
measure: Complications
timeFrame: Eight weeks post-operatively
measure: Age at menopause
timeFrame: Twenty years
Secondary outcomes:
measure: Severe complications
timeFrame: Eight weeks post-operatively
measure: Operative time
timeFrame: At day of surgery
measure: Perioperative blood loss
timeFrame: At day of surgery
measure: Length of hospital stay
timeFrame: Assessment will be done at discharge from hospital after surgery, including a period up to 8 weeks
measure: Complications according to Clavien-Dindo
timeFrame: One year after surgery
measure: Complications
timeFrame: One year after surgery
measure: Age at the start of the perimenopausal state
timeFrame: Up to 55 years of age
measure: Length of the perimenopausal state
timeFrame: Up to 55 years of age
measure: Change in menopausal symptom score
timeFrame: Up to 55 years of age
measure: Use of hormone replacement therapy at any time during follow-up
timeFrame: Up to 55 years of age
measure: Subsequent surgery on uterus, salpinges and/or ovaries. Binary data.
timeFrame: At one year and up to 55 years of age
measure: Pregnancy
timeFrame: At one year and up to 55 years of age
measure: 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)
timeFrame: 40 years
measure: Secondary expressions of estrogen deficiency
timeFrame: 40 years
Other outcomes:
measure: Absolute change in AMH
timeFrame: Measured at baseline and 1 year post-operatively
Locations:
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska Academy
name: Annika Strandell
role: PRINCIPAL_INVESTIGATOR
References:
citation: Collins, E., Strandell, A., Granåsen, G., I. A. (2018). Increased risk of menopausal symptoms one year after opportunistic salpingectomy - A retrospective observational cohort study based on the Swedish National Quality Register of Gynecological Surgery. Paris: EBCOG. Retrieved from http://www.ebcog2018.org/content/detailed-program
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