SALpingectomy for STERilization (SALSTER)

Study Overview
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Brief Summary
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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
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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.

Official Title
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SALpingectomy for STERilization (SALSTER); a Randomized Trial

Conditions
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Sterilization Tubal, Salpingectomy, Laparoscopy, Ovarian Reserve

Intervention / Treatment
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* Procedure: Laparoscopic tubal ligation
* Procedure: Laparoscopic bilateral salpingectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe complications | Complications according to the Clavien-Dindo classification or the specific questions on complications in GynOp. Binary data. | Eight weeks post-operatively | 
| Operative time | In minutes. Continous data. | At day of surgery | 
| Perioperative blood loss | In millilitres. Continous data. | At day of surgery | 
| Length of hospital stay | 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 | Assessed according to Clavien-Dindo. Binary data. | One year after surgery | 
| Complications | Assessed according to the existing questions on complications in GynOp. Binary data. | One year after surgery | 
| Age at the start of the perimenopausal state | Assessed through questionnaires in GynOp. Continous data. | Up to 55 years of age | 
| Length of the perimenopausal state | Assessed in GynOp. Measured in days. Continous data. | 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. | 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. | 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. | At one year and up to 55 years of age | 
| Pregnancy | Assessed in GynOp, whether pregnancy has occurred (yes/no). Binary data. | 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. | 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. | 40 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sterilization Tubal, Salpingectomy, Laparoscopy, Ovarian Reserve