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SALpingectomy for STERilization (SALSTER) (SALSTER)

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ClinicalTrials.gov Identifier: NCT03860805
Recruitment Status : Not yet recruiting
First Posted : March 4, 2019
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sterilization Tubal Salpingectomy Laparoscopy Ovarian Reserve Procedure: Laparoscopic tubal ligation Procedure: Laparoscopic bilateral salpingectomy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: SALpingectomy for STERilization (SALSTER); a Randomized Trial
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2050

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




Primary Outcome Measures :
  1. 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.

  2. Age at menopause [ Time Frame: One year ]
    Determined from questionnaires on bleeding pattern in GynOp. Continuous data.


Secondary Outcome Measures :
  1. 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.

  2. Operative time [ Time Frame: At day of surgery ]
    In minutes. Continous data.

  3. Perioperative blood loss [ Time Frame: At day of surgery ]
    In millilitres. Continous data.

  4. 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.

  5. Complications according to Clavien-Dindo [ Time Frame: One year after surgery ]
    Assessed according to Clavien-Dindo. Binary data.

  6. Complications [ Time Frame: One year after surgery ]
    Assessed according to the existing questions on complications in GynOp. Binary data.

  7. Age at the start of the perimenopausal state [ Time Frame: Up to 55 years of age ]
    Assessed through questionnaires in GynOp. Continous data.

  8. Length of the perimenopausal state [ Time Frame: Up to 55 years of age ]
    Assessed in GynOp. Measured in days. Continous data.

  9. 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.

  10. 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.

  11. Subsequent surgery on uterus, salpinges and/or ovaries. Binary data. [ Time Frame: 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.

  12. Pregnancy [ Time Frame: Up to 55 years of age ]
    Assessed in GynOp, whether pregnancy has occurred (yes/no). Binary data.

  13. 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.

  14. 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.


Other Outcome Measures:
  1. Absolute change in AMH [ Time Frame: Measured at baseline and 1 year post-operatively ]
    Measured in mg/L. Continous data.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03860805


Contacts
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Contact: Annika Strandell +47(0)700904454 annika.strandell@vgregion.se
Contact: Annika Idahl +47(0)703231513 annika.idahl@umu.se

Locations
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Sweden
Sahlgrenska University Hospital
Göteborg, Sweden, 413 45
Sponsors and Collaborators
Göteborg University
Investigators
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Principal Investigator: Annika Strandell Sahlgrenska Academy

Publications:
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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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT03860805     History of Changes
Other Study ID Numbers: 316-18
First Posted: March 4, 2019    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Göteborg University:
Sterilization Tubal
Salpingectomy
Laparoscopy
Ovarian Reserve