NCT03860805

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
301mo left

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Apr 2019Dec 2050

First Submitted

Initial submission to the registry

October 30, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 4, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

April 3, 2019

Completed
24 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2043

Expected
7.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2050

Last Updated

January 17, 2025

Status Verified

January 1, 2025

Enrollment Period

24 years

First QC Date

October 30, 2018

Last Update Submit

January 15, 2025

Conditions

Sterilization TubalSalpingectomyLaparoscopyOvarian Reserve

Keywords

Sterilization TubalSalpingectomyLaparoscopyOvarian Reserve

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (14)

  • Severe complications

    Eight weeks post-operatively

  • Operative time

    At day of surgery

  • Perioperative blood loss

    At day of surgery

  • Length of hospital stay

    Assessment will be done at discharge from hospital after surgery, including a period up to 8 weeks

  • Complications according to Clavien-Dindo

    One year after surgery

  • +9 more secondary outcomes

Other Outcomes (1)

  • Absolute change in AMH

    Measured at baseline and 1 year post-operatively

Study Arms (2)

Laparoscopic tubal ligation

ACTIVE COMPARATOR

Patients who seek for surgical permanent contraception and randomized to laparoscopic tubal ligation

Procedure: Laparoscopic tubal ligation

Laparoscopic bilateral salpingectomy

ACTIVE COMPARATOR

Patients who seek for surgical permanent contraception and randomized to laparoscopic bilateral salpingectomy

Procedure: Laparoscopic bilateral salpingectomy

Interventions

Laparoscopic tubal ligationPROCEDURE

Laparoscopic tubal ligation

Laparoscopic tubal ligation
Laparoscopic bilateral salpingectomyPROCEDURE

Laparoscopic bilateral salpingectomy

Laparoscopic bilateral salpingectomy

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Planned laparoscopic sterilization
  • Willing to be randomized

You may not qualify if:

  • Women older than 49
  • Not understanding the oral or written study information
  • Previous malignancy involving radiation, chemotherapy or endocrine treatment affecting ovarian function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location

Related Publications (17)

  • 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

    BACKGROUND

  • Dilley SE, Havrilesky LJ, Bakkum-Gamez J, Cohn DE, Michael Straughn J Jr, Caughey AB, Rodriguez MI. Cost-effectiveness of opportunistic salpingectomy for ovarian cancer prevention. Gynecol Oncol. 2017 Aug;146(2):373-379. doi: 10.1016/j.ygyno.2017.05.034. Epub 2017 Jun 1.

    PMID: 28577884BACKGROUND

  • Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

    PMID: 15273542BACKGROUND

  • Falconer H, Yin L, Gronberg H, Altman D. Ovarian cancer risk after salpingectomy: a nationwide population-based study. J Natl Cancer Inst. 2015 Jan 27;107(2):dju410. doi: 10.1093/jnci/dju410. Print 2015 Feb.

    PMID: 25628372BACKGROUND

  • Ganer Herman H, Gluck O, Keidar R, Kerner R, Kovo M, Levran D, Bar J, Sagiv R. Ovarian reserve following cesarean section with salpingectomy vs tubal ligation: a randomized trial. Am J Obstet Gynecol. 2017 Oct;217(4):472.e1-472.e6. doi: 10.1016/j.ajog.2017.04.028. Epub 2017 Apr 25.

    PMID: 28455082BACKGROUND

  • Heinemann K, Ruebig A, Potthoff P, Schneider HP, Strelow F, Heinemann LA, Do MT. The Menopause Rating Scale (MRS) scale: a methodological review. Health Qual Life Outcomes. 2004 Sep 2;2:45. doi: 10.1186/1477-7525-2-45.

    PMID: 15345062BACKGROUND

  • Helden JV, Weiskirchen R. Age-independent anti-Mullerian hormone (AMH) standard deviation scores to estimate ovarian function. Eur J Obstet Gynecol Reprod Biol. 2017 Jun;213:64-70. doi: 10.1016/j.ejogrb.2017.04.029. Epub 2017 Apr 18.

    PMID: 28437631BACKGROUND

  • Kotlyar A, Gingold J, Shue S, Falcone T. The Effect of Salpingectomy on Ovarian Function. J Minim Invasive Gynecol. 2017 May-Jun;24(4):563-578. doi: 10.1016/j.jmig.2017.02.014. Epub 2017 Feb 20.

    PMID: 28223181BACKGROUND

  • Labidi-Galy SI, Papp E, Hallberg D, Niknafs N, Adleff V, Noe M, Bhattacharya R, Novak M, Jones S, Phallen J, Hruban CA, Hirsch MS, Lin DI, Schwartz L, Maire CL, Tille JC, Bowden M, Ayhan A, Wood LD, Scharpf RB, Kurman R, Wang TL, Shih IM, Karchin R, Drapkin R, Velculescu VE. High grade serous ovarian carcinomas originate in the fallopian tube. Nat Commun. 2017 Oct 23;8(1):1093. doi: 10.1038/s41467-017-00962-1.

    PMID: 29061967BACKGROUND

  • McKinlay SM, Brambilla DJ, Posner JG. The normal menopause transition. Maturitas. 1992 Jan;14(2):103-15. doi: 10.1016/0378-5122(92)90003-m.

    PMID: 1565019BACKGROUND

  • Shih IeM, Kurman RJ. Ovarian tumorigenesis: a proposed model based on morphological and molecular genetic analysis. Am J Pathol. 2004 May;164(5):1511-8. doi: 10.1016/s0002-9440(10)63708-x.

    PMID: 15111296BACKGROUND

  • Shinar S, Blecher Y, Alpern S, Many A, Ashwal E, Amikam U, Cohen A. Total bilateral salpingectomy versus partial bilateral salpingectomy for permanent sterilization during cesarean delivery. Arch Gynecol Obstet. 2017 May;295(5):1185-1189. doi: 10.1007/s00404-017-4340-x. Epub 2017 Mar 11.

    PMID: 28285425BACKGROUND

  • Tehrani FR, Mansournia MA, Solaymani-Dodaran M, Azizi F. Age-specific serum anti-Mullerian hormone levels: estimates from a large population-based sample. Climacteric. 2014 Oct;17(5):591-7. doi: 10.3109/13697137.2014.912262. Epub 2014 Jul 9.

    PMID: 24716733BACKGROUND

  • Trabuco EC, Moorman PG, Algeciras-Schimnich A, Weaver AL, Cliby WA. Association of Ovary-Sparing Hysterectomy With Ovarian Reserve. Obstet Gynecol. 2016 May;127(5):819-827. doi: 10.1097/AOG.0000000000001398.

    PMID: 27054925BACKGROUND

  • Wang Y, Mang M, Wang Y, Wang L, Klein R, Kong B, Zheng W. Tubal origin of ovarian endometriosis and clear cell and endometrioid carcinoma. Am J Cancer Res. 2015 Feb 15;5(3):869-79. eCollection 2015.

    PMID: 26045974BACKGROUND

  • Strandell A, Magarakis L, Sundfeldt K, Palsson M, Liv P, Idahl A. Salpingectomy versus tubal occlusion in laparoscopic sterilisation (SALSTER): a national register-based randomised non-inferiority trial. Lancet Reg Health Eur. 2024 Aug 11;45:101026. doi: 10.1016/j.lanepe.2024.101026. eCollection 2024 Oct.

    PMID: 39974774DERIVED

  • Magarakis L, Idahl A, Sundfeldt K, Liv P, Palsson M, Strandell A. SALpingectomy for STERilisation (SALSTER): study protocol for a Swedish multicentre register-based randomised controlled trial. BMJ Open. 2023 Sep 4;13(9):e071246. doi: 10.1136/bmjopen-2022-071246.

    PMID: 37666548DERIVED

Study Officials

  • Annika Strandell

    Sahlgrenska Academy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2018

First Posted

March 4, 2019

Study Start

April 3, 2019

Primary Completion (Estimated)

April 1, 2043

Study Completion (Estimated)

December 31, 2050

Last Updated

January 17, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)