SALpingectomy for STERilization (SALSTER)

Laparoscopy Clinical Trial

— SALSTER  

Official title:

SALpingectomy for STERilization (SALSTER); a Randomized Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03860805
• Other study ID #: 316-18
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 3, 2019
• Est. completion date: December 31, 2050

Study information

• Verified date: July 2023
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 900
• Est. completion date: December 31, 2050
• Est. primary completion date: April 2043
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Laparoscopy
• Ovarian Reserve
• Salpingectomy
• Sterilization Tubal

Intervention

Procedure:
• Laparoscopic tubal ligation
Laparoscopic tubal ligation
• Laparoscopic bilateral salpingectomy
Laparoscopic bilateral salpingectomy

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Göteborg

Sponsors (2)

Lead Sponsor	Collaborator
Göteborg University	Umeå University

Country where clinical trial is conducted

Sweden, 

References & Publications (15)

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Absolute change in AMH	Measured in mg/L. Continous data.	Measured at baseline and 1 year post-operatively
Primary	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
Primary	Age at menopause	Determined from questionnaires on bleeding pattern in GynOp. Continuous data.	Twenty years
Secondary	Severe complications	Complications according to the Clavien-Dindo classification or the specific questions on complications in GynOp. Binary data.	Eight weeks post-operatively
Secondary	Operative time	In minutes. Continous data.	At day of surgery
Secondary	Perioperative blood loss	In millilitres. Continous data.	At day of surgery
Secondary	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
Secondary	Complications according to Clavien-Dindo	Assessed according to Clavien-Dindo. Binary data.	One year after surgery
Secondary	Complications	Assessed according to the existing questions on complications in GynOp. Binary data.	One year after surgery
Secondary	Age at the start of the perimenopausal state	Assessed through questionnaires in GynOp. Continous data.	Up to 55 years of age
Secondary	Length of the perimenopausal state	Assessed in GynOp. Measured in days. Continous data.	Up to 55 years of age
Secondary	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
Secondary	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
Secondary	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
Secondary	Pregnancy	Assessed in GynOp, whether pregnancy has occurred (yes/no). Binary data.	At one year and up to 55 years of age
Secondary	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	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