Salpingectomy at the Time of Elective Laparoscopic Cholecystectomy (SaLCHE)

Laparoscopic Cholecystectomy Clinical Trial

— SaLCHE  

Official title:

Salpingectomy in Women Undergoing Elective Laparoscopic Cholecystectomy (SaLCHE): A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03171467
• Other study ID #: SaLCHE
• Status: Completed
• Phase: N/A
• First received: April 28, 2017
• Last updated: April 16, 2018
• Start date: August 1, 2016
• Est. completion date: April 1, 2018

Study information

• Verified date: April 2018
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prophylactic salpingectomy (also called opportunistic, risk-reducing or incidental salpingectomy) has been advocated at the time of gynecologic surgery to reduce the risk of serous ovarian cancer. This study explores the acceptability and feasibility of opportunistic salpingectomy at the time of elective laparoscopic cholecystectomy (LCHE).

Description:

Many serous ovarian cancers are now thought to originate in the fimbria of the fallopian tubes. This has led a number of professional societies worldwide to recommend consideration of prophylactic salpingectomy at the time of elective gynecologic surgery or tubal sterilization.

This study explores the acceptability and feasibility of incidental (opportunistic, risk-reducing, prophylactic) salpingectomy at the time of a common nongynecologic procedure in women, i.e. elective laparoscopic cholecystectomy (LCHE). The study addresses whether women ≥45 years would accept opportunistic salpingectomy and the technical feasibility (time, port placement, complications) in women who consented to salpingectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 1, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• Scheduled (elective) laparoscopic cholecystectomy for a benign indication

• Age >45 years

• Consent

Exclusion Criteria:

• Age <45 years

• Desire to preserve fertility

• Cholecystectomy for malignant disease

• Extensive previous abdominal surgery

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy
• Opportunistic Salpingectomy
• Prophylactic Salpingectomy

Intervention

Procedure:
• Salpingectomy

Locations

Country	Name	City	State
Austria	Landeskrankenhaus Feldbach	Feldbach
Austria	Krankenhaus der Barmherzigen Brüder Graz	Graz
Austria	Krankenhaus der Elisabethinen Graz	Graz
Austria	Medical University of Graz	Graz
Austria	Landeskrankenhaus Hartberg	Hartberg
Austria	Krankenhaus der Barmherzigen Brüder St. Veit/Glan	St. Veit/Glan

Sponsors (6)

Lead Sponsor	Collaborator
Medical University of Graz	Krankenhaus der Barmherzigen Brüder Graz, Krankenhaus der Barmherzigen Brüder St. Veit/Glan, Krankenhaus der Elisabethinen Graz, Landeskrankenhaus Feldbach, LKH Hartberg

Country where clinical trial is conducted

Austria, 

References & Publications (4)

Committee on Gynecologic Practice. Committee opinion no. 620: Salpingectomy for ovarian cancer prevention. Obstet Gynecol. 2015 Jan;125(1):279-81. doi: 10.1097/01.AOG.0000459871.88564.09. Erratum in: Obstet Gynecol. 2016 Feb;127(2):405. Obstet Gynecol. 2016 Feb;127(2):405. — View Citation

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

Kurman RJ, Shih IeM. The Dualistic Model of Ovarian Carcinogenesis: Revisited, Revised, and Expanded. Am J Pathol. 2016 Apr;186(4):733-47. doi: 10.1016/j.ajpath.2015.11.011. Review. — View Citation

Long Roche KC, Abu-Rustum NR, Nourmoussavi M, Zivanovic O. Risk-reducing salpingectomy: Let us be opportunistic. Cancer. 2017 May 15;123(10):1714-1720. doi: 10.1002/cncr.30528. Epub 2017 Mar 23. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of opportunistic bilateral salpingectomy at the time of laparoscopic cholecystectomy	Evaluation of how often opportunistic bilateral salpingectomy can be accomplished at the time of laparoscopic cholecystectomy	At time of laparoscopic cholecystectomy surgery
Secondary	Time	Time (in minutes) from completion of cholecystectomy to completion of bilateral salpingectomy	At the time of surgery
Secondary	Port repositioning	Rate of port repositioning	At surgery
Secondary	Complications	Number of complications due to salpingectomy	30 days
Secondary	Patient-recorded outcome	Bliem Questionnaire	Preop. and 1 year