Clinical trial NCT03171467: Salpingectomy at the Time of Elective Laparoscopic Cholecystectomy (SaLCHE)
Official title: Salpingectomy in Women Undergoing Elective Laparoscopic Cholecystectomy (SaLCHE): A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prophylactic Salpingectomy
Opportunistic Salpingectomy
Laparoscopic Cholecystectomy
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: Krankenhaus der Barmherzigen Brüder Graz
name: Krankenhaus der Elisabethinen Graz
name: Landeskrankenhaus Feldbach
name: LKH Hartberg
name: Krankenhaus der Barmherzigen Brüder St. Veit/Glan
First posted: 2017-05-31
Enrollment: 100
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of opportunistic bilateral salpingectomy at the time of laparoscopic cholecystectomy
timeFrame: At time of laparoscopic cholecystectomy surgery
Secondary outcomes:
measure: Time
timeFrame: At the time of surgery
measure: Port repositioning
timeFrame: At surgery
measure: Complications
timeFrame: 30 days
measure: Patient-recorded outcome
timeFrame: Preop. and 1 year
Other outcomes:
Locations:
city: Feldbach
country: Austria
facility: Landeskrankenhaus Feldbach
city: Graz
country: Austria
facility: Krankenhaus der Barmherzigen Brüder Graz
city: Graz
country: Austria
facility: Krankenhaus der Elisabethinen Graz
city: Graz
country: Austria
facility: Medical University of Graz
city: Hartberg
country: Austria
facility: Landeskrankenhaus Hartberg
city: St. Veit/Glan
country: Austria
facility: Krankenhaus der Barmherzigen Brüder St. Veit/Glan
Study officials:
affiliation: Medical University of Graz
name: Karl F Tamussino, MD
role: STUDY_CHAIR
References:
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.
citation: Committee opinion no. 620: Salpingectomy for ovarian cancer prevention. Obstet Gynecol. 2015 Jan;125(1):279-281. doi: 10.1097/01.AOG.0000459871.88564.09.
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.
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.