Salpingectomy at the Time of Elective Laparoscopic Cholecystectomy (SaLCHE)

NCT ID: NCT03171467

Last Updated: 2018-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-01

Study Completion Date

2018-04-01

Brief Summary

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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

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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.

Conditions

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Prophylactic Salpingectomy Opportunistic Salpingectomy Laparoscopic Cholecystectomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Salpingectomy

Opportunistic salpingectomy at the time of laparoscopic cholecystectomy

Group Type EXPERIMENTAL

Salpingectomy

Intervention Type PROCEDURE

Interventions

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Salpingectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Krankenhaus der Barmherzigen Brüder Graz

UNKNOWN

Sponsor Role collaborator

Krankenhaus der Elisabethinen Graz

UNKNOWN

Sponsor Role collaborator

Landeskrankenhaus Feldbach

OTHER

Sponsor Role collaborator

LKH Hartberg

UNKNOWN

Sponsor Role collaborator

Krankenhaus der Barmherzigen Brüder St. Veit/Glan

UNKNOWN

Sponsor Role collaborator

Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karl F Tamussino, MD

Role: STUDY_CHAIR

Medical University of Graz

Locations

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Landeskrankenhaus Feldbach

Feldbach, , Austria

Site Status

Krankenhaus der Barmherzigen Brüder Graz

Graz, , Austria

Site Status

Krankenhaus der Elisabethinen Graz

Graz, , Austria

Site Status

Medical University of Graz

Graz, , Austria

Site Status

Landeskrankenhaus Hartberg

Hartberg, , Austria

Site Status

Krankenhaus der Barmherzigen Brüder St. Veit/Glan

Saint Veit/Glan, , Austria

Site Status

Countries

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Austria

References

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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.

Reference Type BACKGROUND
PMID: 28334425 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25560145 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25628372 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27012190 (View on PubMed)

Other Identifiers

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SaLCHE

Identifier Type: -

Identifier Source: org_study_id

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