NCT03171467

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

6 active sites

Status
completed

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 Start

First participant enrolled

August 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 31, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

1.7 years

First QC Date

April 28, 2017

Last Update Submit

April 16, 2018

Conditions

Prophylactic SalpingectomyOpportunistic SalpingectomyLaparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Time

    At the time of surgery

  • Port repositioning

    At surgery

  • Complications

    30 days

  • Patient-recorded outcome

    Preop. and 1 year

Study Arms (1)

Salpingectomy

EXPERIMENTAL

Opportunistic salpingectomy at the time of laparoscopic cholecystectomy

Procedure: Salpingectomy

Interventions

SalpingectomyPROCEDURE
Salpingectomy

Eligibility Criteria

Age45 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled (elective) laparoscopic cholecystectomy for a benign indication
  • Age \>45 years
  • Consent

You may not qualify if:

  • Age \<45 years
  • Desire to preserve fertility
  • Cholecystectomy for malignant disease
  • Extensive previous abdominal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Landeskrankenhaus Feldbach

Feldbach, 8330, Austria

Location

Krankenhaus der Barmherzigen Brüder Graz

Graz, 8020, Austria

Location

Krankenhaus der Elisabethinen Graz

Graz, 8020, Austria

Location

Medical University of Graz

Graz, 8036, Austria

Location

Landeskrankenhaus Hartberg

Hartberg, 8230, Austria

Location

Krankenhaus der Barmherzigen Brüder St. Veit/Glan

Saint Veit/Glan, 9300, Austria

Location

Related Publications (4)

  • 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.

    PMID: 28334425BACKGROUND

  • 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.

    PMID: 25560145BACKGROUND

  • 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

  • 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.

    PMID: 27012190BACKGROUND

MeSH Terms

Interventions

Salpingectomy

Intervention Hierarchy (Ancestors)

Gynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Karl F Tamussino, MD

    Medical University of Graz

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2017

First Posted

May 31, 2017

Study Start

August 1, 2016

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

April 17, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

AU(6)