Opportunistic Salpingectomy in Non-gynecological Surgeries

Opportunistic Salpingectomy in Non-gynecological Surgeries - a Pilot Study

The goal of this study is to evaluate patient's compliance for opportunistic salpingectomy (OS) and procedure feasibility in non gynecological abdominal surgeries

Study Overview

• Status: Completed
• Conditions: Ovarian Cancer Prevention
• Intervention / Treatment: Procedure: salpingectomy

Detailed Description

Patients who are candidate for non-gynecological abdominal surgery, are offered OS. If agree, a general surgeon perform the procedure during the planned abdominal surgery

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Kfar Saba, Israel
    • Meir Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women who were candidates for non-gynecological abdominal surgery
• Aged 45 or older, or aged 40 or older with a desire for bilateral salpingectomy

Exclusion Criteria:

• Pregnant women
• Candidates for urgent surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: non-gynecologic surgery; Female candidates for non-gynecologic abdominal surgery	Procedure: salpingectomy; surgical removal of the fallopian tubes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patients willing for salpingectomy	The number of patients that will agree for salpingectomy	day of enrollment
patients undergoing salpingectomy	The number of patients that will undergo salpingectomy	from enrollment and up to 6 weeks
length of salpingectomy	the length (in minutes) of salpingectomy	within surgery
surgical complications	complications during or after salpingectomy	up to 30 days from surgery

Collaborators and Investigators

• Sponsor: Dana Josephy

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: July 19, 2023
• First Submitted That Met QC Criteria: September 4, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 4, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MeirMedicalCenter

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No