Cohort Study of Risk Reducing Salpingectomy (RRS)

Cohort Study of Risk Reducing Salpingectomy (RRS) Versus Standard Tubal Sterilization Among Women Who Desire Sterilization

Women undergoing surgical sterilization will be interested in risk reducing salpingectomy, and surgeons performing the procedure will be able to successfully complete the salpingectomy.

Study Overview

• Status: Completed
• Conditions: Prevention & Control; Sterilization, Tubal; Salpingectomy; Ovary
• Intervention / Treatment: Procedure: Salpingectomy; Procedure: Traditional sterilization

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina Hosptials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women > 35 years requesting sterilization as interval procedure OR at time of cesarean delivery
• At least one living child
• English or Spanish speaking
• Sterilization planned as interval (laparoscopic) procedure via Family Planning Clinic services or at time of delivery
• Delivery by cesarean section (planned or following labor)

Exclusion Criteria:

• Age < 30
• Medical complications that increase risk for surgical bleeding (e.g. Idiopathic thrombocytopenic purpura (ITP); von Willebrand disease (vWD); need for prophylactic or therapeutic anticoagulation)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Salpingectomy; Participants will be offered a risk-reducing salpingectomy, and if they choose this options the surgeon will proceed with a salpingectomy.	Procedure: Salpingectomy
Active Comparator: Traditional sterilization; Participants will be offered a risk-reducing salpingectomy, and those that choose a traditional sterilization will be in this treatment arm.	Procedure: Traditional sterilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of women accepting RRS	Determination of patient demand/interest in pursuing RRS for sterilization during 12-month study period	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of women with successful RRS completion	Feasibility will be defined as number (%) of successful RRS completion when intended	12 months

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Medtronic - MITG
• Investigators: Principal Investigator: Matthew L Zerden, MD, MPH, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: June 13, 2014
• First Submitted That Met QC Criteria: June 13, 2014
• First Posted (Estimate): June 17, 2014

Study Record Updates

• Last Update Posted (Actual): April 25, 2017
• Last Update Submitted That Met QC Criteria: April 21, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 14-0337