RRS: Cohort Study of Risk Reducing Salpingectomy

Sponsor

University of North Carolina, Chapel Hill (Other)

Overall Status

Completed

CT.gov ID

NCT02165709

Collaborator

Medtronic - MITG (Industry)

Enrollment

Location

Arms

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Sterilization, Tubal Salpingectomy Ovary Prevention & Control	Procedure: Salpingectomy Procedure: Traditional sterilization	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Percent of women accepting RRS [12 months]
Determination of patient demand/interest in pursuing RRS for sterilization during 12-month study period

Secondary Outcome Measures

Percent of women with successful RRS completion [12 months]
Feasibility will be defined as number (%) of successful RRS completion when intended

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of North Carolina Hosptials	Chapel Hill	North Carolina	United States	27599

Sponsors and Collaborators

University of North Carolina, Chapel Hill
Medtronic - MITG

Investigators

Principal Investigator: Matthew L Zerden, MD, MPH, University of North Carolina, Chapel Hill

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of North Carolina, Chapel Hill

ClinicalTrials.gov Identifier:

NCT02165709

Other Study ID Numbers:

14-0337

First Posted:

Jun 17, 2014

Last Update Posted:

Apr 25, 2017

Last Verified:

Apr 1, 2017

Study Results

No Results Posted as of Apr 25, 2017