Cohort Study of Risk Reducing Salpingectomy

Prevention & Control Clinical Trial

— RRS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02165709
• Other study ID #: 14-0337
• Status: Completed
• Phase: N/A
• First received: June 13, 2014
• Last updated: April 21, 2017
• Start date: June 2014
• Est. completion date: September 2015

Study information

• Verified date: April 2017
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Ovary
• Prevention & Control
• Salpingectomy
• Sterilization, Tubal

Intervention

Procedure:
• Salpingectomy

• Traditional sterilization

Locations

Country	Name	City	State
United States	University of North Carolina Hosptials	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of women accepting RRS	Determination of patient demand/interest in pursuing RRS for sterilization during 12-month study period	12 months
Secondary	Percent of women with successful RRS completion	Feasibility will be defined as number (%) of successful RRS completion when intended	12 months