Trial record 5 of 26 for:    salpingectomy

Cohort Study of Risk Reducing Salpingectomy (RRS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by University of North Carolina, Chapel Hill
Sponsor:
Collaborator:
Covidien
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT02165709
First received: June 13, 2014
Last updated: April 6, 2015
Last verified: April 2015
  Purpose

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 Intervention
Sterilization, Tubal
Salpingectomy
Ovary
Prevention & Control
Procedure: Salpingectomy
Procedure: Traditional sterilization

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cohort Study of Risk Reducing Salpingectomy (RRS) Versus Standard Tubal Sterilization Among Women Who Desire Sterilization

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Percent of women accepting RRS [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Feasibility will be defined as number (%) of successful RRS completion when intended


Estimated Enrollment: 50
Study Start Date: June 2014
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02165709

Contacts
Contact: Matthew L Zerden, MD 9198435633 zerden@med.unc.edu

Locations
United States, North Carolina
University of North Carolina Hosptials Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Matthew Zerden, MD, MPH    919-843-5633    zerden@med.unc.edu   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Covidien
Investigators
Principal Investigator: Matthew L Zerden, MD, MPH University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02165709     History of Changes
Other Study ID Numbers: 14-0337
Study First Received: June 13, 2014
Last Updated: April 6, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Disinfectants
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2015