Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Transvaginal Ventral Hernia Repair (NOTES)

April 30, 2018 updated by: Garth Jacobsen, MD, University of California, San Diego
This is a prospective chart review/data collection study of natural orifice translumenal endoscopic surgery (NOTES) for ventral hernia repair, that will include questionnaires administered throughout the study. Subjects enrolled will be those intending to have a transvaginal NOTES ventral hernia repair. Data will be collected and reviewed through 12 months post-op.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92103
        • Recruiting
        • University of California, San Diego Medical Center
        • Principal Investigator:
          • Garth Jacobsen, M.D.
        • Sub-Investigator:
          • Santiago Horgan, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All patients who come to the UC San Diego Surgical Specialties clinic and have chosen to undergo a ventral hernia repair will be evaluated for participation in this tria

Description

Inclusion:

  1. Umbilical or incisional hernia greater than 2 cm in size
  2. Female, age 18-75
  3. Mentally competent to give informed consent
  4. Scheduled to undergo a transvaginal NOTES ventral hernia repair

Exclusion:

  1. Pregnant women
  2. Patients with defects measuring greater than 10 cm in size
  3. Patients with complex hernias requiring fascial mobilization for closure
  4. Morbidly obese patients (BMI >45)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
transvaginal NOTES
Procedure: transvaginal NOTES ventral hernia repair
ventral hernia repair via the transvaginal approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess outcomes related to the transvaginal NOTES approach to laparoscopic ventral hernia repair (through data collection).
Time Frame: 1 Year
1 Year
To assess pain associated with the transvaginal NOTES approach to laparoscopic ventral hernia repair (through data collection).
Time Frame: 1 Year
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Investigators

  • Principal Investigator: Garth Jacobsen, M.D., UCSD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

July 14, 2011

First Submitted That Met QC Criteria

July 19, 2011

First Posted (Estimate)

July 20, 2011

Study Record Updates

Last Update Posted (Actual)

May 1, 2018

Last Update Submitted That Met QC Criteria

April 30, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 081038, 150520

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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