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NCT01398215 Clinical Trial

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

Ventral Hernia Clinical Trial

— NOTES  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01398215
Other study ID # 081038, 150520
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2009
Est. completion date January 2019

Study information
Verified date April 2018
Source University of California, San Diego
Contact Sarah Lazar, MPH
Phone 619-471-0447
Email misresearch@ucsd.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date January 2019
Est. primary completion date January 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• transvaginal NOTES ventral hernia repair
ventral hernia repair via the transvaginal approach

Locations
Country Name City State
United States University of California, San Diego Medical Center San Diego California

Sponsors (1)
Lead Sponsor Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To assess outcomes related to the transvaginal NOTES approach to laparoscopic ventral hernia repair (through data collection). 1 Year
Primary To assess pain associated with the transvaginal NOTES approach to laparoscopic ventral hernia repair (through data collection). 1 Year
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