Ventral Hernia Clinical Trial
— NOTESOfficial title:
Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Transvaginal Ventral Hernia Repair
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 |
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.
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) |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Diego Medical Center | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego |
United States,
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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