Recruiting

NOTES

Sponsor:

UCLA

Code:

NCT01398215

Conditions

Umbilical Hernia

Ventral Hernia

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

transvaginal NOTES ventral hernia repair

Study Details

Brief 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.

Conditions

Umbilical Hernia

Ventral Hernia

Study ID

NCT01398215

Start date

Jan, 2009

Status verified date

Apr, 2018

Completion date

Jan, 2019

Anticipated

Primary completion date

Jan, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

transvaginal NOTES

Interventions

transvaginal NOTES ventral hernia repair

ventral hernia repair via the transvaginal approach

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Sarah Lazar, MPH

619-471-0447misresearch@ucsd.edu

Locations

University of California, San Diego Medical Center

Recruiting

San Diego, California, United States, 92103

Contacts

Sarah Lazar, MPH

619-471-0447misresearch@ucsd.edu

Principal Investigator:

Garth Jacobsen, M.D.

More Information

Sponsor

University of California, San Diego

Last update posted

May 1, 2018

Last verified

Apr, 2018

Keywords

  • umbilical hernia
  • ventral hernia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2018-05-01.