Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Transvaginal Ventral Hernia Repair
NOTES
1 other identifier
observational
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 14, 2011
CompletedFirst Posted
Study publicly available on registry
July 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedMay 1, 2018
April 1, 2018
10 years
July 14, 2011
April 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To assess outcomes related to the transvaginal NOTES approach to laparoscopic ventral hernia repair (through data collection).
1 Year
To assess pain associated with the transvaginal NOTES approach to laparoscopic ventral hernia repair (through data collection).
1 Year
Study Arms (1)
transvaginal NOTES
Interventions
ventral hernia repair via the transvaginal approach
Eligibility Criteria
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
You may qualify if:
- Umbilical or incisional hernia greater than 2 cm in size
- Female, age 18-75
- Mentally competent to give informed consent
- Scheduled to undergo a transvaginal NOTES ventral hernia repair
You may not qualify if:
- Pregnant women
- Patients with defects measuring greater than 10 cm in size
- Patients with complex hernias requiring fascial mobilization for closure
- Morbidly obese patients (BMI \>45)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, San Diego Medical Center
San Diego, California, 92103, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Garth Jacobsen, M.D.
UCSD
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Surgery
Study Record Dates
First Submitted
July 14, 2011
First Posted
July 20, 2011
Study Start
January 1, 2009
Primary Completion
January 1, 2019
Study Completion
January 1, 2019
Last Updated
May 1, 2018
Record last verified: 2018-04