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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by University of California, San Diego
Sponsor:
Information provided by (Responsible Party):
Garth Jacobsen, MD, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01398215
First received: July 14, 2011
Last updated: March 17, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention
Umbilical Hernia
Ventral Hernia
Procedure: transvaginal NOTES ventral hernia repair

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Transvaginal Ventral Hernia Repair

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • To assess outcomes related to the transvaginal NOTES approach to laparoscopic ventral hernia repair (through data collection). [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • To assess pain associated with the transvaginal NOTES approach to laparoscopic ventral hernia repair (through data collection). [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2009
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
transvaginal NOTES Procedure: transvaginal NOTES ventral hernia repair
ventral hernia repair via the transvaginal approach

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01398215

Contacts
Contact: Sarah Lazar, MPH 619-471-0447 misresearch@ucsd.edu

Locations
United States, California
University of California, San Diego Medical Center Recruiting
San Diego, California, United States, 92103
Contact: Sarah Lazar, MPH    619-471-0447    misresearch@ucsd.edu   
Principal Investigator: Garth Jacobsen, M.D.         
Sub-Investigator: Santiago Horgan, M.D.         
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Garth Jacobsen, M.D. UCSD
  More Information

Responsible Party: Garth Jacobsen, MD, Assistant Professor of Surgery, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01398215     History of Changes
Other Study ID Numbers: 081038, 150520 
Study First Received: July 14, 2011
Last Updated: March 17, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
umbilical hernia
ventral hernia

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Hernia, Umbilical
Pathological Conditions, Anatomical
Hernia, Abdominal
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on July 27, 2016