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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01398215
Recruitment Status : Recruiting
First Posted : July 20, 2011
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Garth Jacobsen, MD, University of California, San Diego

Tracking Information
First Submitted Date July 14, 2011
First Posted Date July 20, 2011
Last Update Posted Date May 1, 2018
Study Start Date January 2009
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 11, 2015)
  • 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 ]
Original Primary Outcome Measures
 (submitted: July 19, 2011)
  • Safety and Efficacy as measured by pain and temperature log post-op [ Time Frame: 1 month ]
    Patient will be given a 7-day pain and temperature log on which they will record pain/temperature for 7 days post-op.
  • Safety and efficacy as measured by # of adverse events. [ Time Frame: 1 Year ]
Change History Complete list of historical versions of study NCT01398215 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Transvaginal Ventral Hernia Repair
Official Title Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Transvaginal Ventral Hernia Repair
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Umbilical Hernia
  • Ventral Hernia
Intervention Procedure: transvaginal NOTES ventral hernia repair
ventral hernia repair via the transvaginal approach
Study Groups/Cohorts transvaginal NOTES
Intervention: Procedure: transvaginal NOTES ventral hernia repair
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 11, 2015)
50
Original Estimated Enrollment
 (submitted: July 19, 2011)
10
Estimated Study Completion Date January 2019
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Sarah Lazar, MPH 619-471-0447 misresearch@ucsd.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01398215
Other Study ID Numbers 081038, 150520
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Garth Jacobsen, MD, University of California, San Diego
Study Sponsor University of California, San Diego
Collaborators Not Provided
Investigators
Principal Investigator: Garth Jacobsen, M.D. UCSD
PRS Account University of California, San Diego
Verification Date April 2018