Transvaginal NOTES Sleeve Gastrectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by University of California, San Diego
Sponsor:
Information provided by (Responsible Party):
Santiago Horgan, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01402505
First received: July 21, 2011
Last updated: March 26, 2015
Last verified: March 2015

July 21, 2011
March 26, 2015
October 2008
October 2018   (final data collection date for primary outcome measure)
To assess outcomes related to the transvaginal NOTES approach to laparoscopic sleeve gastrectomy (through data collection). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Pain and temperature assessment based on a log post-operatively. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Safety and efficacy assessment based on patient reported outcomes and the number of adverse events. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Sexual function assessment and the incidence of dyspareunia in TV NOTES sleeve patients. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Sexual function will be assessed with a standardized sexual function questionnaire at baseline and at 6 months post-op.
Complete list of historical versions of study NCT01402505 on ClinicalTrials.gov Archive Site
To assess pain associated with the transvaginal NOTES approach to laparoscopic sleeve gastrectomy (through data collection). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Transvaginal NOTES Sleeve Gastrectomy
Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Trans-Vaginal Sleeve Gastrectomy

This is a prospective chart review/data collection study of natural orifice translumenal endoscopic surgery (NOTES) for sleeve gastrectomy, that will include questionnaires administered throughout the study. Subjects enrolled will be those intending to have a transvaginal NOTES sleeve gastrectomy. Data will be collected and reviewed through 12 months post-op.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients between the ages of 18-75 who present in the UC San Diego Surgical Specialties clinic and have been cleared by the Bariatric and Metabolic Institute (BMI) team for bariatric surgery will be evaluated for participation in this trial. If the inclusion and exclusion criteria are met, the patients will be offered participation in the trial.

Obesity
Procedure: Transvaginal NOTES sleeve gastrectomy
transvaginal NOTES sleeve gastrectomy
Transvaginal NOTES sleeve gastrectomy
Transvaginal NOTES sleeve gastrectomy
Intervention: Procedure: Transvaginal NOTES sleeve gastrectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
October 2018
October 2018   (final data collection date for primary outcome measure)

Inclusion:

  1. Diagnosis of morbid obesity BMI > 40
  2. Female, age 18-75
  3. Mentally competent to give informed consent
  4. Scheduled to undergo a transvaginal NOTES sleeve gastrectomy

Exclusion:

  1. Pregnant women
  2. BMI < 40
Female
18 Years to 75 Years
No
Contact: Sarah Lazar, MPH 619-471-0447 misresearch@ucsd.edu
United States
 
NCT01402505
081036, 141812
No
Santiago Horgan, University of California, San Diego
University of California, San Diego
Not Provided
Principal Investigator: Santiago Horgan, M.D., FACS UCSD
University of California, San Diego
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP