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Transvaginal NOTES Sleeve Gastrectomy

This study is currently recruiting participants.
Verified October 2016 by Santiago Horgan, University of California, San Diego
Sponsor:
ClinicalTrials.gov Identifier:
NCT01402505
First Posted: July 26, 2011
Last Update Posted: October 26, 2016
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.
Information provided by (Responsible Party):
Santiago Horgan, University of California, San Diego
July 21, 2011
July 26, 2011
October 26, 2016
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 ]
  • Safety and efficacy assessment based on patient reported outcomes and the number of adverse events. [ Time Frame: 1 year ]
  • Pain and temperature assessment based on a log post-operatively. [ Time Frame: 1 year ]
  • Sexual function assessment and the incidence of dyspareunia in TV NOTES sleeve patients. [ Time Frame: 1 year ]
    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 ]
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
Sexes Eligible for Study: Female
18 Years to 75 Years   (Adult, Senior)
No
Contact: Sarah Lazar, MPH 619-471-0447 misresearch@ucsd.edu
United States
 
 
NCT01402505
081036, 141812
No
Not Provided
Not Provided
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
October 2016