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Transvaginal NOTES Sleeve Gastrectomy

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ClinicalTrials.gov Identifier: NCT01402505
Recruitment Status : Recruiting
First Posted : July 26, 2011
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Santiago Horgan, University of California, San Diego

Brief Summary:
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.

Condition or disease Intervention/treatment
Obesity Procedure: Transvaginal NOTES sleeve gastrectomy

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Trans-Vaginal Sleeve Gastrectomy
Study Start Date : October 2008
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Group/Cohort Intervention/treatment
Transvaginal NOTES sleeve gastrectomy
Transvaginal NOTES sleeve gastrectomy
Procedure: Transvaginal NOTES sleeve gastrectomy
transvaginal NOTES sleeve gastrectomy



Primary Outcome Measures :
  1. To assess outcomes related to the transvaginal NOTES approach to laparoscopic sleeve gastrectomy (through data collection). [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. To assess pain associated with the transvaginal NOTES approach to laparoscopic sleeve gastrectomy (through data collection). [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01402505


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

Locations
United States, California
University of California, San Diego Recruiting
San Diego, California, United States, 92103
Principal Investigator: Santiago Horgan, M.D., FACS         
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Santiago Horgan, M.D., FACS UCSD

Responsible Party: Santiago Horgan, Professor of Surgery, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01402505     History of Changes
Other Study ID Numbers: 081036, 141812
First Posted: July 26, 2011    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018

Keywords provided by Santiago Horgan, University of California, San Diego:
obesity
sleeve gastrectomy
transvaginal NOTES