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
  Purpose

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 Intervention Phase
Obesity
Procedure: Transvaginal NOTES sleeve gastrectomy
Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Trans-Vaginal Sleeve Gastrectomy

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 sleeve gastrectomy (through data collection). [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: October 2008
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Transvaginal NOTES sleeve gastrectomy
Transvaginal NOTES sleeve gastrectomy
Procedure: Transvaginal NOTES sleeve gastrectomy
transvaginal NOTES sleeve gastrectomy

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders 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
  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: 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
  More Information

No publications provided

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
Study First Received: July 21, 2011
Last Updated: March 26, 2015
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 01, 2015