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Transvaginal NOTES Sleeve Gastrectomy

This study is currently recruiting participants.
Verified July 2011 by University of California, San Diego
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01402505
First received: July 21, 2011
Last updated: July 25, 2011
Last verified: July 2011
History of Changes
  Purpose

This is a pilot study looking at a novel surgical approach for a commonly performed laparoscopic surgery: sleeve gastrectomy. The aims of this study are to assess the safety and efficacy of a novel approach to minimally invasive surgical techniques, and to assess pain associated with the transvaginal NOTES approach.


Condition Intervention Phase
Obesity
 Procedure: Transvaginal NOTES sleeve gastrectomy
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Trans-Vaginal Sleeve Gastrectomy

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Safety and efficacy assessment based on patient reported outcomes and the number of adverse events. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Pain and temperature assessment based on a log post-operatively. [ 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.


Estimated Enrollment: 10
Study Start Date: October 2008
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transvaginal NOTES sleeve gastrectomy
Transvaginal NOTES sleeve gastrectomy
 Procedure: Transvaginal NOTES sleeve gastrectomy
transvaginal NOTES sleeve gastrectomy

Detailed Description:

Subjects will be female between the ages of 18-64 who present to the general surgery clinic and are subsequently diagnosed with morbid obesity. Generally, sleeve gastrectomy is reserved for higher BMI patients (BMI > 40) as patients with lower BMI's are more likely to be successful with a gastric band. Following diagnosis, investigators will be contacted by the surgical consult team to determine if a patient meets criteria for the study. If the patient satisfies the listed criteria then researchers will present study information and offer participation.

Subjects will undergo a laparoscopic sleeve gastrectomy, endoscopically assisted via the vagina. The portion of the stomach that is removed will be removed via an endoscope through the vagina.

Post op treatment will follow regular standard of care following a laparoscopic sleeve gastrectomy.

Post-op complications such as intra-abdominal abscess will be handled in the same fashion as any post op complication in laparoscopic sleeve. Subjects will be treated and insurance will be billed.

The patient will be followed in the UCSD surgery clinic per standard of care.

Any other treatments will be provided as needed. All visits shall be covered by subjects insurance.

Subjects will be given a log with which to capture pain and temperature for 7 days post-op for their physician. Subjects will be seen per the physician's discretion.

In addition to the above procedures and follow-up, we will assess pain and sexual function using a standardized sexual function questionnaire at baseline/screening and at approximately 6 months post-op. Subjects will complete the questionnaire after signing the informed consent form prior to surgery, and again at their 6 month post-op visit.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria for Sleeve Gastrectomy - Transvaginal Approach

  1. Females between the ages of 18-64
  2. Clinical diagnosis of morbid obesity BMI > 40
  3. Approval from Internal Medicine, Dietician, and Psychologist
  4. ASA Classification 1 or 2

Exclusion criteria for Sleeve Gastrectomy - Transvaginal Approach

  1. Pregnant women (need to have negative icon in ER)
  2. BMI < 40
  3. Patients who are taking immunosuppressive medications or are immunocompromised
  4. Patients with evidence of an abdominal abscess or mass
  5. Patients who have a history of prior open abdominal surgery or prior transvaginal surgery. Patients with prior laparoscopic surgery will be included. Patients with prior pelvic surgery are included.
  6. Patients who endorse a history of ectopic pregnancy, pelvic inflammatory disease (PID), or severe endometriosis
  7. Patients with diffuse peritonitis on clinical exam
  8. Previous trauma to the perineal area
  9. Patients on blood thinners or aspirin or abnormal blood coagulation tests

Subjects undergoing sleeve gastrectomy will be evaluated by Dr. Horgan in the Center for the Treatment of Obesity (CTO) clinic, and this will be an elective, non-emergent procedure. These subjects will be offered voluntary participation in the study at the time of their preoperative screening visit.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01402505

Contacts
Contact: Sarah Lazar, MPH 619-471-0447 misresearch@ucsd.edu
Contact: Cece Echon, RN, MSN 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.            
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Santiago Horgan, M.D. UCSD
  More Information

No publications provided

Responsible Party: Santiago Horgan, M.D., University of California, San Diego
ClinicalTrials.gov Identifier: NCT01402505     History of Changes
Other Study ID Numbers: 081036
Study First Received: July 21, 2011
Last Updated: July 25, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013