Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Transvaginal NOTES Sleeve Gastrectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University of California, San Diego
Information provided by (Responsible Party):
Santiago Horgan, University of California, San Diego Identifier:
First received: July 21, 2011
Last updated: December 1, 2014
Last verified: December 2014

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
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:

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: October 2018
Estimated Primary Completion Date: October 2018 (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.


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

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
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 identifier: NCT01402505

Contact: Sarah Lazar, MPH 619-471-0447

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
Principal Investigator: Santiago Horgan, M.D. UCSD
  More Information

No publications provided

Responsible Party: Santiago Horgan, Professor of Surgery, University of California, San Diego Identifier: NCT01402505     History of Changes
Other Study ID Numbers: 081036, 141812
Study First Received: July 21, 2011
Last Updated: December 1, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Body Weight
Nutrition Disorders
Signs and Symptoms processed this record on February 25, 2015