Transvaginal NOTES Sleeve Gastrectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by University of California, San Diego.
Recruitment status was  Recruiting
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

July 21, 2011
July 25, 2011
October 2008
September 2014   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01402505 on ClinicalTrials.gov Archive Site
Not Provided
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 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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Obesity
Procedure: Transvaginal NOTES sleeve gastrectomy
transvaginal NOTES sleeve gastrectomy
Experimental: 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
10
September 2014
September 2014   (final data collection date for primary outcome measure)

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.

Female
18 Years to 64 Years
No
Contact: Sarah Lazar, MPH 619-471-0447 misresearch@ucsd.edu
Contact: Cece Echon, RN, MSN 619-471-0447 misresearch@ucsd.edu
United States
 
NCT01402505
081036
Yes
Santiago Horgan, M.D., University of California, San Diego
University of California, San Diego
Not Provided
Principal Investigator: Santiago Horgan, M.D. UCSD
University of California, San Diego
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP