Transvaginal NOTES 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.
|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|
- 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.
|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)|
Experimental: Transvaginal NOTES sleeve gastrectomy
Transvaginal NOTES sleeve gastrectomy
Procedure: Transvaginal NOTES sleeve gastrectomy
transvaginal NOTES sleeve gastrectomy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01402505
|Contact: Sarah Lazar, MPHemail@example.com|
|United States, California|
|University of California, San Diego||Recruiting|
|San Diego, California, United States, 92103|
|Principal Investigator: Santiago Horgan, M.D.|
|Principal Investigator:||Santiago Horgan, M.D.||UCSD|