View Clinical Trial (Medical Research Study)
Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Trans-Vaginal Sleeve Gastrectomy
| City: |
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San Diego |
| State: |
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California |
| Zip Code: |
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92103 |
| Conditions: |
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Obesity |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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.
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| NCT ID: |
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NCT01402505 |
| Primary Contact: |
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Principal Investigator
Santiago Horgan, M.D.
UCSD
Sarah Lazar, MPH
Phone: 619-471-0447
Email: misresearch@ucsd.edu
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| Backup Contact: |
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Email: misresearch@ucsd.edu
Cece Echon, RN, MSN
Phone: 619-471-0447
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| Location Contact: |
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San Diego, California 92103
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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