Transvaginal NOTES Sleeve Gastrectomy

Obesity Clinical Trial

Official title:

Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Trans-Vaginal Sleeve Gastrectomy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01402505
• Other study ID #: 081036, 141812
• Status: Withdrawn
• Start date: October 2008
• Est. completion date: October 2018

Study information

• Verified date: March 2020
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective chart review/data collection study of natural orifice translumenal endoscopic surgery (NOTES) for sleeve gastrectomy, that will include questionnaires administered throughout the study. Subjects enrolled will be those intending to have a transvaginal NOTES sleeve gastrectomy. Data will be collected and reviewed through 12 months post-op.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion:

1. Diagnosis of morbid obesity BMI > 40

2. Female, age 18-75

3. Mentally competent to give informed consent

4. Scheduled to undergo a transvaginal NOTES sleeve gastrectomy

Exclusion:

1. Pregnant women

2. BMI < 40

Related Conditions & MeSH terms

• Obesity

Intervention

Procedure:
• Transvaginal NOTES sleeve gastrectomy
transvaginal NOTES sleeve gastrectomy

Locations

Country	Name	City	State
United States	University of California, San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess outcomes related to the transvaginal NOTES approach to laparoscopic sleeve gastrectomy (through data collection).		1 year
Secondary	To assess pain associated with the transvaginal NOTES approach to laparoscopic sleeve gastrectomy (through data collection).		1 year