NCT01402505

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 26, 2011

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

10 years

First QC Date

July 21, 2011

Last Update Submit

March 28, 2020

Conditions

Obesity

Keywords

obesitysleeve gastrectomytransvaginal NOTES

Outcome Measures

Primary Outcomes (1)

  • To assess outcomes related to the transvaginal NOTES approach to laparoscopic sleeve gastrectomy (through data collection).

    1 year

Secondary Outcomes (1)

  • To assess pain associated with the transvaginal NOTES approach to laparoscopic sleeve gastrectomy (through data collection).

    1 year

Study Arms (1)

Transvaginal NOTES sleeve gastrectomy

Transvaginal NOTES sleeve gastrectomy

Procedure: Transvaginal NOTES sleeve gastrectomy

Interventions

Transvaginal NOTES sleeve gastrectomyPROCEDURE

transvaginal NOTES sleeve gastrectomy

Transvaginal NOTES sleeve gastrectomy

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients between the ages of 18-75 who present in the UC San Diego Surgical Specialties clinic and have been cleared by the Bariatric and Metabolic Institute (BMI) team for bariatric surgery will be evaluated for participation in this trial. If the inclusion and exclusion criteria are met, the patients will be offered participation in the trial.

You may qualify if:

  • Diagnosis of morbid obesity BMI \> 40
  • Female, age 18-75
  • Mentally competent to give informed consent
  • Scheduled to undergo a transvaginal NOTES sleeve gastrectomy

You may not qualify if:

  • Pregnant women
  • BMI \< 40

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Santiago Horgan, M.D., FACS

    UCSD

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

July 21, 2011

First Posted

July 26, 2011

Study Start

October 1, 2008

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

March 31, 2020

Record last verified: 2020-03

Locations

US(1)