NCT01554553

Brief Summary

The purpose of this study is to evaluate the superiority of posterior crural repair during sleeve gastrectomy over no repair in decreasing the incidence of symptomatic and clinical reflux disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2012

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 15, 2012

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2018

Completed
Last Updated

May 25, 2023

Status Verified

May 1, 2023

Enrollment Period

6.6 years

First QC Date

February 24, 2012

Last Update Submit

May 24, 2023

Conditions

Obesity

Keywords

Sleeve gastrectomyPosterior crural repair

Outcome Measures

Primary Outcomes (1)

  • Change in GERD / GSRS Quality of Life Questionnaire

    The primary outcome of the study will be the patients' self-assessment of their reflux symptoms as reported with the GSRS quality of life questionnaire that was specifically designed to be used as an outcome measure in clinical trials of intervention in GERD. The final primary outcome will be measured every year to assess allieviation or change of reflux sysmtpms over time and to ensure there is no reoccurence of symptoms.

    1 questionnaire pre-operatively, and then every 3 months for the 1st year, every 6 months until the third year, and every 12 months until 6 years.

Study Arms (2)

Posterior crural repair

EXPERIMENTAL
Procedure: Posterior crural repair

No posteriorcrural repair

NO INTERVENTION

Interventions

Posterior crural repairPROCEDURE

All patients receive gastrectomy, however patients randomized to the experimental arm will also receive posterior crural repair to determine if this will reduce GERD post sleeve gastrectomy.

Also known as: gastric sleeve with crural repair
Posterior crural repair

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The subject is between the ages of 21 and 65
  • The subject is able to provide informed consent
  • The subject is able and willing to comply with the study protocol
  • Patients are will to refrain from the use of specified antacid medications such as PPIs (e.g. Nexium, Prilosec, Omeprazole, etc) or H2 blockes (e.g. Pepcid, Zantac, etc)
  • The subjects meets the requirement for bariatric surgery as defined by the 1991 NIH consensus on bariatric surgery
  • BMI ≥40 or BMI = 35-39 with one or more obesity-related comorbidities.
  • Patients should have attempted, and failed, several structured methods of weight loss The subject is approved to have a sleeve gastrectomy

You may not qualify if:

  • The subject is not able to provide informed consent
  • The subject is not willing to comply with the study protocol
  • The subject has had previous foregut (stomach) surgery
  • The subject has evidence of a gastric tumor, ulcer, or other abnormalities at the time of EGD that would preclude them from having a sleeve gastrectomy
  • Severe esophagitis or Barrett's esophagus will exclude them from the study
  • The surgeon concludes that the patient is not a candidate for sleeve gastrectomy based on his clinical judgment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minimally Invasive Surgeons of Texas (MIST), Bariatric Clinic

Houston, Texas, 77401, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Brad Snyder, MD

    UT Medical School at Houston, Dept. of Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD - Principal Investigator

Study Record Dates

First Submitted

February 24, 2012

First Posted

March 15, 2012

Study Start

January 1, 2012

Primary Completion

August 10, 2018

Study Completion

August 10, 2018

Last Updated

May 25, 2023

Record last verified: 2023-05

Locations

US(1)