Preoperative PPI in Sleeve Gastrectomy

September 2, 2018 updated by: Alaa Mstafa Hassan Sewefy, Minia University

Routine Preoperative PPI in Sleeve Gastrectomy

he purpose of this study is to study the effect of preoperative PPI in the early outcome of sleeve gastrectomy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study 200 morbidly obese patients will be included and will be undergone sleeve gastrectomy. the patients will be randomly assigned into 2 groups, group 1 will be receive PPI preoperative for 10 day and group 2 will not

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Minya, Egypt, 61511
        • Faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 55 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Morbidly obese patient with BMI more than 40 with or without co-morbidity
  • Morbidly obese patient with BMI more than 35 with co-morbidity

Exclusion Criteria:

  • Unfit patients for laparoscopic sleeve gastrectomy
  • patients refuse to share in the study
  • patients that already on PPI due to any indications
  • revisional surgery for obesity
  • previous upper abdominal surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PPI group
take preoperative PPI for 10 days
Combination product: sleeve + preoperative PPI
sleeve + preoperative PPI
ACTIVE_COMPARATOR: Control group
take placebo for for 10 days preoperative
Combination product: sleeve + preoperative Placebo
sleeve + preoperative Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
early postoperative bleeding and leak
Time Frame: 2 weeks
early postoperative complications, including bleeding from stable line either intragastric or intraperitoneal and early leak from stable line
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operative time
Time Frame: 5 hours
time taken from skin incision to closure
5 hours
microscopic picture of the removed stomach
Time Frame: 2 weeks
histological examination to detect the presence of inflammation in of the removed part of the stomach
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 15, 2018

Primary Completion (ACTUAL)

August 20, 2018

Study Completion (ACTUAL)

August 20, 2018

Study Registration Dates

First Submitted

October 4, 2017

First Submitted That Met QC Criteria

October 4, 2017

First Posted (ACTUAL)

October 10, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 5, 2018

Last Update Submitted That Met QC Criteria

September 2, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fac.med.043

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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