Preoperative PPI in Sleeve Gastrectomy

NCT ID: NCT03305432

Last Updated: 2018-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-15

Study Completion Date

2018-08-20

Brief Summary

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

Detailed Description

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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

Conditions

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Morbid Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PPI group

take preoperative PPI for 10 days

Group Type EXPERIMENTAL

sleeve + preoperative PPI

Intervention Type COMBINATION_PRODUCT

sleeve + preoperative PPI

Control group

take placebo for for 10 days preoperative

Group Type ACTIVE_COMPARATOR

sleeve + preoperative Placebo

Intervention Type COMBINATION_PRODUCT

sleeve + preoperative Placebo

Interventions

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sleeve + preoperative PPI

sleeve + preoperative PPI

Intervention Type COMBINATION_PRODUCT

sleeve + preoperative Placebo

sleeve + preoperative Placebo

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Alaa Mstafa Hassan Sewefy

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of medicine

Minya, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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fac.med.043

Identifier Type: -

Identifier Source: org_study_id

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