Preoperative PPI in Sleeve Gastrectomy

Minia University

Status and phase: Completed; Phase 2

Conditions: Morbid Obesity

Treatments: Combination Product: sleeve + preoperative Placebo; Combination Product: sleeve + preoperative PPI

Study type: Interventional

Funder types: Other

Identifiers

NCT03305432

fac.med.043

Details and patient eligibility

About

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

Full 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

Enrollment: 120 patients

Sex: All

Ages: 16 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups

PPI group

Experimental group

Description:

take preoperative PPI for 10 days

Treatment:

Combination Product: sleeve + preoperative PPI

Control group

Active Comparator group

Description:

take placebo for for 10 days preoperative

Treatment:

Combination Product: sleeve + preoperative Placebo