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Completed

NCT Number: NCT03305432

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

Completed

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Key information

Conditions

Morbid Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

16 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of medicine

Minya, 61511, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sleeve + preoperative PPI

Combination Product

sleeve + preoperative PPI

sleeve + preoperative Placebo

Combination Product

sleeve + preoperative Placebo

Primary outcomes

  1. 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

Secondary outcomes

  1. operative time

    Time frame: 5 hours

    time taken from skin incision to closure

  2. 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

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

Routine Preoperative PPI in Sleeve Gastrectomy

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 10, 2017
Registry last updated
Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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