Preoperative PPI in Sleeve Gastrectomy

Morbid Obesity Clinical Trial

Official title:

Routine Preoperative PPI in Sleeve Gastrectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03305432
• Other study ID #: fac.med.043
• Status: Completed
• Phase: Phase 2
• Start date: January 15, 2018
• Est. completion date: August 20, 2018

Study information

• Verified date: September 2018
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 20, 2018
• Est. primary completion date: August 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Combination Product:
• sleeve + preoperative PPI
sleeve + preoperative PPI
• sleeve + preoperative Placebo
sleeve + preoperative Placebo

Locations

Country	Name	City	State
Egypt	Faculty of medicine	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	early postoperative bleeding and leak	early postoperative complications, including bleeding from stable line either intragastric or intraperitoneal and early leak from stable line	2 weeks
Secondary	operative time	time taken from skin incision to closure	5 hours
Secondary	microscopic picture of the removed stomach	histological examination to detect the presence of inflammation in of the removed part of the stomach	2 weeks