Back to resultsPreoperative PPI in Sleeve Gastrectomy
Primary Purpose
Morbid Obesity
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
sleeve + preoperative PPI
sleeve + preoperative Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Morbid Obesity
Eligibility Criteria
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
Sites / Locations
- Faculty of medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PPI group
Control group
Arm Description
take preoperative PPI for 10 days
take placebo for for 10 days preoperative
Outcomes
Primary Outcome Measures
early postoperative bleeding and leak
early postoperative complications, including bleeding from stable line either intragastric or intraperitoneal and early leak from stable line
Secondary Outcome Measures
operative time
time taken from skin incision to closure
microscopic picture of the removed stomach
histological examination to detect the presence of inflammation in of the removed part of the stomach
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03305432
Brief Title
Preoperative PPI in Sleeve Gastrectomy
Official Title
Routine Preoperative PPI in Sleeve Gastrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
August 20, 2018 (Actual)
Study Completion Date
August 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
he purpose of this study is to study the effect of preoperative PPI in the early outcome of sleeve gastrectomy
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PPI group
Arm Type
Experimental
Arm Description
take preoperative PPI for 10 days
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
take placebo for for 10 days preoperative
Intervention Type
Combination Product
Intervention Name(s)
sleeve + preoperative PPI
Intervention Description
sleeve + preoperative PPI
Intervention Type
Combination Product
Intervention Name(s)
sleeve + preoperative Placebo
Intervention Description
sleeve + preoperative Placebo
Primary Outcome Measure Information:
Title
early postoperative bleeding and leak
Description
early postoperative complications, including bleeding from stable line either intragastric or intraperitoneal and early leak from stable line
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
operative time
Description
time taken from skin incision to closure
Time Frame
5 hours
Title
microscopic picture of the removed stomach
Description
histological examination to detect the presence of inflammation in of the removed part of the stomach
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Faculty of medicine
City
Minya
ZIP/Postal Code
61511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Preoperative PPI in Sleeve Gastrectomy
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