NCT03305432

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 10, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

January 15, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2018

Completed
Last Updated

September 5, 2018

Status Verified

September 1, 2018

Enrollment Period

7 months

First QC Date

October 4, 2017

Last Update Submit

September 2, 2018

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • operative time

    5 hours

  • microscopic picture of the removed stomach

    2 weeks

Study Arms (2)

PPI group

EXPERIMENTAL

take preoperative PPI for 10 days

Combination Product: sleeve + preoperative PPI

Control group

ACTIVE COMPARATOR

take placebo for for 10 days preoperative

Combination Product: sleeve + preoperative Placebo

Interventions

sleeve + preoperative PPICOMBINATION_PRODUCT

sleeve + preoperative PPI

PPI group
sleeve + preoperative PlaceboCOMBINATION_PRODUCT

sleeve + preoperative Placebo

Control group

Eligibility Criteria

Age16 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Morbidly obese patient with BMI more than 40 with or without co-morbidity
  • Morbidly obese patient with BMI more than 35 with co-morbidity

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine

Minya, 61511, Egypt

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 4, 2017

First Posted

October 10, 2017

Study Start

January 15, 2018

Primary Completion

August 20, 2018

Study Completion

August 20, 2018

Last Updated

September 5, 2018

Record last verified: 2018-09

Locations

EG(1)