Durability of Weight Loss After Bariatric Surgery

Completed

• Conditions: Obesity
• Interventions: Procedure: Bariateric surgery

• Registration Number: NCT04650373
• Lead Sponsor: Al-Azhar University

Brief Summary

The present study is a retrospective cohort study. Patients older than 18 years of age and underwent Roux-en-Y gastric bypass (RYGB) surgical treatment during the period from 2014 to 2019 and paired severely overweight controls who had no longer gone through bariatric surgery. Patients having BMI (Body Mass Index) much lower than 35 (calculated as the weight (kilograms) / length2 (meters)), a base line diagnosis taken into consideration a medical exclusion for surgical treatment died in one year of surgical operation and missed statistics at scientific information had been excluded from the study. The primary final results of the study was the weight-change percentage at follow-up in comparison with baseline one and the clinical events after surgery.

Detailed Description

This is a retrospective cohort study. The sample size of our study includes one hundred case older than 18 years of age and underwent RYGB surgical treatment during the period from 2014 to 2019 and paired severely overweight controls who had no longer gone through bariatric surgery. Patients having BMI (Body Mass Index) much lower than 35 (calculated as the weight (kilograms) / length2 (meters)), a base line diagnosis taken into consideration a medical exclusion for surgical treatment, died in one year of surgical operation and missed statistics at scientific information had been excluded from the study. Data was collected taking in to account each patient history (age, sex, length, weight, BMI, occupation, marital status, and comorbidities) and weight record in every visit from measurements statistics. Outcomes: The primary final results of the study was the weight-change percentage at follow-up in comparison with baseline one. The secondary effects including the clinical events after surgery, micronutrient levels, incidence of diabetes, hypertension, and dyslipidemia.

Study Timeline

• Study Start: 2014-01-17
• Primary Completion: 2019-12-01
• Study Completion: 2020-01-25
• Study First Submitted: 2020-11-24
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-01
• Last Update Submitted: 2020-12-01
• Study First Posted: 2020-12-02
• Last Update Posted: 2020-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients equal or over 18 years old
• BMI more than 40
• Complete follow up

Exclusion Criteria

• No complete follow up
• Age less than 18 or more than 80

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgical management	Bariateric surgery	Underwent bariatric surgery

Primary Outcome Measures

Name	Time	Method
weight-change percentage at follow-up	1 year	Weight loss or gain in kilogram after surgery is evaluated.
Clinical Events, Diabetes Miletus	1 year	The secondary effects of the clinical events after surgery including incidence of diabetes disease (DM) is measured using the blood glucose level. Fasting blood glucose level more than 7.1 mmol/L is considered posutive for DM
Clinical Events, Hypertension	1 year	Arterial blood pressure is followed up regularly, three consequences increase of the blood pressure more than 140 mm Hg systolic and 90 mm Hg diastolic, is positive for hypertension

Trial Locations

Locations (1)

Abdulkarim Hasan; 🇪🇬 Cairo, Egypt