Durability of Weight Loss After Bariatric Surgery

Long-term Durability of Weight Loss After Bariatric Surgery; A Retrospective Study

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Procedure: Bariateric 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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11884
    • Abdulkarim Hasan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients in Al-Azhar University hospital for overweight or obesity problems

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surgical management; Underwent bariatric surgery	Procedure: Bariateric surgery; Adult patients underwent RYGB surgical treatment during the period from 2014 to 2019
Non-surgical management; Patients treated medically

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight-change percentage at follow-up	Weight loss or gain in kilogram after surgery is evaluated.	1 year
Clinical Events, Diabetes Miletus	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	1 year
Clinical Events, Hypertension	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	1 year

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Study Chair: Mohamad Baheeg, Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2014
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): January 25, 2020

Study Registration Dates

• First Submitted: November 24, 2020
• First Submitted That Met QC Criteria: December 1, 2020
• First Posted (Actual): December 2, 2020

Study Record Updates

• Last Update Posted (Actual): December 2, 2020
• Last Update Submitted That Met QC Criteria: December 1, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Durability; Bariateric surgery
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: AUH20-011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No