Durability of Weight Loss After Bariatric Surgery

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04650373
• Other study ID #: AUH20-011
• Status: Completed
• Start date: January 17, 2014
• Est. completion date: January 25, 2020

Study information

• Verified date: December 2020
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 25, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Procedure:
• Bariateric surgery
Adult patients underwent RYGB surgical treatment during the period from 2014 to 2019

Locations

Country	Name	City	State
Egypt	Abdulkarim Hasan	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight-change percentage at follow-up	Weight loss or gain in kilogram after surgery is evaluated.	1 year
Primary	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
Primary	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