THE EFFECT OF FAST WEIGHT EFFICIENCY AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY ON THE COBB ANGLE IN MORBID OBESE PATIENTS

April 10, 2021 updated by: ANIL ERGIN, Fatih Sultan Mehmet Training and Research Hospital

Obesity has become an increasingly common health problem today. In this context, although many anatomical, physiological and metabolic problems arising from obesity in morbid obese patients are tried to be solved in daily practice, it has been proven that eliminating obesity is sufficient in the treatment of many diseases. When we look at the literature, it is known that morbid obesity causes deformation and excessive wear in most body joints. When morbid obesity disappears, it has been shown that the previously existing neck, waist, back and knee pains regress.

The aim of this study is to reveal the Cobb angle change in morbidly obese patients who achieved rapid weight loss after obesity surgery; To investigate the effect of weight loss on vertebral anatomy.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

90 morbidly obese patients who underwent Laparoscopic Sleeve Gastrectomy were included in the study. Cobb angle measurements were made by a radiologist included in the study from the PA chest radiographs of the operated patients in the preoperative period and in the first postoperative year, and they were recorded in a previously prepared database. In addition, in the preoperative period and postoperative first year evaluations of the patients; Patient satisfaction questionnaire in terms of low back pain, back pain, neck pain, and the value in% EWL of weight given after surgery were also recorded in the database.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34734
        • Anıl Ergin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients over the age of 18.
  • Patients with a diagnosis of morbid obesity, body mass index> 40

Exclusion Criteria:

  • Patients who have undergone previous vertebral surgery due to any disease
  • Patients hospitalized for more than 10 days due to postoperative complications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: > 50 %EWL
Postoperative weight loss in first year > 50 % EWL
Diagnostic test: Cobb angle measurements
PA Chest x-rays will be taken in all patients in the preoperative, postoperative 1st year and 2nd year
Active Comparator: 50 - 25 % EWL
Postoperative weight loss in first year 25 - 50 % EWL
Diagnostic test: Cobb angle measurements
PA Chest x-rays will be taken in all patients in the preoperative, postoperative 1st year and 2nd year
Active Comparator: < 25 % EWL
Postoperative weight loss in first year < 25 % EWL
Diagnostic test: Cobb angle measurements
PA Chest x-rays will be taken in all patients in the preoperative, postoperative 1st year and 2nd year

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cobb angle measurements
Time Frame: 2 years
Cobb angle measurements will be made and recorded by an expert radiologist from the PA Chest X-ray.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% EWL measurements
Time Frame: 2 years
% EWL measurements will be made in all patients 1 and 2 years after laparoscopic sleeve gastrectomy
2 years
Patient satisfaction
Time Frame: 2 years
All patients will be given a patient satisfaction questionnaire, which includes the complaints of low back pain, back pain and neck pain, and compares the postoperative and pre-operative processes.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fatih Sultan Mehmet Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

April 10, 2021

First Submitted That Met QC Criteria

April 10, 2021

First Posted (Actual)

April 14, 2021

Study Record Updates

Last Update Posted (Actual)

April 14, 2021

Last Update Submitted That Met QC Criteria

April 10, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DR. ANIL ERGIN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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