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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04844320
Other study ID # DR. ANIL ERGIN
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 1, 2021
Est. completion date December 1, 2021

Study information

Verified date April 2021
Source Fatih Sultan Mehmet Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 90
Est. completion date December 1, 2021
Est. primary completion date September 1, 2021
Accepts healthy volunteers No
Gender All
Age group 16 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Cobb angle measurements
PA Chest x-rays will be taken in all patients in the preoperative, postoperative 1st year and 2nd year

Locations

Country Name City State
Turkey Anil Ergin Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Fatih Sultan Mehmet Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cobb angle measurements Cobb angle measurements will be made and recorded by an expert radiologist from the PA Chest X-ray. 2 years
Secondary % EWL measurements % EWL measurements will be made in all patients 1 and 2 years after laparoscopic sleeve gastrectomy 2 years
Secondary Patient satisfaction 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
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