THE EFFECT OF FAST WEIGHT EFFICIENCY AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY ON THE COBB ANGLE IN MORBID OBESE PATIENTS
Primary Purpose
Obesity, Morbid, Back Pain, Scoliosis
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Cobb angle measurements
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Morbid focused on measuring Morbid obesity, cobb angle, laparoscopic sleeve gastrectomy, scoliosis
Eligibility Criteria
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
Sites / Locations
- Anıl Ergin
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
> 50 %EWL
50 - 25 % EWL
< 25 % EWL
Arm Description
Postoperative weight loss in first year > 50 % EWL
Postoperative weight loss in first year 25 - 50 % EWL
Postoperative weight loss in first year < 25 % EWL
Outcomes
Primary Outcome Measures
Cobb angle measurements
Cobb angle measurements will be made and recorded by an expert radiologist from the PA Chest X-ray.
Secondary Outcome Measures
% EWL measurements
% EWL measurements will be made in all patients 1 and 2 years after laparoscopic sleeve gastrectomy
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.
Full Information
NCT ID
NCT04844320
First Posted
April 10, 2021
Last Updated
April 10, 2021
Sponsor
Fatih Sultan Mehmet Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04844320
Brief Title
THE EFFECT OF FAST WEIGHT EFFICIENCY AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY ON THE COBB ANGLE IN MORBID OBESE PATIENTS
Official Title
THE EFFECT OF FAST WEIGHT EFFICIENCY AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY ON THE COBB ANGLE IN MORBID OBESE PATIENTS
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fatih Sultan Mehmet Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid, Back Pain, Scoliosis
Keywords
Morbid obesity, cobb angle, laparoscopic sleeve gastrectomy, scoliosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study was designed to include 3 groups of 30 patients and a total of 90 patients. 90 patients who underwent laparoscopic sleeve gastrectomy will be divided into 3 groups according to their postoperative weight gain. The first group will include patients who have lost more than 50% EWL postoperative weight, the second group will include patients who have lost 50 to 25% EWL postoperative , and the third group will include patients who have lost less than 25% EWL postoperative.
Patients in these 3 groups will be randomized on www.randomisor.org. In these 3 groups, cobb angle measurements will be made on the PA chest radiographs taken at the preoperative, postoperative 1st year and postoperative 2nd year controls. Patient satisfaction questionnaires will be conducted to compare pre- and postoperative complaints such as low back pain, back pain, and neck pain in all patients. The change in cobb angles will be determined according to the weight loss ratio (% EWL) of the patients.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
> 50 %EWL
Arm Type
Active Comparator
Arm Description
Postoperative weight loss in first year > 50 % EWL
Arm Title
50 - 25 % EWL
Arm Type
Active Comparator
Arm Description
Postoperative weight loss in first year 25 - 50 % EWL
Arm Title
< 25 % EWL
Arm Type
Active Comparator
Arm Description
Postoperative weight loss in first year < 25 % EWL
Intervention Type
Diagnostic Test
Intervention Name(s)
Cobb angle measurements
Intervention Description
PA Chest x-rays will be taken in all patients in the preoperative, postoperative 1st year and 2nd year
Primary Outcome Measure Information:
Title
Cobb angle measurements
Description
Cobb angle measurements will be made and recorded by an expert radiologist from the PA Chest X-ray.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
% EWL measurements
Description
% EWL measurements will be made in all patients 1 and 2 years after laparoscopic sleeve gastrectomy
Time Frame
2 years
Title
Patient satisfaction
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Anıl Ergin
City
Istanbul
ZIP/Postal Code
34734
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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THE EFFECT OF FAST WEIGHT EFFICIENCY AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY ON THE COBB ANGLE IN MORBID OBESE PATIENTS
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