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

NCT04844320 | Unknown

• 1 other identifier: DR. ANIL ERGIN
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Morbid; Back Pain; Scoliosis

Keywords

Morbid obesity; cobb angle; laparoscopic sleeve gastrectomy; scoliosis

Outcome Measures

Primary Outcomes (1)

• Cobb angle measurements

  Cobb angle measurements will be made and recorded by an expert radiologist from the PA Chest X-ray.

  2 years

Secondary Outcomes (2)

• % EWL measurements

  2 years

• Patient satisfaction

  2 years

Study Arms (3)

> 50 %EWL

ACTIVE COMPARATOR

Postoperative weight loss in first year \> 50 % EWL

Diagnostic Test: Cobb angle measurements

50 - 25 % EWL

ACTIVE COMPARATOR

Postoperative weight loss in first year 25 - 50 % EWL

Diagnostic Test: Cobb angle measurements

< 25 % EWL

ACTIVE COMPARATOR

Postoperative weight loss in first year \< 25 % EWL

Diagnostic Test: Cobb angle measurements

Interventions

Cobb angle measurements DIAGNOSTIC_TEST

PA Chest x-rays will be taken in all patients in the preoperative, postoperative 1st year and 2nd year

50 - 25 % EWL; < 25 % EWL; > 50 %EWL

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Anıl Ergin

Istanbul, 34734, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity, Morbid; Back Pain; Scoliosis

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. Anil Ergin

Model Details: 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.

Study Record Dates

• First Submitted: April 10, 2021
• First Posted: April 14, 2021
• Study Start: April 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)