Prospective Study on the Consequences of Weight Loss After Bariatric Surgery on Obese Patients' Spine.

Assistance Publique - Hôpitaux de Paris80 enrolled

Overview

The purpose of this study is to determine how an important weight loss after bariatric surgery affects obese patients ' spine, and the effects it has on low back pain, sagittal alignment and lipomatosis .

Obesity and back pain are massive public health problems, and the relationship between the two has not been described and studied. However, the investigators have also observed that many ex-obese patients still suffer from back and leg pain after an important weight loss. The aim of this study is to measure the effect of weight loss on back pain, and to find out what parameters can explain such modifications (increasing or decreasing back pain). The investigators will study clinical parameters, as well as radiological (to measure the effect of weight loss on spine sagittal alignment) and MRI (to measure lipomatosis, which is a fat epidural accumulation, responsible for nerve compression and therefore back and leg pain).

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Low Back Pain in Obese Patients After Important Weight Loss

Interventions

Full Spine RadiographyDIAGNOSTIC_TEST

Full Spine Radiography

Lumbar spine MRIDIAGNOSTIC_TEST

Lumbar spine MRI

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age \> 18 years old * BMI \> 40 or BMI \> 35 with comorbidities due to obesity ( criteria for bariatric surgery) * Follow up in Pompidou's Hospital Nutrition service * Bariatric surgery intervention ( Sleeve gastrectomy or By pass) * Follow up possible for one year or more * Being covered by French social insurance * Consent to participate in the study Exclusion Criteria: * History of spine surgery * Bariatric surgery postoperative complication * Non mastering of french language * MRI contraindication * Patient under legal protection ( e.g. guardianship)

Locations (1)

Hopital Européen Georges Pompidou

Paris, France

RECRUITING

Outcomes

Primary Outcomes

Oswestry disability Index (ODI)

Clinical score to evaluate low back pain vs Preoperative evaluation

Time frame: 1 year postoperative

Oswestry disability Index (ODI)

Clinical score to evaluate low back pain vs Preoperative evaluation

Time frame: 2 years postoperative

Secondary Outcomes

Oswestry disability Index (ODI)

Clinical score to evaluate low back pain vs Preoperative evaluation

Time frame: 6 months postoperative

Sagittal alignment

Radiologic measurement of spine parameters vs Preoperative evaluation

Time frame: 6 months postoperative

Sagittal alignment

Radiologic measurement of spine parameters vs Preoperative evaluation

Time frame: 1 year postoperative

Sagittal alignment

Radiologic measurement of spine parameters vs Preoperative evaluation

Time frame: 2 years postoperative

Disc degeneration

MRI evaluation vs Preoperative evaluation

Time frame: 6 months postoperative

Disc degeneration

MRI evaluation vs Preoperative evaluation

Time frame: 1 year postoperative

Disc degeneration

Central Contacts

Emmanuelle FERRERO, MD, PHD

CONTACT

01 56 09 32 50 emmanuelle.ferrero@aphp.fr

Marie BENHAMMANI-GODARD

CONTACT

00 33 1 58 41 11 90 marie.godard@aphp.fr

Data from ClinicalTrials.gov

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