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

A

Assistance Publique - Hôpitaux de Paris

Status

Enrolling

Conditions

Low Back Pain in Obese Patients After Important Weight Loss

Treatments

Diagnostic Test: Lumbar spine MRI
Diagnostic Test: Full Spine Radiography

Study type

Interventional

Funder types

Other

Identifiers

NCT04893954
APHP201602

Details and patient eligibility

About

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 .

Full description

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).

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

80 participants in 1 patient group

Obese patients
Other group
Treatment:
Diagnostic Test: Full Spine Radiography
Diagnostic Test: Lumbar spine MRI

Trial contacts and locations

1

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Central trial contact

Marie BENHAMMANI-GODARD; Emmanuelle FERRERO, MD, PHD

Data sourced from clinicaltrials.gov

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