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

Last updated: January 17, 2025
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Weight Loss

Diabetes Prevention

Treatment

Full Spine Radiography

Lumbar spine MRI

Clinical Study ID

NCT04893954
APHP201602
  • Ages > 18
  • All Genders

Study Summary

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 .

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age > 18 years old

  • BMI > 40 or BMI > 35 with comorbidities due to obesity ( criteria for bariatricsurgery)

  • 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

Exclusion Criteria:

  • History of spine surgery

  • Bariatric surgery postoperative complication

  • Non mastering of french language

  • MRI contraindication

  • Patient under legal protection ( e.g. guardianship)

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Full Spine Radiography
Phase:
Study Start date:
June 03, 2021
Estimated Completion Date:
September 30, 2029

Study 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).

Connect with a study center

  • Hopital Européen Georges Pompidou

    Paris, 75015
    France

    Active - Recruiting

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