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

  • STATUS
    Recruiting
  • End date
    Dec 22, 2024
  • participants needed
    80
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 22 March 2022

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 .

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).

Details
Condition Low Back Pain in Obese Patients After Important Weight Loss
Treatment Full Spine Radiography, Lumbar spine MRI
Clinical Study IdentifierNCT04893954
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

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)
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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