Effects of weight loss after bariatric surgery on spine health in obese patients
Prospective Study on the Consequences of Weight Loss After Bariatric Surgery on Obese Patients' Spine : Effects on Low Back Pain, Sagittal Alignment and Lipomatosis.
This study is testing how losing weight after bariatric surgery affects spine health and back pain in obese patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT04893954 on ClinicalTrials.gov |
What this trial studies
This study investigates how significant weight loss following bariatric surgery impacts the spine of obese patients, particularly focusing on low back pain, sagittal alignment, and lipomatosis. Researchers will assess clinical parameters alongside radiological and MRI evaluations to understand the relationship between weight loss and spinal health. The study aims to identify factors that may contribute to either an increase or decrease in back pain after weight loss. By analyzing these effects, the study seeks to provide insights into the management of back pain in post-bariatric surgery patients.
Who should consider this trial
Good fit: Ideal candidates are obese patients over 18 years old who have undergone bariatric surgery and are being followed up at Pompidou's Hospital.
Not a fit: Patients with a history of spine surgery or those who have experienced postoperative complications from bariatric surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for low back pain in obese patients after weight loss.
How similar studies have performed: While the relationship between obesity and back pain has been noted, this specific investigation into the effects of weight loss on spinal health is relatively novel and has not been extensively studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Paris
- Hopital Européen Georges Pompidou — Paris, France (Recruiting)
Study contacts
- Principal investigator: Emmanuelle FERRERO, MD, PHD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Emmanuelle FERRERO, MD, PHD
- Email: emmanuelle.ferrero@aphp.fr
- Phone: 01 56 09 32 50
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.