NCT04893954 Prospective Study on the Consequences of Weight Loss After Bariatric Surgery on Obese Patients' Spine.
| NCT ID | NCT04893954 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Low Back Pain in Obese Patients After Important Weight Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2021-06-03 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2021-06-03 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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)
Contact & Investigator
Emmanuelle FERRERO, MD, PHD
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT04893954 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Low Back Pain in Obese Patients After Important Weight Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04893954 currently recruiting?
Yes, NCT04893954 is actively recruiting participants. Contact the research team at emmanuelle.ferrero@aphp.fr for enrollment information.
Where is the NCT04893954 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT04893954 clinical trial?
NCT04893954 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Emmanuelle FERRERO, MD, PHD at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 80 participants.