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NCT04009356: IVBIA
Impact of Bariatric Surgery in Patients With Morbid Obesity
trial testing bariatric surgical procedures in Obesity, Morbid in 300 participants. Completed in 1 January 2022.
1 August 2021
Quick facts
| Lead sponsor | Central Hospital, Nancy, France |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 300 |
| Start date | 22 January 2020 |
| Primary completion | 1 August 2021 |
| Estimated completion | 1 January 2022 |
| Sites | 1 location across France |
Drugs / interventions tested
- bariatric surgical procedures
Conditions studied
- Obesity, Morbid — all drugs for Obesity, Morbid →
- Anal Incontinence — all drugs for Anal Incontinence →
- Image, Body — all drugs for Image, Body →
Sponsor
Central Hospital, Nancy, France
Who can join
Adults 18 to 65, any sex, with Obesity, Morbid or Anal Incontinence. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The main objective is to compare the prevalence of anal incontinence (AI) before and after bariatric surgery in obese patients. Inclusion: Patients who are scheduled for a bariatric surgical procedure after a multidisciplinary evaluation for about 1 year (following french national recommendations). Primary objective: After inclusion, all patients will fill in a specific self-questionnaire evaluating AI (PFDI-20 score) before surgery and at 6 months after surgery. Investigators will evaluate the prevalence of anal incontinence before and at 6months after surgery using this PFDI- 20 score. In those patients with preoperative anal incontinence (only in patients with 3 positive answers to question n°9,10, and 11 of PFDI-20 score self-questionnaire), a pelvic MRI will be performed before and at 6 months after surgery. Consequently, no further imaging exam will be performed in patients without preoperative anal incontinence (less than 3 positive answers to question n°9,10, and 11), Secondary objectives: * to evaluate the AI severity variation before and at 6 months after bariatric surgery regarding the percentage of postoperative weight loss. * to compare the quality of life (PFIQ-7 score) related to AI day before and at 6 months after bariatric surgery.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04009356
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Central Hospital, Nancy, France trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04009356 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Central Hospital, Nancy, France
- Last refreshed: 9 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04009356.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing