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NCT02973009: TROCSLEEVE
Impact of the Systematic Closure of the Epigastric Trocar on Postoperative Incisional Hernia After Sleeve Gastrectomy Rate of First Intention. Monocentric Study, Before / After Prospective.
trial in Bariatric Surgery. Withdrawn.
16 May 2017
Quick facts
| Lead sponsor | Centre Hospitalier Universitaire, Amiens |
|---|---|
| Status | Withdrawn |
| Study type | OBSERVATIONAL |
| Start date | 16 May 2017 |
| Primary completion | 16 May 2017 |
| Estimated completion | 16 May 2017 |
Conditions studied
- Bariatric Surgery — all drugs for Bariatric Surgery →
Sponsor
Centre Hospitalier Universitaire, Amiens
Who can join
18 and older, any sex, with Bariatric Surgery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The Sleeve Gastrectomy (SG) is a bariatric surgery procedure performed by laparoscopic booming in recent years. This is an effective intervention on weight loss over the long term with few early postoperative complications and low morbidity in the long term. Obesity is considered as a risk factor for hernia full after surgery by laparoscopy with a relative risk of 29% in connection with cholecystectomy. Several series showed a rupture rate on trocar from 0 to 0.7%, but each time with a clinical evaluation. Recently, it was shown eventrations rate between 26 and 38% under the Roux-en-Y gastric bypass with a rupture rate increased on epigastric trocar. The assessment in the context of this series was ultrasound. Recent data suggest that the absence of closure of the epigastric trocar of 12mm through an SG of first intention was associated with a hernia rate of 17% with a scannographic evaluation. Also, recently, Tabone suggests that the systematic closure of the epigastric trocar site would not be as effective as lateralize inserting the trocar from the white line of the abdomen. Change the positioning of this trocar induce an additional difficulty in handling instruments for the realization of the SG with an désaxassion instruments, a conflict between the instruments for the realization of the SG and the optical laparoscopy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02973009
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT02973009 (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 Centre Hospitalier Universitaire, Amiens
- Last refreshed: 15 July 2020
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/NCT02973009.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing