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NCT04879667
Endoscopic Management Of Refractory Gastro-cutaneous Fistula After Laparoscopic Sleeve Gastrectomy l
NA trial testing endoscopic management of gastrocutaneous fistula after laparoscopic sleeve gastrectomy in Bariatric Surgery Candidate in 30 participants. Completed in 1 April 2021.
1 March 2021
Quick facts
| Lead sponsor | Zagazig University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 December 2019 |
| Primary completion | 1 March 2021 |
| Estimated completion | 1 April 2021 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- endoscopic management of gastrocutaneous fistula after laparoscopic sleeve gastrectomy
Conditions studied
- Bariatric Surgery Candidate — all drugs for Bariatric Surgery Candidate →
Sponsor
Zagazig University
Who can join
Eligibility, any sex, with Bariatric Surgery Candidate. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study included patients who were admitted to investigators' center to do laparoscopic sleeve gastrectomy and complicated by gastro-cutaneous fistula . Cases were collected in the period from December 2019 to march 2021. The study was approved by the research and Ethics committee of investigators' University .a written informed consent was obtained from all participating patients after explaining to them all the study procedures with its benefits and hazards. the work has been carried out in accordance with the code of ethics of the world medical association ( Declaration of Helsinki ) for studies involving humans .the sample size was calculated using open Epi program using the following data ; confidence interval 95% , power of test 80% , ratio of unexposed/exposed 1, percent of patients with successful management of refractory gastro-cutaneous fistula by surgical intervention 50% and those with successful management by endoscopy 99% , odds ratio 99%, and risk ratio 2 , so the calculated sample size equal 30 patients divided into two equal groups. Group (1) included 15 patients managed by surgical intervention , group (2) included 15 patients managed by endoscopic intervention.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Endoscopic management of refractory leak and gastro-cutaneous fistula after laparoscopic sleeve gastrectomy: a randomized controlled trial.
Negm S, Mousa B, Shafiq A, Abozaid M, et al · · 2023 · cited 8× · PMID 36326931 · DOI 10.1007/s00464-022-09748-z
Verify or expand the search:
- PubMed search for NCT04879667
- 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 NCT04879667 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Zagazig University
- Last refreshed: 10 May 2021
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/NCT04879667.
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