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NCT05851794
Intraoperative Endomanometric Laparoscopic Nissen Fundoplication Improves Postoperative Outcomes
NA trial testing endomanometric guided LNF in GERD in 360 participants. Completed in 1 April 2023.
1 April 2020
Quick facts
| Lead sponsor | Zagazig University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 360 |
| Start date | 1 April 2012 |
| Primary completion | 1 April 2020 |
| Estimated completion | 1 April 2023 |
Drugs / interventions tested
- endomanometric guided LNF
- laparoscopic Nissen fundoplication alone
Conditions studied
- GERD — all drugs for GERD →
Sponsor
Zagazig University
Who can join
Adults 18 to 69, any sex, with GERD. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Laparoscopic Nissen fundoplication (LNF) is a surgical intervention for gastroesophageal reflux disease (GERD); however, it can be followed by recurrent symptoms or complications that may affect patient satisfaction. Intraoperative endomanometric evaluation of esophagogastric competence and pressure, combined with LNF in patients with large sliding hiatus hernia (\>5cm) with severe GERD (DeMeester score \>100), is needed.This is a retrospective, multicenter, comparative study. Baseline characteristics, initial reflux symptoms, preoperative and postoperative antacid medication use, postoperative complications (dysphagia and gas bloat syndrome), recurrent symptoms, and satisfaction were collected from a prospective database. Outcomes measures were recurrent reflux symptoms, postoperative side-effects, and satisfaction with surgery. Quantitative data were compared between the studied groups using the independent t-test or Mann-Whitney U test for normally and non-normally distributed numerical variables, respectively
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Intraoperative endomanometric laparoscopic Nissen fundoplication improves postoperative outcomes in large sliding hiatus hernias with severe gastroesophageal reflux disease: a retrospective cohort study.
Habeeb TAAM, Hussain A, Podda M, Aiolfi A, et al · · 2023 · cited 3× · PMID 37566907 · DOI 10.1097/js9.0000000000000659
Verify or expand the search:
- PubMed search for NCT05851794
- 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 NCT05851794 (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: 6 July 2023
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/NCT05851794.
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