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NCT04335734
Influence of Wrap Fixation Technique on the Results of Fundoplication
NA trial testing Nissen Fundoplication with wrap fixation in Gastro Oesophageal Reflux Disease in 138 participants. Completed in 28 May 2019.
1 October 2014
Quick facts
| Lead sponsor | Grubnik Volodymyr |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 138 |
| Start date | 1 November 2012 |
| Primary completion | 1 October 2014 |
| Estimated completion | 28 May 2019 |
Drugs / interventions tested
- Nissen Fundoplication with wrap fixation
- Nissen Fundoplication without wrap fixation
Conditions studied
- Gastro Oesophageal Reflux Disease — all drugs for Gastro Oesophageal Reflux Disease →
Sponsor
Grubnik Volodymyr
Who can join
Adults 20 to 80, any sex, with Gastro Oesophageal Reflux Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Patients who underwent anti-reflux surgery were divided into two groups. In the I group Nissen fundoplication was supplemented with suturing wrap to the crura or the body of stomach using two non-absorbable stitches on each side. Control group included patients who underwent classic Nissen fundoplication without wrap fixation. All patients were assessed before and after surgery using validated symptoms and quality of life (GERD-HRQL) questionnaires, 24-h impedance-pH monitoring and barium-swallow.
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 NCT04335734
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Grubnik Volodymyr trials
Trials by the same sponsor.
- NCT04152798 — Approach to Hiatal Hernia Repair Based on Collagen Study · NA · completed
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 NCT04335734 (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 Grubnik Volodymyr
- Last refreshed: 6 April 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/NCT04335734.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing