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NCT04335734

Influence of Wrap Fixation Technique on the Results of Fundoplication

Completed NA Last updated 6 April 2020
What this trial tests

NA trial testing Nissen Fundoplication with wrap fixation in Gastro Oesophageal Reflux Disease in 138 participants. Completed in 28 May 2019.

Timeline
1 November 2012
Primary endpoint
1 October 2014
28 May 2019

Quick facts

Lead sponsorGrubnik Volodymyr
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment138
Start date1 November 2012
Primary completion1 October 2014
Estimated completion28 May 2019

Drugs / interventions tested

Conditions studied

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.

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Other Grubnik Volodymyr trials

Trials by the same sponsor.

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Data sources for this page

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