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NCT05851794

Intraoperative Endomanometric Laparoscopic Nissen Fundoplication Improves Postoperative Outcomes

Completed NA Last updated 6 July 2023
What this trial tests

NA trial testing endomanometric guided LNF in GERD in 360 participants. Completed in 1 April 2023.

Timeline
1 April 2012
Primary endpoint
1 April 2020
1 April 2023

Quick facts

Lead sponsorZagazig University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment360
Start date1 April 2012
Primary completion1 April 2020
Estimated completion1 April 2023

Drugs / interventions tested

Conditions studied

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):

  1. 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

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Other recruiting trials for GERD

Currently open trials in the same condition.

Other Zagazig University trials

Trials by the same sponsor.

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Data sources for this page

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