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Influence of Wrap Fixation Technique on the Results of Fundoplication | Clinical Trials | Clareo Health

COMPLETEDNA

Influence of Wrap Fixation Technique on the Results of Fundoplication

NCT04335734•Grubnik Volodymyr

Summary

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.

Eligibility

Age

20 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age: 20 - 80 years;
•Gastroesophageal reflux disease as evidence by gastroscopy and pH-monitoring;
•HH type I, II

Exclusion Criteria

•Age \< 20 years and \> 80 years;
•Unable to undergo laparoscopic fundoplication due to: severe comorbidities (ASA III and more), previous major surgery with severe adhesions, etc.;
•HH type III, IV;
•BMI \< 16 and \> 45 kg/m²;
•Pregnancy (in females);
•Oesophageal motility disorders;
•Oesophageal peptic strictures;
•Oesophageal diverticula, other types (i.e. non-reflux) of chronic esophagitis, connective tissue disorders (e.g. scleroderma);
•History of oesophageal/gastric/duodenal surgery including vagotomy;
•Relapsing course of ulcer disease/hyperacid gastritis including complicated by delayed gastric/duodenal emptying

Key Dates

Start Date

November 1, 2012

Primary Completion Date

October 1, 2014

Completion Date

May 28, 2019

Last Updated

April 6, 2020

Enrollment

138

ACTUAL participants

Conditions

Gastro Oesophageal Reflux Disease

Interventions

Nissen Fundoplication with wrap fixation

PROCEDURE

Nissen Fundoplication without wrap fixation

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 6, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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