Influence of Wrap Fixation Technique on the Results of Fundoplication

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.

Study Overview

• Status: Completed
• Conditions: Gastro Oesophageal Reflux Disease
• Intervention / Treatment: Procedure: Nissen Fundoplication with wrap fixation; Procedure: Nissen Fundoplication without wrap fixation

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nissen fundoplication with fixation of the wrap; In this arm, which included 87 patients we performed the following manipulations: NF was supplemented with suturing wrap to the diaphragmatic crura (52 patients) on each side using two non-absorbable stitches. In case of weak conditions of crura or short esophagus (35 patients) fundoplication wrap was sutured to the body of stomach using two non-absorbable stitches on each side. .	Procedure: Nissen Fundoplication with wrap fixation; Firstly, we performed left crural dissection, division of the short gastric vessels, right crural dissection, and esophageal mobilization. Then repair of HH were made by simple cruroraphy if the size of the defect was less then 10 сm² otherwise mesh for reinforcement of cruroraphy was used. Creation of the wrap was made by passing posterior fundus behind the esophagus from left to right, followed by stitching the edges of the stomach with three interrupted sutures. Wrap was fixated to both diaphragmatic crura or to the body of stomach using two non-absorbable stitches on each side.
Active Comparator: Nissen fundoplication without fixation of the wrap; Arm included 51 patients, who underwent classic Nissen fundoplication without wrap fixation.	Procedure: Nissen Fundoplication without wrap fixation; Firstly, we performed left crural dissection, division of the short gastric vessels, right crural dissection, and esophageal mobilization. Then repair of HH were made by simple cruroraphy if the size of the defect was less then 10 сm² otherwise mesh for reinforcement of cruroraphy was used. Creation of the wrap was made by passing posterior fundus behind the esophagus from left to right, followed by stitching the edges of the stomach with three interrupted sutures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence rate of hiatal hernia	Recurrence of hiatal hernia will be assessed by barium contrast swallow study	60 months
Slipped wrap	Slipped wrap will be assessed by barium contrast swallow study	60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life and satisfaction	Quality of life and satisfaction will be assessed by Gastroesophageal reflux disease - health-related quality of life (GERD-HRQL) score. The scale has 11 items,each item is scored from 0 to 5. A higher score indicating a better quality of life.	60 months

Collaborators and Investigators

• Sponsor: Grubnik Volodymyr

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2012
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): May 28, 2019

Study Registration Dates

• First Submitted: April 2, 2020
• First Submitted That Met QC Criteria: April 2, 2020
• First Posted (Actual): April 6, 2020

Study Record Updates

• Last Update Posted (Actual): April 6, 2020
• Last Update Submitted That Met QC Criteria: April 2, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Gastro Oesophageal Reflux Disease, Nissen Fundoplication
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux
• Other Study ID Numbers: ONMedU 1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No