Influence of Wrap Fixation Technique on the Results of Fundoplication

NCT04335734 | Completed

• 1 other identifier: ONMedU 1
• Study Type: interventional
• Target: 138
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Gastro Oesophageal Reflux Disease

Keywords

Gastro Oesophageal Reflux Disease, Nissen Fundoplication

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Quality of life and satisfaction

  60 months

Study Arms (2)

Nissen fundoplication with fixation of the wrap

ACTIVE COMPARATOR

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

Nissen fundoplication without fixation of the wrap

ACTIVE COMPARATOR

Arm included 51 patients, who underwent classic Nissen fundoplication without wrap fixation.

Procedure: Nissen Fundoplication without wrap fixation

Interventions

Nissen Fundoplication with wrap fixation PROCEDURE

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.

Nissen fundoplication with fixation of the wrap

Nissen Fundoplication without wrap fixation PROCEDURE

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.

Nissen fundoplication without fixation of the wrap

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Grubnik Volodymyr: lead

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Fundoplication

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Professor

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 6, 2020
• Study Start: November 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: May 28, 2019
• Last Updated: April 6, 2020

Record last verified: 2020-04