Influence of Wrap Fixation Technique on the Results of Fundoplication

Gastro Oesophageal Reflux Disease Clinical Trial

Official title:

Influence of Wrap Fixation Technique on the Results of Fundoplication

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04335734
• Other study ID #: ONMedU 1
• Status: Completed
• Phase: N/A
• Start date: November 1, 2012
• Est. completion date: May 28, 2019

Study information

• Verified date: April 2020
• Source: Odessa National Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: May 28, 2019
• Est. primary completion date: October 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastro Oesophageal Reflux Disease
• Gastroesophageal Reflux

Intervention

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 ?m² 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 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 ?m² 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Grubnik Volodymyr

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rate of hiatal hernia	Recurrence of hiatal hernia will be assessed by barium contrast swallow study	60 months
Primary	Slipped wrap	Slipped wrap will be assessed by barium contrast swallow study	60 months
Secondary	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