Influence of Wrap Fixation Technique on… | Clinical Trial

Key information

Conditions

Gastro Oesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

Recurrence rate of hiatal hernia

Time frame: 60 months

Recurrence of hiatal hernia will be assessed by barium contrast swallow study
Slipped wrap

Time frame: 60 months

Slipped wrap will be assessed by barium contrast swallow study

Secondary outcomes

Quality of life and satisfaction

Time frame: 60 months

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.

Sponsors and collaborators

Lead sponsor

Grubnik Volodymyr

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2019
First posted: Apr 6, 2020
Registry last updated: Apr 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed