Approach to Hiatal Hernia Repair Based on Collagen Study

Groups of patients who underwent laparoscopic repair of large hiatal hernias by primary posterior crural repair and crural repair with ProGrip™ mesh techniques were examined for recurrence rate of hiatal hernias, quality of life according to the GERD-HRQL questionnaire. Clinical evaluation was performed at 3, 6, 12, 24, 36, and 48 months after surgery.

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Key information

Conditions

Hiatal Hernia Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastroesophageal Reflux Disease Gastrointestinal Diseases Hernia Hernia, Diaphragmatic Hernia, Hiatal Internal Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The laparoscopic repair of large hiatal hernias is mostly performed by cruroraphy or cruroraphy with mesh reinforcement techniques.

Cruroraphy it is suturing of the right and left diaphragmatic crura using nonabsorbable stitches. Main disadvantage of such technique is the high hiatal hernia recurrence rate after surgery.

Cruroraphy with mesh reinforcement technique followed by relatively less hiatal hernia recurrence rate but associated with a large number of mesh-related complications.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Age older than 20 years
Initially suffering from large hiatal hernia (>20% of the stomach in the thoracic cavity)
Performance of laparoscopic hiatal hernia repair
Informed Consent as documented by signature

Exclusion criteria

Cases of conversion to open surgery
Age < 20 years and > 80 years
History of oesophageal/gastric/duodenal surgery including vagotomy

Treatment and study plan

Laparoscopic hiatal hernia repair with ProGrip™ mesh

Procedure

Suturing of the right and left diaphragmatic crura using 3 to 4 interrupted nonabsorbable stitches with additional reinforcement of crura repair with ProGrip™ mesh

Other names: Laparoscopic mesh hiatoplasty, Laparoscopic mesh hiatal closure

Laparoscopic primary posterior crural repair

Procedure

Posterior cruroraphy will be performed with 3 to 4 interrupted non-absorbable sutures

Other names: Laparoscopic posterior crurorrhaphy, Laparoscopic posterior crural closure

Primary outcomes

Recurrence rate of hiatal hernia

Time frame: 36 months

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

Secondary outcomes

Quality of life and satisfaction

Time frame: 36 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: 2014
Primary completion: 2019
Study completion: 2019
First posted: Nov 5, 2019
Registry last updated: Nov 7, 2019

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.

Published trials that share one or more normalized conditions with this study.

Completed