Approach to Hiatal Hernia Repair Based on Collagen Study

November 5, 2019 updated by: Grubnik Volodymyr
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ProGrip™ mesh repair
Laparoscopic hiatal hernia repair with ProGrip™ mesh
Procedure: Laparoscopic hiatal hernia repair with ProGrip™ mesh
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
Active Comparator: Primary crural repair
Primary posterior crura repair
Procedure: Laparoscopic primary posterior crural repair
Posterior cruroraphy will be performed with 3 to 4 interrupted non-absorbable sutures
Other Names:
  • Laparoscopic posterior crurorrhaphy
  • Laparoscopic posterior crural closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence rate of hiatal hernia
Time Frame: 36 months
Recurrence of hiatal hernia will be assessed by barium contrast swallow study
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grubnik Volodymyr

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

September 20, 2019

Study Completion (Actual)

September 20, 2019

Study Registration Dates

First Submitted

October 26, 2019

First Submitted That Met QC Criteria

November 4, 2019

First Posted (Actual)

November 5, 2019

Study Record Updates

Last Update Posted (Actual)

November 7, 2019

Last Update Submitted That Met QC Criteria

November 5, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONMedU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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