Approach to Hiatal Hernia Repair Based on Collagen Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-01

Study Completion Date

2019-09-20

Brief Summary

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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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Detailed Description

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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.

Conditions

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Hiatal Hernia Gastroesophageal Reflux Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ProGrip™ mesh repair

Laparoscopic hiatal hernia repair with ProGrip™ mesh

Group Type ACTIVE_COMPARATOR

Laparoscopic hiatal hernia repair with ProGrip™ mesh

Intervention Type 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

Primary crural repair

Primary posterior crura repair

Group Type ACTIVE_COMPARATOR

Laparoscopic primary posterior crural repair

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Laparoscopic primary posterior crural repair

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

Intervention Type PROCEDURE

Other Intervention Names

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Laparoscopic mesh hiatoplasty Laparoscopic mesh hiatal closure Laparoscopic posterior crurorrhaphy Laparoscopic posterior crural closure

Eligibility Criteria

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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