Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing

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

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-11

Study Completion Date

2022-05-31

Brief Summary

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One-hundred and fifty-nine patients undergoing Nissen fundoplication for symptomatic gastro-oesophageal reflux disease (GORD), who had a concomitant hiatal hernia of \> 2 cm axial length, were randomized to closure of the diaphragmatic hiatus with either crural sutures alone or tension-free closure with a non-absorbable mesh. Primary outcome variable was the incidence of radiologically verified recurrent hiatal hernia. Secondary outcomes were per-and postoperative complications and courses, symptomatic recurrence rate, use of PPI, postoperative oesophageal acid exposure and Quality of Life.

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Detailed Description

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The basic principles behind successful surgical repair of the anatomy and function of the gastro-oesophageal junction (GOJ) in gastro-oesophageal reflux disease (GORD) is not only to encircle the distal oesophagus and GOJ by the fundic wrap but also to complete a transhiatal reduction of a concomitant hiatal hernia (type I, HH), aiming for a 2 - 3 cm intra-abdominal length of the of oesophagus and to transact a tension-free hiatal closure. The physiological and morphological characteristics of the diaphragmatic hiatus, however, carry a challenge for the selection of the ideal technique for surgical repair. The diaphragmatic hiatus consists of a three-dimensional structure in constant motion, which creates a border between the counteracting pressures prevailing in the abdominal and chest cavities, respectively. Following hernia reduction, the structural quality of the diaphragmatic pillars is usually weak, offering poor support for the subsequent closure with risk for high recurrence rates. These and other considerations have encouraged the exploration of mesh reinforcement to enhance the durability of the hiatal closure.

Conditions

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Hiatal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

repair by tension-free mesh closure or simple suturing of the diaphragmatic

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

The randomization process was initiated after general anesthesia had been induced and the group affiliation was determined by opening of a sealed envelope specifying the group assignment. The subsequent operation report, with information on the specific type of repair performed, was not included in the digital patient-chart. Instead, a hard copy was printed and kept in a sealed envelope, which was filed in a locked archive to maintain the patient, staff and clinical assessors blinded to the study group allocation.

Study Groups

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Tension-free

Hiatal hernia repair by tension-free mesh closure

Group Type ACTIVE_COMPARATOR

Hiatal hernia repair by tension-free mesh closure

Intervention Type PROCEDURE

Suturing

Hiatal hernia repair by simple suturing of the diaphragmatic

Group Type ACTIVE_COMPARATOR

Hiatal hernia repair by simple suturing

Intervention Type PROCEDURE

Interventions

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