The Value of Lateral Release in Reconstruction of the Diaphragmatic Hiatus Hernia

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-16

Study Completion Date

2026-12-31

Brief Summary

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Patients scheduled for surgery for primary paraesophageal herniation are randomized to either conventional suturing of the crura or with the addition of lateral release.

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Detailed Description

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Patient undergoing surgery for primary paraesophageal herniation, are randomized to either conventional suturing of the diaphragmatic crura only or with the addition of a diaphragmatic incision "lateral release".

The patients are examined by computed tomography before surgery and at 1 and 3 years after surgery.

SF-36 (global quality of Life instrument), GSRS (Gastrointestinal Symptoms Rating Scale), Reflux frequency issues and Watson's dysphagia score are completed before and at 3 and 6 month as well as 1 and 3 years after surgery.

Patients undergoing laparoscopic repair for paraesophageal hernia Type II-IV are eligible for inclusion in the study. Included patients will be randomized to either reconstruction of the hiatus by suturing of the crura alone or in combination with an approximately 4 cm incision of the anterior aspect of the left diaphragma "lateral release" before crural suturing. The incision will be covered with a synthetic patch after crural closure is finished. All other aspects of the surgical procedure are similar in the two groups including complete mobilization of the hernia sac before and a total fundoplication after hiatal restoration, respectively.

Conditions

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Paraesophageal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Crura plastic or crura plastic with the addition of "lateral release"

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

The randomization process is initiated after general anesthesia is induced and the group affiliation will be determined by opening of a sealed envelope specifying the group assignment. The information of group allocation is stored in a closed envelope kept in a locked archive until the study is completed.

Study Groups

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Crura

Closure of the diaphragmatic hiatus by a running suture alone

Group Type ACTIVE_COMPARATOR

Crura plastic

Intervention Type PROCEDURE

Closure of hiatus with a running suture

Crura and lateral release

Closure of the diaphragmatic hiatus by a running suture and an incision of 4 cm of the left diaphragm (lateral release)

Group Type ACTIVE_COMPARATOR

Crura plastic

Intervention Type PROCEDURE

Closure of hiatus with a running suture

Interventions

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Crura plastic

Closure of hiatus with a running suture

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* all patients with primary hiatus hernia type II-IV who are deemed suitable for surgery

Exclusion Criteria

* inability to understand the nature of the purpose of the study and/or to give informed consent.
* American Society of Anesthesiologists physical status-system (ASA) \>III
* Achalasia or another severe esophageal motor disorder

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No