A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias: Absorbable Mesh vs. Pledgeted Sutures vs. Sutures Only

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2027-05-01

Brief Summary

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A prospective randomised multi - center trial on the repair of large hiatal hernias with sutures versus pledgeted sutures versus absorbable mesh

The primary objective of the present trial is to compare the hiatal hernia recurrence rate between three different methods of cruroplasty in large hiatal hernias: hiatal closure with sutures versus pledgeted sutures versus absorbable mesh (Phasix™ST mesh).

The duration of the study is not limited and depends on the number of cases planned. After enrollment in the study, patients will be followed - up with standardized questionnaires and gastroscopy at 6 months, 1 year, 3 years and 5 years after surgery.

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Detailed Description

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Conditions

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Hiatal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

The primary objective of the present trial is to compare the hiatal hernia recurrence rate between three different methods of cruroplasty in large hiatal hernias: hiatal closure with sutures versus pledgeted sutures versus absorbable mesh (Phasix™ST mesh).

The study includes patients who are scheduled to undergo laparoscopic or robot-assisted surgery for a large symptomatic hiatal hernia. A large hiatal hernia is defined as \> 5cm in manometry or gastroscopy or at least 1/3 of the stomach lying intrathoracically. The primary study endpoint is defined as the hernia recurrence rate, objectively assessed by gastroscopy. After inclusion in the study, patients will be followed up 6 months, 1 year, 3 years and 5 years after the operation using standardized questionnaires and gastroscopy.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sutures only

Patients with a large hiatal hernia undergo the cruroplasty with sutures only.

A large hiatal hernia is defined as \> 5cm in manometry or gastroscopy or at least 1/3 of the stomach lying intrathoracically.

Group Type ACTIVE_COMPARATOR

Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet

Intervention Type DEVICE

Patients are scheduled to undergo laparoscopic or robot-assisted surgery for a large symptomatic hiatal hernia.The hiatal closure will be done with sutures, pledgeted sutures or absorbable mesh (Phasix™ST mesh). After cruroplasty a fundoplication according to Toupet will be done additionally.

Absorbable Mesh

Patients with a large hiatal hernia undergo the cruroplasty with mesh implantation.

A large hiatal hernia is defined as \> 5cm in manometry or gastroscopy or at least 1/3 of the stomach lying intrathoracically.

Group Type ACTIVE_COMPARATOR

Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet

Intervention Type DEVICE

Patients are scheduled to undergo laparoscopic or robot-assisted surgery for a large symptomatic hiatal hernia.The hiatal closure will be done with sutures, pledgeted sutures or absorbable mesh (Phasix™ST mesh). After cruroplasty a fundoplication according to Toupet will be done additionally.

Pledgeted sutures

Patients with a large hiatal hernia undergo the cruroplasty with pledgeted sutures.

A large hiatal hernia is defined as \> 5cm in manometry or gastroscopy or at least 1/3 of the stomach lying intrathoracically.

Group Type ACTIVE_COMPARATOR

Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet

Intervention Type DEVICE

Patients are scheduled to undergo laparoscopic or robot-assisted surgery for a large symptomatic hiatal hernia.The hiatal closure will be done with sutures, pledgeted sutures or absorbable mesh (Phasix™ST mesh). After cruroplasty a fundoplication according to Toupet will be done additionally.

Interventions

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Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet

Patients are scheduled to undergo laparoscopic or robot-assisted surgery for a large symptomatic hiatal hernia.The hiatal closure will be done with sutures, pledgeted sutures or absorbable mesh (Phasix™ST mesh). After cruroplasty a fundoplication according to Toupet will be done additionally.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with a large hiatal hernia - admitted for surgery (laparoscopic / robot-assisted)
* Written informed consent
* ≥ 18 years of age
* Hiatal hernia documented by barium x-ray and/or gastroscopy and/or manometry by one or more of the following criteria:

* \> 5cm hiatal hernia
* 1/3 of the stomach in the thorax

Exclusion Criteria

* Lack of patient consent for study participation
* Lack of consent to study due to linguistic or mental incomprehension
* Patients in poor general condition (lack of anesthesia ability)
* Pregnancy
* Prior surgery on the stomach or gastroesophageal junction
* Simultaneous surgery because of another illness

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No