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

Not Applicable

Not yet recruiting

• Conditions: Hiatal Hernia
• Interventions: Device: Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet

• Registration Number: NCT04591860
• Lead Sponsor: Paracelsus Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-17
• Study First Submitted QC: 2020-10-12
• Study First Posted: 2020-10-19
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02
• Study Start: 2024-05-01
• Primary Completion: 2027-05-01
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 165

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sutures only	Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet	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.
Pledgeted sutures	Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet	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.
Absorbable Mesh	Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet	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.

Primary Outcome Measures

Name	Time	Method
Hiatal hernia recurrence rate	6 months, 1 year, 3 years and 5 years after surgery	Hiatal hernia recurrence rate documented by gastroscopy

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	6 months, 1 year, 3 years and 5 years after surgery	Short - term and long - term complications after treatment
Symptoms related to Gastroesophageal Reflux Disease (GERD)	Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery	Typical and atypical GERD symptoms assessed by the Symptom Check List (SCL) in units of a scale.
Predictive parameters for treatment response or failure I	Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery	Weight (in kilograms)
Quality of Life evaluated by questionnaire	Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery	Quality of Life measured by Gastrointestinal Quality of Life Index (GIQLI)
Length of hospital stay	up to 90 days	Length of hospital stay and mortality rates
Primary extraesophageal GERD symptoms related to Gastroesophageal Reflux Disease (GERD)	Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery	Primary atypical GERD symptoms assessed by the Reflux Symptom Index (RSI - Score) in units of a scale
Predictive parameters for treatment response or failure II	Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery	Height (in meters)