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

NCT04591860 | Not Yet Recruiting DMC

• 1 other identifier: Phasix™ST - Austria
• Study Type: interventional
• Target: 165
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hiatal Hernia

Keywords

hiatal hernia; pledgets; mesh; hernia recurrence

Outcome Measures

Primary Outcomes (1)

• Hiatal hernia recurrence rate

  Hiatal hernia recurrence rate documented by gastroscopy

  6 months, 1 year, 3 years and 5 years after surgery

Secondary Outcomes (7)

• Quality of Life evaluated by questionnaire

  Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery

• Symptoms related to Gastroesophageal Reflux Disease (GERD)

  Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery

• Primary extraesophageal GERD symptoms related to Gastroesophageal Reflux Disease (GERD)

  Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery

• Postoperative complications

  6 months, 1 year, 3 years and 5 years after surgery

• Length of hospital stay

  up to 90 days

Study Arms (3)

Sutures only

ACTIVE COMPARATOR

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.

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

Absorbable Mesh

ACTIVE COMPARATOR

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.

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

Pledgeted sutures

ACTIVE COMPARATOR

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.

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

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• /3 of the stomach in the thorax

You may not qualify if:

• 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

Sponsors & Collaborators

• Paracelsus Medical University: lead
• Medical University Innsbruck: collaborator
• Medical University of Vienna: collaborator
• Krankenhaus Barmherzige Schwestern Linz: collaborator
• Elisabethinen Hospital: collaborator

Related Publications (1)

• Koch O, von Rahden BHA, Wykypiel H, Schoppmann SF, Fugger R, Rosanelli G, Emmanuel K, Weitzendorfer M. [Planning and Design of a Prospective Randomised Multi-Centre Trial on the Repair of Large Hiatal Hernias with Sutures vs. Pledgeted Sutures vs. Absorbable Mesh]. Zentralbl Chir. 2021 Apr;146(2):204-209. doi: 10.1055/a-1369-9694. Epub 2021 Feb 10. German.

  PMID: 33567462 DERIVED

MeSH Terms

Conditions

Hernia, Hiatal

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Michael Weitzendorfer, MD, PhD

CONTACT

+435725551078; m.weitzendorfer@salk.at

Oliver O Koch, MD, FEBS

CONTACT

+435725551091; o.koch@salk.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Michael Weitzendorfer, PhD

Model Details: 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.

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: October 19, 2020
• Study Start: May 1, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share