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

Paracelsus Medical University (PMU)

Status: Not yet enrolling

Conditions: Hiatal Hernia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04591860

Phasix™ST - Austria

Details and patient eligibility

About

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.

Enrollment: 165 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

165 participants in 3 patient groups

Sutures only

Active Comparator group

Description:

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.

Treatment:

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

Absorbable Mesh

Active Comparator group

Description:

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.

Treatment:

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

Pledgeted sutures

Active Comparator group

Description:

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.

Treatment:

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