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

A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias With Sutures Versus Pledgeted Sutures Versus Absorbable Mesh

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.

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