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

Launched by PARACELSUS MEDICAL UNIVERSITY · Oct 12, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at different ways to repair large hiatal hernias, which occur when part of the stomach pushes through the diaphragm into the chest. The study will compare three methods: using regular stitches, special stitches with extra support called pledgeted sutures, and a type of mesh that dissolves over time. The main goal is to see which method leads to the least chance of the hernia coming back after surgery.

To participate in this trial, you need to be at least 18 years old and have a large hiatal hernia that has been confirmed by tests like X-rays or endoscopy. The trial is not yet recruiting participants, but once it starts, those who join will be followed for several years to track their recovery and any issues related to the hernia. This includes completing questionnaires and undergoing check-ups at 6 months, 1 year, 3 years, and 5 years after surgery. It's important to note that some people may not be eligible, such as those who have had previous stomach surgeries or who cannot provide consent for other reasons.

Gender

ALL

Eligibility criteria

• 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