Sutures Only Versus Absorbable Polyglactin (Vicryl4) Mesh in Closure of Hiatal Defect in Laparoscopic Paraesophageal Hernia Repair: Randomized Controlled Trial

What this Trial Is About

This research investigates treatments for paraesophageal hernia, a condition causing pain, heartburn, regurgitation, anemia, and in severe cases, dangerous strangulation. The study compares traditional laparoscopic surgery using sutures alone to surgery reinforced with absorbable polyglactin mesh. The goal is to find if mesh use reduces the high hernia recurrence rates observed with sutures alone. This trial is a randomized controlled study aiming to enroll 110 patients with symptomatic paraesophageal hernia confirmed by imaging or endoscopy. Participants will be randomly assigned to one of two groups: one receiving traditional suture closure of the hiatal defect, and the other receiving suture closure reinforced with polyglactin mesh applied in a keyhole fashion. The mesh used is absorbable, degrading in 6 to 8 weeks. The primary focus is on hernia recurrence six months after surgery, with follow-up extending up to 20 years to assess reoperations, quality of life, and use of proton pump inhibitors. During the study, participants will undergo computed tomography scans six months after surgery to detect hernia recurrence. Researchers will also monitor symptoms, reoperation rates, quality of life via questionnaires, and medication use over a long term. Data on factors like hiatal defect size, body mass index, age, and albumin levels will be collected to understand their relationship with recurrence risk. The total study duration accommodates extended observation for up to two decades post-surgery.

Sutures Versus Polyglactin Mesh in Hiatal Hernia Repair