Patients seeking laparoscopic paraesophageal hernia repair who meet the study’s criteria will be offered an opportunity to participate (Table 1). Participants will be randomized in 2:1 fashion for treatment with mesh suture or standard suture, respectively. We believe this allocation ratio will reduce the impact of a mesh suture-related ‘learning curve’ without significantly affecting the study’s power. Sample size (n=80) was calculated at 53 patients for the mesh suture group and 27 patients for the standard group, assuming a 10% drop out rate.
|Effective start/end date||7/1/18 → 6/30/21|
- Northwestern Memorial Hospital (AGMT 7/24/18)
- Digestive Health Foundation (AGMT 7/24/18)