Summary of procedure related events reported during the study
Event no. | Group | Nature | Category | Description | Frequency | Length of hospital stay (d) | Severity |
1 | EFTP | AE | Pain | Left sided chest pain | 1/35 (2.8%) | 3 | Mild |
2 | EFTP | Incident | Left shoulder pain | 8/35 (22.8%) | 1 | – | |
3 | EFTP | AE | Pulmonary | Fever, moderate left sided pleural effusion | 1/35 (2.8%) | 5 | Moderate |
4 | EFTP | Incident | Bleeding | Intraoperative bleeding at the site of suture application | 5/35 (14.2%) | 1 | – |
AE, adverse event; EFTP, endoscopic full-thickness plication.