Pilot Study for High Output Drainage Removal After Gastrectomy
\*Objective: The study aims to evaluate whether there is a difference in intra-abdominal complication rates between patients discharged with or without a drainage tube following gastrectomy with high postoperative drainage (≥300ml/day). \*Study Design: This is an open-label randomized controlled trial (RCT) involving t
| Condition(s) | Gastric Cancer |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | \*Objective: The study aims to evaluate whether there is a difference in intra-abdominal complication rates between patients discharged with or without a drainage tube following gastrectomy with high postoperative drainage (≥300ml/day). \*Study Design: This is an open-label randomized controlled trial (RCT) involving two groups. Patients will be randomly assigned to either maintain the drainage tube (control) or have it removed (experimental) before discharge. The primary endpoint is the incidence of intra-abdominal complications within one month post-surgery. \*Participants: The study targets 60 patients (30 per group) who meet the following criteria: Diagnosed with gastric adenocarcinoma and underwent curative gastrectomy (R0 resection). Postoperative drainage of 300-500 ml/day on the 4t |
| Who can participate | Inclusion Criteria: * Patients pathologically diagnosed with gastric adenocarcinoma before surgery. * Patients eligible for complete surgical resection (R0 resection). * Patients with an ASA (American Society of Anesthesiologists) score of 3 or lower. * Patients with more than 300 ml of drainage in the 24 hours on the postoperative day 4. Exclusion Criteria: * Patients aged 80 or older. * Patients with stage IV gastric cancer. * Patients with ascites due to peritoneal metastasis. * Patients with evident intra-abdominal complications following surgery. * Patients who require the insertion of additional percutaneous drainage due to insufficient drainage. * Patients who underwent incomplete gastric resection (R1 or R2 resection). * Patients diagnosed with cancers other than gastric cancer. * |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Lead sponsor | Gangnam Severance Hospital |
| Locations | Seoul, South Korea |
| Start date | 2024-01-01 |
| NCT ID | NCT06690112 |
| Official listing | https://clinicaltrials.gov/study/NCT06690112 |