NCT06690112

Pilot Study for High Output Drainage Removal After Gastrectomy

A Pilot Study Comparing the Incidence of Intra-abdominal Complications According to the Removal of the Drainage Tube in Patients With Large Amounts of Drainage After Gastrectomy in Gastric Cancer Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Gangnam Severance Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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 4th day after surgery. Patients with stage IV cancer, peritoneal metastasis, or postoperative complications requiring additional intervention are excluded. \*Methods: All participants will follow standard postoperative care except for the removal or retention of the drainage tube. Follow-up will occur at 1 and 3 weeks post-discharge, with clinical examinations and imaging (if necessary) to monitor for complications such as infection or abscess. The study's total observation period will last four weeks from the surgery date. \*Data Collection: Data will include patient demographics, surgical details, postoperative management, and the occurrence of complications. Drainage volumes will be recorded daily for those discharged with a tube, and tube removal will occur based on specific criteria.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
PROCEDURE	Arm I (Drainage tube removal)	During gastrectomy, a drainage tube is placed within the abdominal cavity. In Arm I (the intervention group), the drainage tube will be removed at the bedside. This procedure is a simple intervention that does not require local anesthesia and involves the removal of the drainage tube by cutting the nylon suture.

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-06-30
• Completion: 2025-07-31
• First posted: 2024-11-15
• Last updated: 2025-01-08

Locations

1 site across 1 country: South Korea