Actively Recruiting
Pilot Study Comparing Removal Versus Maintenance of Drainage Tube in Gastric Cancer Patients with High Postoperative Drainage After Gastrectomy
Led by Gangnam Severance Hospital · Updated on 2025-01-08
60
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing the rates of intra-abdominal complications in patients who have undergone gastrectomy for gastric adenocarcinoma, focusing on those with high postoperative drainage (300-500 ml/day) on the fourth day after surgery. This open-label randomized controlled trial divides participants into two groups to see if removing or keeping the drainage tube before discharge affects complication rates within one month after surgery. The study aims to include 60 patients who had complete surgical removal of their cancer and meet specific drainage and health criteria. Participants will be randomly assigned to either have their drainage tube removed at the bedside without anesthesia or to keep the tube in place until discharge. All patients will receive standard postoperative care aside from this difference. Follow-up visits are planned at one and three weeks after discharge, where doctors will perform clinical exams and imaging if needed to check for complications like infection or abscess. Drainage volumes will be recorded daily for patients discharged with the tube, and the total observation period lasts four weeks from surgery. During the study, researchers will collect data on patient characteristics, surgical details, and postoperative management. Participants will be monitored closely for any intra-abdominal complications up to one month after surgery. The primary outcome measured is the occurrence of these complications during this time. This careful follow-up ensures the safety and accurate assessment of the effects of drainage tube removal or retention in this patient group.
CONDITIONS
Official Title
Pilot Study for High Output Drainage Removal After Gastrectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
- Patients with a history of major intra-abdominal surgery or abdominal radiotherapy that may hinder the normal absorption of intra-abdominal fluid.
- Patients with more than 500 ml of drainage in the 24 hours on postoperative day 4.
- Patients with postoperative pancreatic fistula (drain amylase more than 3 times serum amylase).
- Patients with fever exceeding 37.86C.
- Patients with white blood cell count over 15,000/bcL or C-reactive protein over 200 mg/L.
- Patients with non-serous drainage fluid such as milky or bloody fluid.
- Vulnerable subjects including minors, pregnant women, neonates, those with impaired consent capacity, institutionalized individuals, students, employees of medical institutions or research centers, pharmaceutical company employees, military personnel, unemployed, impoverished, homeless, terminally ill, or emergency patients.
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Trial Site Locations
Total: 1 location
1
Gangnam Severacne Hospital Yonsei University College of Medicine
Seoul, South Korea
Actively Recruiting
Research Team
I
In-Kyu Kwon
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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