NCT06690112Recruiting
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
Source: ClinicalTrials.gov · Last updated 8 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
\*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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 29 Oct 2024
- Start date
- 1 Jan 2024
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Gangnam Severance Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06690112
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 Jan 2024 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with evident intra-abdominal complications following surgery.
- Patients who underwent incomplete gastric resection (R1 or R2 resection).
Other illness
- Patients with stage IV gastric cancer.
- 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.
Lab values
- Patients presenting with any of the following clinical signs or diagnoses:
- Postoperative pancreatic fistula (POPF), defined as drain amylase levels (Drain amylase; D-amy) more than 3 times higher than serum amylase levels (Serum amylase; S-amy).
- Fever exceeding 37.8℃.
- Presence of any of the following clinical markers of inflammation:
- White blood cell count (WBC) \> 15,000/μL ii. C-reactive protein \> 200 mg/L
- Observation of non-serous drainage fluid, such as:
- Chylous fluid: Milky-colored fluid. ii. Bloody or sanguineous fluid: Intra-abdominal fluid suggestive of ongoing hemorrhage.
Age
- Patients aged 80 or older.
Other
- Patients with ascites due to peritoneal metastasis.
- Patients who require the insertion of additional percutaneous drainage due to insufficient drainage.
- Patients with more than 500 ml of drainage in the 24 hours on postoperative day 4.
- Vulnerable subjects will not be enrolled in the study, including minors, pregnant women, neonates, adults with impaired consent capacity, individuals in institutional facilities, students, employees of medical institutions or research centers, pharmaceutical company employees, military personnel, unemployed persons, impoverished individuals, homeless individuals, terminally ill patients, or patients in emergency situations.
Who the study is looking for
- 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.
Age in the registry: 18 years to 79 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gangnam Severacne Hospital Yonsei University College of Medicine Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.