Pilot Study for High Output Drainage Removal After Gastrectomy

NCT ID: NCT06690112

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-07-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Drainage removal group

Patients who remove their draiange tube at discharge

Group Type: EXPERIMENTAL

Arm I (Drainage tube removal)

Intervention Type: PROCEDURE

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.

Drainage maintain group

Patients who maintain their draiange tube at discharge

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.
• 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 presenting with any of the following clinical signs or diagnoses:

1. 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).

2. Fever exceeding 37.8℃.

3. Presence of any of the following clinical markers of inflammation:

i. White blood cell count (WBC) > 15,000/μL ii. C-reactive protein > 200 mg/L

4. Observation of non-serous drainage fluid, such as:

i. Chylous fluid: Milky-colored fluid. ii. Bloody or sanguineous fluid: Intra-abdominal fluid suggestive of ongoing hemorrhage.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gangnam Severance Hospital

OTHER

Sponsor Role: lead

Responsible Party

In Gyu Kwon

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gangnam Severacne Hospital Yonsei University College of Medicine

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

In-Kyu Kwon

Role: CONTACT

gsirb@yuhs.ac

82-2-2019-4601

Facility Contacts

In-Kyu kwon

Role: primary

gsirb@yuhs.ac

82-2-2019-4601

Other Identifiers

3-2023-0393

Identifier Type: -

Identifier Source: org_study_id