Pilot Study for High Output Drainage Removal After Gastrectomy

NCT06690112 | Recruiting

• 1 other identifier: 3-2023-0393
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Drainage tube; Gastrectomy; High output

Outcome Measures

Primary Outcomes (1)

• Incidence of Intra-Abdominal Complications

  Complications include infections, abscesses, or any clinically significant intra-abdominal issues that require medical intervention.

  up to 1 month

Secondary Outcomes (2)

• Drain-Related Complications

  up to 1month

• CRP Level Changes

  up to 1month

Study Arms (2)

Drainage removal group

EXPERIMENTAL

Patients who remove their draiange tube at discharge

Procedure: Arm I (Drainage tube removal)

Drainage maintain group

NO INTERVENTION

Patients who maintain their draiange tube at discharge

Interventions

Arm I (Drainage tube removal) 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 removal group

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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:
• 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:
• i. White blood cell count (WBC) \> 15,000/μL ii. C-reactive protein \> 200 mg/L
• Observation of non-serous drainage fluid, such as:

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

Gangnam Severacne Hospital Yonsei University College of Medicine

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

In-Kyu Kwon

CONTACT

82-2-2019-4601; gsirb@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Open label Randomized controlled study

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: November 15, 2024
• Study Start: January 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: July 31, 2025
• Last Updated: January 8, 2025

Record last verified: 2025-01

Locations

KR (1)