Evaluating drainage tube removal after stomach surgery

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

This study is testing if taking out a drainage tube early after stomach surgery for cancer helps prevent complications compared to keeping it in until discharge.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 79 Years
• Sex: All
• Sponsor: Gangnam Severance Hospital (other)
• Locations: 1 site (Seoul)
• Trial ID: NCT06690112 on ClinicalTrials.gov

What this trial studies

This study aims to determine if removing a drainage tube before discharge affects the rate of intra-abdominal complications in patients who have undergone gastrectomy for gastric cancer. It is an open-label randomized controlled trial involving 60 patients, who will be divided into two groups: one will keep the drainage tube while the other will have it removed. The primary focus is on the incidence of complications within one month post-surgery, specifically for those with high postoperative drainage. Eligible participants must have a diagnosis of gastric adenocarcinoma and meet specific postoperative drainage criteria.

Who should consider this trial

Good fit: Ideal candidates are patients diagnosed with gastric adenocarcinoma who are undergoing curative gastrectomy and have a postoperative drainage output of 300-500 ml/day.

Not a fit: Patients with stage IV gastric cancer, significant postoperative complications, or those requiring additional drainage interventions will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved recovery protocols for patients undergoing gastrectomy, potentially reducing complications and hospital stays.

How similar studies have performed: While similar studies on drainage management post-surgery exist, this specific approach to drainage tube removal in gastrectomy patients is relatively novel.

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.

Where this trial is running

Seoul

• Gangnam Severacne Hospital Yonsei University College of Medicine — Seoul, South Korea (RECRUITING)

Study contacts

• Study coordinator: In-Kyu Kwon

Conditions: Gastric Cancer, Drainage tube, Gastrectomy, High output