Pilot Study for High Output Drainage Removal After Gastrectomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-79
SponsorGangnam Severance Hospital

About this trial

\*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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Arm I (Drainage tube removal)

    Procedure/Surgery

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Drainage removal groupExperimental treatment 1 intervention
Group B: Drainage maintain groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Incidence of Intra-Abdominal Complications

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

Time frame
up to 1 month

Secondary outcomes

1

Drain-Related Complications

The occurrence of complications related to the drainage tube in the control group, such as infection at the insertion site or mechanical issues.

Time frame
up to 1month
2

CRP Level Changes

The comparison of C-reactive protein (CRP) level changes between the intervention and control groups during the 4-week postoperative follow-up. CRP levels will be measured to assess inflammation and potential early signs of complications.

Time frame
up to 1month

Other outcomes

Sponsors and contacts

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