Comparison of Drainage Methods in Minimally Invasive Esophagectomy (DEMURE）

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Postoperative Pain; Esophageal Cancer; Drainage/Methods

Treatments: Procedure: Chest mediastinal tube; Procedure: Chest tube + chest mediastinal tube; Procedure: Abdominal mediastinal tube

Study type: Interventional

Funder types: Other

Identifiers

NCT07004634

RTS-026

Details and patient eligibility

About

This RCT compares three drainage approaches after minimally invasive esophagectomy (chest tube + thoracic mediastinal drainage tube, thoracic, and abdominal mediastinal drainage tube) to evaluate perioperative outcomes, addressing current evidence gaps in pain and complication profiles.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years
• Pathologically confirmed esophageal cancer requiring three-incision esophagectomy (cervical, thoracic, and abdominal incisions)
• ASA physical status class I-III

Exclusion criteria

• History of chronic pain or long-term use of analgesics prior to surgery
• Severe cardiopulmonary dysfunction (e.g., FEV1 <50%)
• Coagulation disorders or patients undergoing reoperation
• Intraoperative findings of extensive pleural adhesions, combined resection of adjacent organs, or other conditions deemed by the investigator to warrant exclusion

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

Abdominal mediastinal tube

Experimental group

Description:

Transperitoneal mediastinal drainage was performed for postoperative management of the patient.

Treatment:

Procedure: Abdominal mediastinal tube

Chest mediastinal tube

Experimental group

Description:

Transthoracic mediastinal drainage was performed for postoperative management of the patient.

Treatment:

Procedure: Chest mediastinal tube

Chest tube + chest mediastinal tube

Experimental group

Description:

Chest tube insertion combined with transthoracic mediastinal drainage was performed for postoperative management of the patient.

Treatment:

Procedure: Chest tube + chest mediastinal tube