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Recruiting NCT07004634

Comparison of Drainage Methods in Minimally Invasive Esophagectomy (DEMURE）

No phase Interventional Esophageal Cancer Drainage/Methods Postoperative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Chest mediastinal tube, Abdominal mediastinal tube, Chest tube + chest mediastinal tube.
Who it may be relevant to
Registry conditions: Esophageal Cancer, Drainage/Methods, Postoperative Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparison of the Application Effects of Different Drainage Modes in the Perioperative Period of Minimally Invasive Three-Field Radical Esophagectomy for Esophageal Cancer

Overview

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.

Interventions

  • Procedure Chest mediastinal tube
    Transthoracic mediastinal drainage was performed for postoperative management of the patient.
  • Procedure Abdominal mediastinal tube
    Transperitoneal mediastinal drainage was performed for postoperative management of the patient.
  • Procedure Chest tube + chest mediastinal tube
    Chest tube insertion combined with transthoracic mediastinal drainage was performed for postoperative management of the patient.

Primary outcome measures

  • Postoperative Pain Scores [Time frame: Pain scores were recorded at different times during the postoperative period when the patients were quiet and active (at 7 AM, 11 AM, 3 PM, and 7 PM) from postoperative day 1 to postoperative day 4.]
Secondary outcome measures (1)
  • Postoperative complications [Time frame: Postoperative complications from posoperative day 1 to postoperative month 3]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

China · 1 center
  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai

Identifiers

NCT: NCT07004634 · RTS-026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗