Comparison of Drainage Methods in Minimally Invasive Esophagectomy (DEMURE）
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Pathologically confirmed esophageal cancer requiring three-incision esophagectomy (cervical, thoracic, and abdominal incisions)
ASA physical status class I-III
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Chest mediastinal tube
Procedure/SurgeryTransthoracic mediastinal drainage was performed for postoperative management of the patient.
Abdominal mediastinal tube
Procedure/SurgeryTransperitoneal mediastinal drainage was performed for postoperative management of the patient.
Chest tube + chest mediastinal tube
Procedure/SurgeryChest tube insertion combined with transthoracic mediastinal drainage was performed for postoperative management of the patient.
Treatment groups
75 Participants
are divided into 3 treatment groupsGroup A: Abdominal mediastinal tubeExperimental treatment 1 intervention
Group B: Chest mediastinal tubeExperimental treatment 1 intervention
Group C: Chest tube + chest mediastinal tubeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Postoperative Pain Scores
Pain scores were assessed based on the visual analog scale according to the World Health Organization guidelines, in which 0 indicated no pain and 10 indicated the worst possible pain. We also recorded and evaluated maximum daily pain scores when pain caused by the mediastinal drainage tube incision.
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 outcomes
1
Postoperative complications
Postoperative complications included anastomotic leak, major pulmonary complications, and major abdominal complications. Pleural effusion was defined as a drainage volume of greater than 800 mL. Pneumothorax was defined by a distance of greater than 3 cm between the apex of the lung and the top of the ribcage on chest radiography.
Time frame
Postoperative complications from posoperative day 1 to postoperative month 3Sponsors and contacts
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Source ClinicalTrials.gov