Drainage/Methods, Esophageal Cancer, Postoperative Pain
Conditions
Keywords
Esophageal cancer, Mediastinal drainage tube, Postoperative pain
Brief summary
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
PROCEDUREChest mediastinal tube
Transthoracic mediastinal drainage was performed for postoperative management of the patient.
PROCEDUREAbdominal mediastinal tube
Transperitoneal mediastinal drainage was performed for postoperative management of the patient.
PROCEDUREChest tube + chest mediastinal tube
Chest tube insertion combined with transthoracic mediastinal drainage was performed for postoperative management of the patient.
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Scores | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications | Postoperative complications from posoperative day 1 to postoperative month 3 | 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. |
Countries
China
Contacts
Primary ContactHecheng Li, PhD, MD
Backup ContactWangyang Meng, MD
Outcome results
None listed