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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abdominal mediastinal tube | Experimental | Transperitoneal mediastinal drainage was performed for postoperative management of the patient. |
|
| Chest mediastinal tube | Experimental | Transthoracic mediastinal drainage was performed for postoperative management of the patient. |
|
| Chest tube + chest mediastinal tube | Experimental | Chest tube insertion combined with transthoracic mediastinal drainage was performed for postoperative management of the patient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chest mediastinal tube | Procedure | Transthoracic mediastinal drainage was performed for postoperative management of the patient. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Postoperative complications from posoperative day 1 to postoperative month 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hecheng Li, PhD, MD | Contact | 00862164370045 | 664566 | lihecheng2000@hotmail.com |
| Wangyang Meng, MD | Contact | 00861592767592 | mengwymed@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hecheng Li, PhD, MD | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
De-identified baseline characteristics, outcomes, and adverse events.
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015505 | Chest Tubes |
| ID | Term |
|---|---|
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Abdominal mediastinal tube | Procedure | Transperitoneal mediastinal drainage was performed for postoperative management of the patient. |
|
| Chest tube + chest mediastinal tube | Procedure | Chest tube insertion combined with transthoracic mediastinal drainage was performed for postoperative management of the patient. |
|
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |