Comparison of Drainage Methods in Minimally Invasive Esophagectomy

Not Applicable

Recruiting

• Conditions: Esophageal Cancer; Drainage/Methods; Postoperative Pain

• Registration Number: NCT07004634
• Lead Sponsor: Ruijin Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-04-30
• Study First Submitted: 2025-05-05
• Study First Submitted QC: 2025-05-26
• Last Update Submitted: 2025-05-26
• Study First Posted: 2025-06-04
• Last Update Posted: 2025-06-04
• Primary Completion: 2026-05-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China