Drainless Robot-assisted Minimally Invasive Esophagectomy

Not Applicable

Terminated

• Conditions: Esophageal Cancer
• Interventions: Procedure: Early removal of chest drain; Procedure: Chest drain

• Registration Number: NCT05553795
• Lead Sponsor: Technische Universität Dresden

Brief Summary

The aim of this study is the evaluation of two different chest drain management strategies in patients undergoing robot-assisted minimally invasive esophagectomy (RAMIE) for esophageal cancer with regard to perioperative complications until discharge.The primary objective of the study is to investigate whether the intensity of postoperative pain can be significantly reduced by avoiding thoracic drains after RAMIE. We assume that this will influence secondary endpoints such as early recovery and length of hospital stay.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-19
• Study First Submitted QC: 2022-09-22
• Study First Posted: 2022-09-23
• Study Start: 2023-04-19
• Primary Completion: 2024-05-21
• Study Completion: 2024-05-21
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• Patients scheduled for elective RAMIE for esophageal cancer with intrathoracic esophagogastrostomy (Ivor-Lewis)
• American Society of Anesthesiologists (ASA) score ≤ III
• Eastern Cooperative of Oncology Group (ECOG) status ≤ II
• Patient suitable for both surgical techniques
• Ability of subject to understand character and individual consequences of the clinical trial
• Written informed consent

Exclusion Criteria

• Open esophagectomy (either abdominal or during the thoracic part)
• Emergency operations
• ASA IV
• ECOG > II
• Chronic pain syndromes requiring routine analgesics
• Simultaneous lung resection
• Presence of contraindications to the use of epidural anesthesia (e.g. coagulopathies, anticoagulation or allergies)
• Participation in an interventional trial, which interferes with the outcome
• Impaired mental state

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A - Early removal of chest drain	Early removal of chest drain	-
B - Control	Chest drain	-

Primary Outcome Measures

Name	Time	Method
Postoperative pain	Day 2 after surgery	Postoperative pain according to a numeric rating scale

Secondary Outcome Measures

Name	Time	Method
Postoperative morbidity	Through hospital stay, an average of 14 days	The postoperative morbidity of all patients is assessed with the comprehensive complication index based on Clavien Dindo classification from postoperative day 1 until day of discharge
Postoperative mortality	Through hospital stay, an average of 14 days	The postoperative mortality of all patients is assessed between operation date and date of death of any cause during hospital stay
Mean postoperative pain	Day 4 after surgery	Postoperative pain according to a numeric rating scale
Additional analgesic drug use	Day 4 after surgery	opioids \[mg\], non-opioids \[mg\]
Postoperative mobilization	Day 7 after surgery	steps per day as measured with an activity tracker
Daily postoperative pain	Day 7 after surgery	Postoperative pain according to a numeric rating scale measured daily from postoperative day 1-7

Trial Locations

Locations (1)

Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden; 🇩🇪 Dresden, Saxony, Germany