Drainless Robot-assisted Minimally Invasive Esophagectomy (RESPECT)

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.

Study Overview

• Status: Terminated
• Conditions: Esophageal Cancer
• Intervention / Treatment: Procedure: Early removal of chest drain; Procedure: Chest drain

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A - Early removal of chest drain	Procedure: Early removal of chest drain; Chest drains are removed 3 hours after the end of surgery in absence of contraindications in arm A.
Other: B - Control	Procedure: Chest drain; The chest drains in arm B are removed during the further postoperative course according to standard algorithm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	Postoperative pain according to a numeric rating scale	Day 2 after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean postoperative pain	Postoperative pain according to a numeric rating scale	Day 4 after surgery
Additional analgesic drug use	opioids [mg], non-opioids [mg]	Day 4 after surgery
Postoperative mobilization	steps per day as measured with an activity tracker	Day 7 after surgery
Postoperative morbidity	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	Through hospital stay, an average of 14 days
Postoperative mortality	The postoperative mortality of all patients is assessed between operation date and date of death of any cause during hospital stay	Through hospital stay, an average of 14 days
Daily postoperative pain	Postoperative pain according to a numeric rating scale measured daily from postoperative day 1-7	Day 7 after surgery

Collaborators and Investigators

• Sponsor: Technische Universität Dresden
• Collaborators: German Cancer Research Center
• Investigators: Principal Investigator: Johanna Kirchberg, Dr. med., Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2023
• Primary Completion (Actual): May 21, 2024
• Study Completion (Actual): May 21, 2024

Study Registration Dates

• First Submitted: August 19, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): June 13, 2024
• Last Update Submitted That Met QC Criteria: June 12, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Enhanced Recovery after Surgery (ERAS); Esophagectomy; Robot-assisted minimally invasive esophagectomy (RAMIE)
• Other Study ID Numbers: VTG-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No