Drainless Robot-assisted Minimally Invasive Esophagectomy (RESPECT)

• ClinicalTrials.gov Identifier: NCT05553795
• Recruitment Status: Recruiting
• First Posted: September 23, 2022
• Last Update Posted: April 28, 2023
• Sponsor: Technische Universität Dresden
• Collaborator: German Cancer Research Center
• Information provided by (Responsible Party): Technische Universität Dresden

Tracking Information

• First Submitted Date: August 19, 2022
• First Posted Date: September 23, 2022
• Last Update Posted Date: April 28, 2023
• Actual Study Start Date: April 19, 2023
• Estimated Primary Completion Date: October 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 22, 2022)

Postoperative pain [ Time Frame: Day 2 after surgery ]

Postoperative pain according to a numeric rating scale

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 22, 2022)

• Mean postoperative pain [ Time Frame: Day 4 after surgery ]
  Postoperative pain according to a numeric rating scale
• Additional analgesic drug use [ Time Frame: Day 4 after surgery ]
  opioids [mg], non-opioids [mg]
• Postoperative mobilization [ Time Frame: Day 7 after surgery ]
  steps per day as measured with an activity tracker
• Postoperative morbidity [ Time Frame: 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 [ Time Frame: 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
• Daily postoperative pain [ Time Frame: Day 7 after surgery ]
  Postoperative pain according to a numeric rating scale measured daily from postoperative day 1-7

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Drainless Robot-assisted Minimally Invasive Esophagectomy
• Official Title: Drainless Robot-assisted Minimally Invasive Esophagectomy
• 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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized controlled multicentric trial

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Esophageal Cancer

Intervention

• Procedure: Early removal of chest drain
  Chest drains are removed 3 hours after the end of surgery in absence of contraindications in arm A.
• Procedure: Chest drain
  The chest drains in arm B are removed during the further postoperative course according to standard algorithm.

Study Arms

• Experimental: A - Early removal of chest drain
  Intervention: Procedure: Early removal of chest drain
• B - Control
  Intervention: Procedure: Chest drain

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 22, 2022): 72
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2024
• Estimated Primary Completion Date: October 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Korn, Dr. rer. nat.; +493514584098; studienzentrum-vtg@uniklinikum-dresden.de

• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT05553795
• Other Study ID Numbers: VTG-11
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Technische Universität Dresden
• Original Responsible Party: Same as current
• Current Study Sponsor: Technische Universität Dresden
• Original Study Sponsor: Same as current
• Collaborators: German Cancer Research Center

Investigators

• Principal Investigator: Johanna Kirchberg, Dr. med.; Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus

• PRS Account: Technische Universität Dresden
• Verification Date: April 2023