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Drainless Robot-assisted Minimally Invasive Esophagectomy (RESPECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05553795
Recruitment Status : Recruiting
First Posted : September 23, 2022
Last Update Posted : April 28, 2023
Sponsor:
Collaborator:
German Cancer Research Center
Information provided by (Responsible Party):
Technische Universität Dresden

Study Description
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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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Procedure: Early removal of chest drain Procedure: Chest drain Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled multicentric trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Drainless Robot-assisted Minimally Invasive Esophagectomy
Actual Study Start Date : April 19, 2023
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : December 2024

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Arms and Interventions
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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.
B - Control Procedure: Chest drain
The chest drains in arm B are removed during the further postoperative course according to standard algorithm.


Outcome Measures
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Primary Outcome Measures :
  1. Postoperative pain [ Time Frame: Day 2 after surgery ]
    Postoperative pain according to a numeric rating scale


Secondary Outcome Measures :
  1. Mean postoperative pain [ Time Frame: Day 4 after surgery ]
    Postoperative pain according to a numeric rating scale

  2. Additional analgesic drug use [ Time Frame: Day 4 after surgery ]
    opioids [mg], non-opioids [mg]

  3. Postoperative mobilization [ Time Frame: Day 7 after surgery ]
    steps per day as measured with an activity tracker

  4. 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

  5. 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

  6. Daily postoperative pain [ Time Frame: Day 7 after surgery ]
    Postoperative pain according to a numeric rating scale measured daily from postoperative day 1-7


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05553795


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

Locations
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Germany
Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden Recruiting
Dresden, Saxony, Germany, 01307
Contact: Johanna Kirchberg, Dr. med.         
Sponsors and Collaborators
Technische Universität Dresden
German Cancer Research Center
Investigators
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Principal Investigator: Johanna Kirchberg, Dr. med. Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus
More Information
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Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT05553795    
Other Study ID Numbers: VTG-11
First Posted: September 23, 2022    Key Record Dates
Last Update Posted: April 28, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Technische Universität Dresden:
Esophagectomy
Enhanced Recovery after Surgery (ERAS)
Robot-assisted minimally invasive esophagectomy (RAMIE)