Drainless Robot-assisted Minimally Invasive Esophagectomy

Esophageal Cancer Clinical Trial

— RESPECT  

Official title:

Drainless Robot-assisted Minimally Invasive Esophagectomy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05553795
• Other study ID #: VTG-11
• Status: Terminated
• Phase: N/A
• Start date: April 19, 2023
• Est. completion date: May 21, 2024

Study information

• Verified date: June 2024
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 49
• Est. completion date: May 21, 2024
• Est. primary completion date: May 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 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.
• Chest drain
The chest drains in arm B are removed during the further postoperative course according to standard algorithm.

Locations

Country	Name	City	State
Germany	Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden	Dresden	Saxony

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität Dresden	German Cancer Research Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	Postoperative pain according to a numeric rating scale	Day 2 after surgery
Secondary	Mean postoperative pain	Postoperative pain according to a numeric rating scale	Day 4 after surgery
Secondary	Additional analgesic drug use	opioids [mg], non-opioids [mg]	Day 4 after surgery
Secondary	Postoperative mobilization	steps per day as measured with an activity tracker	Day 7 after surgery
Secondary	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
Secondary	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
Secondary	Daily postoperative pain	Postoperative pain according to a numeric rating scale measured daily from postoperative day 1-7	Day 7 after surgery