Drainless Robot-assisted Minimally Invasive Esophagectomy

NCT05553795 | Terminated DMC

• 1 other identifier: VTG-11
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer

Keywords

Esophagectomy; Enhanced Recovery after Surgery (ERAS); Robot-assisted minimally invasive esophagectomy (RAMIE)

Outcome Measures

Primary Outcomes (1)

• Postoperative pain

  Postoperative pain according to a numeric rating scale

  Day 2 after surgery

Secondary Outcomes (6)

• Mean postoperative pain

  Day 4 after surgery

• Additional analgesic drug use

  Day 4 after surgery

• Postoperative mobilization

  Day 7 after surgery

• Postoperative morbidity

  Through hospital stay, an average of 14 days

• Postoperative mortality

  Through hospital stay, an average of 14 days

Study Arms (2)

A - Early removal of chest drain

EXPERIMENTAL

Procedure: Early removal of chest drain

B - Control

OTHER

Procedure: Chest drain

Interventions

Early removal of chest drain PROCEDURE

Chest drains are removed 3 hours after the end of surgery in absence of contraindications in arm A.

A - Early removal of chest drain

Chest drain PROCEDURE

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

B - Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technische Universität Dresden: lead
• German Cancer Research Center: collaborator

Study Sites (1)

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

Dresden, Saxony, 01307, Germany

Location

Related Publications (1)

• Mussle B, Kirchberg J, Buck N, Radulova-Mauersberger O, Stange D, Richter T, Muller-Stich B, Klotz R, Larmann J, Korn S, Klimova A, Grahlert X, Trips E, Weitz J, Welsch T. Drainless robot-assisted minimally invasive oesophagectomy-randomized controlled trial (RESPECT). Trials. 2023 May 2;24(1):303. doi: 10.1186/s13063-023-07233-z.

  PMID: 37127683 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Chest Tubes

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Officials

• Johanna Kirchberg, Dr. med.

  Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled multicentric trial

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: September 23, 2022
• Study Start: April 19, 2023
• Primary Completion: May 21, 2024
• Study Completion: May 21, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)