Clinical trial · Interventional
Drainless Robot-assisted Minimally Invasive Esophagectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Following a safety analysis and assessment of the complications encountered by external experts, it was decided to terminate recruitment prematurely
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chest drain | Procedure | — | UNRESOLVED |
| Early removal of chest drain | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A - Early removal of chest drain
- interventionNames
- Procedure: Early removal of chest drain
- type
- OTHER
- label
- B - Control
- interventionNames
- Procedure: Chest drain
Primary outcomes (1)
- measure
- Postoperative pain
- timeFrame
- Day 2 after surgery
- description
- Postoperative pain according to a numeric rating scale
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMussle 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