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Following a safety analysis and assessment of the complications encountered by external experts, it was decided to terminate recruitment prematurely
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| Name | Class |
|---|---|
| German Cancer Research Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A - Early removal of chest drain | Experimental |
| |
| B - Control | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early removal of chest drain | Procedure | Chest drains are removed 3 hours after the end of surgery in absence of contraindications in arm A. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | Postoperative pain according to a numeric rating scale | Day 2 after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Mean postoperative pain | Postoperative pain according to a numeric rating scale | Day 4 after surgery |
| Additional analgesic drug use | opioids [mg], non-opioids [mg] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johanna Kirchberg, Dr. med. | Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden | Dresden | Saxony | 01307 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37127683 | Derived | 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. |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015505 | Chest Tubes |
| ID | Term |
|---|---|
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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Randomized controlled multicentric trial
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| Chest drain | Procedure | The chest drains in arm B are removed during the further postoperative course according to standard algorithm. |
|
| Day 4 after surgery |
| Postoperative mobilization | steps per day as measured with an activity tracker | Day 7 after surgery |
| 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 |
| 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 |
| Daily postoperative pain | Postoperative pain according to a numeric rating scale measured daily from postoperative day 1-7 | Day 7 after surgery |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |