Ignite Creation Date:
2025-12-24 @ 2:02 PM
Ignite Modification Date:
2026-01-04 @ 3:41 AM
Study NCT ID:
NCT05553795
Status:
TERMINATED
Last Update Posted:
2024-06-13
First Post:
2022-08-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drainless Robot-assisted Minimally Invasive Esophagectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015505', 'term': 'Chest Tubes'}], 'ancestors': [{'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled multicentric trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'whyStopped': 'Following a safety analysis and assessment of the complications encountered by external experts, it was decided to terminate recruitment prematurely', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-12', 'studyFirstSubmitDate': '2022-08-19', 'studyFirstSubmitQcDate': '2022-09-22', 'lastUpdatePostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': 'Day 2 after surgery', 'description': 'Postoperative pain according to a numeric rating scale'}], 'secondaryOutcomes': [{'measure': 'Mean postoperative pain', 'timeFrame': 'Day 4 after surgery', 'description': 'Postoperative pain according to a numeric rating scale'}, {'measure': 'Additional analgesic drug use', 'timeFrame': 'Day 4 after surgery', 'description': 'opioids \\[mg\\], non-opioids \\[mg\\]'}, {'measure': 'Postoperative mobilization', 'timeFrame': 'Day 7 after surgery', 'description': 'steps per day as measured with an activity tracker'}, {'measure': 'Postoperative morbidity', 'timeFrame': 'Through hospital stay, an average of 14 days', 'description': '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'}, {'measure': 'Postoperative mortality', 'timeFrame': 'Through hospital stay, an average of 14 days', 'description': 'The postoperative mortality of all patients is assessed between operation date and date of death of any cause during hospital stay'}, {'measure': 'Daily postoperative pain', 'timeFrame': 'Day 7 after surgery', 'description': 'Postoperative pain according to a numeric rating scale measured daily from postoperative day 1-7'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Esophagectomy', 'Enhanced Recovery after Surgery (ERAS)', 'Robot-assisted minimally invasive esophagectomy (RAMIE)'], 'conditions': ['Esophageal Cancer']}, 'referencesModule': {'references': [{'pmid': '37127683', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for elective RAMIE for esophageal cancer with intrathoracic esophagogastrostomy (Ivor-Lewis)\n* American Society of Anesthesiologists (ASA) score ≤ III\n* Eastern Cooperative of Oncology Group (ECOG) status ≤ II\n* Patient suitable for both surgical techniques\n* Ability of subject to understand character and individual consequences of the clinical trial\n* Written informed consent\n\nExclusion Criteria:\n\n* Open esophagectomy (either abdominal or during the thoracic part)\n* Emergency operations\n* ASA IV\n* ECOG \\> II\n* Chronic pain syndromes requiring routine analgesics\n* Simultaneous lung resection\n* Presence of contraindications to the use of epidural anesthesia (e.g. coagulopathies, anticoagulation or allergies)\n* Participation in an interventional trial, which interferes with the outcome\n* Impaired mental state'}, 'identificationModule': {'nctId': 'NCT05553795', 'acronym': 'RESPECT', 'briefTitle': 'Drainless Robot-assisted Minimally Invasive Esophagectomy', 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'officialTitle': 'Drainless Robot-assisted Minimally Invasive Esophagectomy', 'orgStudyIdInfo': {'id': 'VTG-11'}}, 'armsInterventionsModule': {'armGroups': [{'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']}], 'interventions': [{'name': 'Early removal of chest drain', 'type': 'PROCEDURE', 'description': 'Chest drains are removed 3 hours after the end of surgery in absence of contraindications in arm A.', 'armGroupLabels': ['A - Early removal of chest drain']}, {'name': 'Chest drain', 'type': 'PROCEDURE', 'description': 'The chest drains in arm B are removed during the further postoperative course according to standard algorithm.', 'armGroupLabels': ['B - Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01307', 'city': 'Dresden', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}], 'overallOfficials': [{'name': 'Johanna Kirchberg, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Cancer Research Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}