Ignite Creation Date:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2025-12-26 @ 10:43 PM
Study NCT ID:
NCT05832112
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-16
First Post:
2023-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outside the Cage (OTC) Robotic Lobectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-12-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-15', 'studyFirstSubmitDate': '2023-02-13', 'studyFirstSubmitQcDate': '2023-04-14', 'lastUpdatePostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Conversion rate', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Feasibility will be evaluated by completion of the procedure without conversion of the approach or technique. Any change in the treatment plan requiring the use of intercostal ports, conversion to conventional minimally invasive thoracic surgery through intercostal incisions, or conversion to open surgery'}, {'measure': '30-day mortality', 'timeFrame': '30 days after discharge', 'description': 'Safety will be evaluated by 30-day mortality. Any dead occurring during the hospital stay or within 30 days after discharge will be registered.'}], 'secondaryOutcomes': [{'measure': 'Length of stay', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Length of hospital stay'}, {'measure': 'Operative time', 'timeFrame': 'Intraoperative', 'description': 'Surgical operative time including robot positioning'}, {'measure': 'Estimated blood loss', 'timeFrame': 'Intraoperative', 'description': 'Registered by the OR nurse team'}, {'measure': 'Postoperative pain', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Pain scores on a visual analog scale: Pain Rating Scale between 0 and 10 (0: better outcome and 10:Worse outcome)'}, {'measure': 'Quality of recovery', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Assessment of postoperative recovery using Quality Of Recovery (QOR-15) questionnaire between 0 and 10 (0: Better outcome and 10: Worst outcome)'}, {'measure': 'Analgesic complementation requirement', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Number of participants who need of adding analgesia medication out of the analgesic pathway used in our center for conventional RATS/VATS'}, {'measure': 'Serious adverse events', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Complications derived from the operation that altered the pathway'}, {'measure': 'Perioperative complications', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Complications including intraoperative and postoperative occurring during the hospital stay or within 30 days after discharge will be graded according to the Clavien-Dindo classification'}, {'measure': 'Evaluate Chronic Pain', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Pain scores on a visual analog scale: Pain Rating Scale between 0 and 10 (0: better outcome and 10:Worse outcome).\n\nChronic pain of OTC RATS lobectomy patients will be compared to that of VATS lobectomy patients, for which the data will also be collected and analysed retrospectively.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Out of the Cage', 'Lobectomy', 'Robotic'], 'conditions': ['Lung Cancer Stage I']}, 'descriptionModule': {'briefSummary': 'This study consists in a prospective pilot study evaluating the feasibility and safety of OTC RATS lobectomies in patients treated for lung cancer. All patients with clinical stage I tumors (≤cT2N0M0) planned to undergo a VATS or RATS lobectomy at the CHUM will be approached. At our institution, lobectomies are either performed open by thoracotomy or by MIS, including VATS and RATS. The technique is selected based on tumor size, tumor location and patient characteristics. Only patients already planned for a VATS or RATS lobectomy will be approached. They will be identified through the operation request forms and will be approached either in the preoperative clinic or the day before surgery, when admitted. The investigators aim to recruit 20 patients.', 'detailedDescription': 'Consenting patients will undergo lobectomy by OTC RATS following the exact standard steps usually done by VATS/RATS, aside from the ports that will be placed in the subcostal plane. The characteristics of both the patient and the case, will determine the number of incisions from 1-4.\n\nThe Davinci Xi® surgical system will be used to perform the lobectomy through the ports using the standard technique with an anterior approach. Once the procedure is completed, the robotic arms and ports will be removed from the chest and figure-of-8 stitches with non absorbable sutures will be placed to close the diaphragm at the site of insertion. A 24 Fr soft chest tube will be left in place, as in the standard VATS/RATS lobectomy procedure. The incision closure will be done in a standard manner.\n\nEnrolled patients will receive standard postoperative care. Chest tube removal and discharge will be decided by the treating surgeon, following the same criteria as VATS/RATS lobectomies. Images and videos will be recorded during the procedure. The postoperative course will be monitored in case of potential complications up to the 30-day follow-up appointment. Medical records will be verified to obtain postoperative outcomes at follow-up appointments at the surgical clinic.\n\nAll data pertaining to the 1-year follow-up will be collected and analysed retrospectively. Chronic pain of OTC RATS lobectomy patients will be compared to that of VATS lobectomy patients, for which the data will also be collected and analysed retrospectively. A propensity match score will be conducted using the two groups of patients, divided by surgical approach, to adequately interpret the degree of chronic pain experienced by patients who have received surgery using an OTC approach versus the current minimally invasive thoracic approach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with clinical stage I tumors (≤cT2N0M0) planned to undergo a lobectomy by VATS/RATS at the CHUM\n\nExclusion Criteria:\n\n* Age \\< 18 years old\n* Inability to consent to the study\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT05832112', 'acronym': 'OTC-RATS', 'briefTitle': 'Outside the Cage (OTC) Robotic Lobectomy', 'organization': {'class': 'OTHER', 'fullName': "Centre hospitalier de l'Université de Montréal (CHUM)"}, 'officialTitle': 'Outside the Cage (OTC) Robotic Lobectomy, Single Center Human Phase I Trial', 'orgStudyIdInfo': {'id': '22.228'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Out of the Cage Robotic Lobectomy', 'description': 'Consented patients will undergo lobectomy by OTC RATS following the exact standard steps usually done by VATS/RATS, except for the incisions, that will consist in 1 to 4 subcostal ports, based on the patient and case characteristics.', 'interventionNames': ['Procedure: VATS/RATS lobectomy']}], 'interventions': [{'name': 'VATS/RATS lobectomy', 'type': 'PROCEDURE', 'description': 'Consenting patients will undergo lobectomy by OTC RATS following the exact standard steps usually done by VATS/RATS, aside from the ports that will be placed in the subcostal plane. The characteristics of both the patient and the case, will determine the number of incisions from 1-4.\n\nThe Davinci Xi® surgical system will be used to perform the lobectomy through the ports using the standard technique with an anterior approach. Once the procedure is completed, the robotic arms and ports will be removed from the chest and figure-of-8 stitches with non absorbable sutures will be placed to close the diaphragm at the site of insertion. A 24 Fr soft chest tube will be left in place, as in the standard VATS/RATS lobectomy procedure. The incision closure will be done in a standard manner.', 'armGroupLabels': ['Out of the Cage Robotic Lobectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H2X 0A9', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHUM', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Moishe Liberman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre hospitalier de l'Université de Montréal (CHUM)"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre hospitalier de l'Université de Montréal (CHUM)", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}