Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT06067620
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2023-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Robotic Right Hemicolectomy Versus Laparoscopic Right Hemicolectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-09', 'studyFirstSubmitDate': '2023-09-11', 'studyFirstSubmitQcDate': '2023-10-02', 'lastUpdatePostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first passage of faeces', 'timeFrame': 'From index surgical procedure (skin closure) until time of first passage of faeces, during hospitalisation, on average during the first 7 post-operative days', 'description': 'Measured in hours, starting at the skin closure of the index surgery'}], 'secondaryOutcomes': [{'measure': 'Duration of surgery', 'timeFrame': 'From skin incision to skin closure, during index surgical procedure', 'description': 'Measured in minutes'}, {'measure': 'Blood loss', 'timeFrame': 'From skin incision to skin closure, during index surgical procedure', 'description': 'Measured in ml'}, {'measure': 'Intra-operative transfusion', 'timeFrame': 'From skin incision to skin closure, during index surgical procedure', 'description': 'Number of patients who received blood and/or blood products transfusion'}, {'measure': 'Intra-operative complication', 'timeFrame': 'From skin incision to skin closure, during index surgical procedure', 'description': 'Number of patients who experienced a complication during the index surgery'}, {'measure': 'Conversion to open surgery', 'timeFrame': 'From skin incision to skin closure, during index surgical procedure', 'description': 'Number of patients who had conversion to open surgery; defined as an extraction site longer than 10cm'}, {'measure': 'Length of the extraction site', 'timeFrame': 'At post-operative day 30', 'description': 'Measured in centimeters'}, {'measure': 'Creation of a stoma', 'timeFrame': 'From skin incision to skin closure, during index surgical procedure', 'description': 'Number of patients who received a stoma during the index surgery'}, {'measure': 'Hb, WBC and CRP', 'timeFrame': 'At post-operative day 1, post-operative day 2, post-operative day 3, post-operative day 4 and post-operative day 5', 'description': 'Blood tests'}, {'measure': 'Time to first passage of flatus', 'timeFrame': 'From index surgical procedure (skin closure) until time of first passage of flatus, during hospitalisation, on average during the first 7 post-operative days', 'description': 'Measured in hours, starting at the skin closure of the index surgery'}, {'measure': 'In-hospital postoperative ileus', 'timeFrame': 'During hospitalisation, on average during the first 5 post-operative days', 'description': 'Number of patients who experienced a post-operative ileus which required the insertion of a nasogastric tube'}, {'measure': 'Length of stay', 'timeFrame': 'From the first day of hospitalisation to the day of discharge, on average during the first 10 post-operative days', 'description': 'Measured in days'}, {'measure': 'Post-operative morbidity', 'timeFrame': 'From index surgical procedure (skin closure) to post-operative day 30', 'description': 'Number of patients who experienced post-operative morbidity, as measured by the Clavien-Dindo scale'}, {'measure': 'Surgical site infection', 'timeFrame': 'From index surgical procedure (skin closure) to post-operative day 7 and post-operative day 30', 'description': 'Number of patients who experienced surgical site infection'}, {'measure': 'Anastomotic leak', 'timeFrame': 'From index surgical procedure (skin closure) to post-operative day 30', 'description': 'Number of patients who experienced anastomotic leak, with radiological and/or surgical confirmation'}, {'measure': 'Re-intervention', 'timeFrame': 'From index surgical procedure (skin closure) to post-operative day 30', 'description': 'Number of patients who required a surgical re-intervention associated with the index surgery'}, {'measure': 'Mortality', 'timeFrame': 'From index surgical procedure (skin closure) to post-operative day 30', 'description': 'Number of patients who experienced mortality'}, {'measure': 'Proximal margin', 'timeFrame': 'Within 10 days from the index surgical procedure', 'description': 'Measured in centimeters, on the operative specimen of the index surgery'}, {'measure': 'Distal margin', 'timeFrame': 'Within 10 days from the index surgical procedure', 'description': 'Measured in centimeters, on the operative specimen of the index surgery'}, {'measure': 'Harvested lymph nodes', 'timeFrame': 'Within 10 days from the index surgical procedure', 'description': 'Number of harvested lymph nodes, on the operative specimen of the index surgery'}, {'measure': 'Histology of the tumor/polyp', 'timeFrame': 'Within 10 days from the index surgical procedure', 'description': 'Type of cancer and/or polyp, based on the operative specimen of the index surgery'}, {'measure': 'TNM stage', 'timeFrame': 'Within 10 days from the index surgical procedure', 'description': '8th edition of the UICC TNM classification, based on the operative specimen of the index'}, {'measure': 'Bowel function', 'timeFrame': 'At post-operative day 30 and post-operative year 1', 'description': 'Gastrointestinal Quality of Life Index (GQLI)'}, {'measure': 'Quality of recovery', 'timeFrame': 'At post-operative hour 12, post-operative day 1, post-operative day 2, post-operative day 3, post-operative day 4, post-operative day 5 and post-operative day 7', 'description': 'Quality of Recovery-15 (QoR-15) score'}, {'measure': 'Aesthetic numeric analogue scale (ANA-scale)', 'timeFrame': 'At post-operative day 30 and post-operative year 1', 'description': 'Measuring the patient-reported esthetical aspect of the surgical wounds'}, {'measure': 'Incidence of incisional hernia', 'timeFrame': 'At post-operative year 1', 'description': 'Overall, and at extraction site; measured clinically and by CT'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Neoplasms', 'Colorectal Neoplasms Malignant', 'Colorectal Neoplasms, Benign', 'Colorectal Cancer', 'Colorectal Polyp', 'Colorectal Adenoma', 'Colorectal Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'Robotic right hemicolectomy with intra-corporeal anastomosis may have better short-term recovery outcomes and decreased incidence of incisional hernia when compared to the laparoscopic actual standard of care, for similar safety outcomes.', 'detailedDescription': 'During laparoscopic right hemicolectomy (lapRHC) for cancer or polyp, intra-corporeal anastomosis (ICA) offers better short-term recovery and decreased incidence of incisional hernia (IH) when compared to extra-corporeal anastomosis (ECA). However, because of the technical limitations of laparoscopy, ICA has not gained in wide acceptance and ECA has remained the standard of care. On the contrary, robotics offers improved suturing capacities and facilitates the realization of ICA. Therefore, robotic right hemicolectomy (robRHC) with ICA may have better short-term recovery outcomes and decreased incidence of IH when compared to the laparoscopic actual standard of care. In a randomized controlled trial, we will compare robRHC with ICA with lapRHC with ECA, in terms of recovery of bowel function (time to first passage of faeces). Secondary outcomes will notably include length of stay, incidence of IH, patient-reported esthetical outcomes and safety outcomes (morbidity, mortality, proximal and distal margins, harvested lymph nodes).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients requiring elective minimally invasive RHC for cT1-T3 Nx M0 cancer of the right colon (including cancer of the appendix, caecum, ascending colon and hepatic flexure).\n\nExclusion Criteria:\n\n* Not scheduled for minimally invasive RHC (refuses surgery and/or planned open approach)\n* Emergency surgery\n* Hereditary colorectal cancer\n* Inflammatory bowel disease\n* Synchronous resection of (an)other organ(s)\n* Synchronous surgical procedure (including more extended resection of the lower gastrointestinal tract)\n* cT4\n* cM+\n* History of laparotomy\n* Pregnancy\n* No anastomosis planned\n* Unable to provide informed consent\n* No informed consent'}, 'identificationModule': {'nctId': 'NCT06067620', 'acronym': 'PRORHEM', 'briefTitle': 'Robotic Right Hemicolectomy Versus Laparoscopic Right Hemicolectomy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Robotic Right Hemicolectomy With Intracorporeal Anastomosis Versus Laparoscopic Right Hemicolectomy With Extracorporeal Anastomosis (PRORHEM): a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'PRORHEM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Robotic right hemicolectomy', 'description': 'Robotic right hemicolectomy with intracorporeal anastomosis and extraction through a C-section (fully minimally invasive right hemicolectomy)', 'interventionNames': ['Procedure: Robotic right hemicolectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Laparoscopic right hemicolectomy', 'description': 'Laparoscopic right hemicolectomy with extracorporeal anastomosis and extraction through midline (standard of care)', 'interventionNames': ['Procedure: Laparoscopic right hemicolectomy']}], 'interventions': [{'name': 'Robotic right hemicolectomy', 'type': 'PROCEDURE', 'description': 'Robotic right hemicolectomy with intracorporeal anastomosis and extraction through a C-section, using the Da Vinci Xi.', 'armGroupLabels': ['Robotic right hemicolectomy']}, {'name': 'Laparoscopic right hemicolectomy', 'type': 'PROCEDURE', 'description': 'Laparoscopic right hemicolectomy with extracorporeal anastomosis and extraction through midline.', 'armGroupLabels': ['Laparoscopic right hemicolectomy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jeremy Meyer, MD, MD-PhD', 'role': 'CONTACT', 'email': 'jeremy.meyer@hcuge.ch', 'phone': '+41795533248'}], 'overallOfficials': [{'name': 'Christian Toso, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospitals of Geneva'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jeremy Meyer', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Geneva', 'class': 'OTHER'}, {'name': 'Spital Biel, Switzerland', 'class': 'UNKNOWN'}, {'name': 'Hôpital Fribourgeois', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Jeremy Meyer', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}