Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:26 AM
Study NCT ID:
NCT06622720
Status:
COMPLETED
Last Update Posted:
2025-01-24
First Post:
2024-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Laparoscopic Elective Colorectal Procedures Performed by Supervised Residents Are Safe and Sufficient.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 498}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-22', 'studyFirstSubmitDate': '2024-09-29', 'studyFirstSubmitQcDate': '2024-09-29', 'lastUpdatePostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of complete resections', 'timeFrame': '1st January 2021 - 31th December 2023', 'description': 'Resection is noted as complete (R0) when resection margins are clear from cancer infiltration microscopically and macroscopically.'}, {'measure': 'The number of resected lymph nodes', 'timeFrame': '1st January 2021 - 31th December 2023', 'description': 'Reported number of lymph nodes in histopathological result'}, {'measure': 'The duration of surgery', 'timeFrame': '1st January 2021 - 31th December 2023', 'description': 'Reported surgery time'}, {'measure': 'The length of hospital stay', 'timeFrame': '1st January 2021 - 31th December 2023', 'description': 'Reported days in hospital'}], 'secondaryOutcomes': [{'measure': 'The rate of readmissions', 'timeFrame': '1st January 2021 - 31th December 2023', 'description': 'Reported number of readmissions'}, {'measure': 'The rate of anastomosis leaks', 'timeFrame': '1st January 2021 - 31th December 2023', 'description': 'Reported number of anastomosis leaks'}, {'measure': 'The rate of postoperative ileus', 'timeFrame': '1st January 2021 - 31th December 2023', 'description': 'Reported number of postoperative ileus'}, {'measure': 'The rate of reoperations', 'timeFrame': '1st January 2021 - 31th December 2023', 'description': 'The number of reoperations at any cause associated with primary surgery (both surgical and endoscopic interventions).'}, {'measure': 'The rate of surgical site infection', 'timeFrame': '1st January 2021 - 31th December 2023', 'description': 'Reported number of surgical site infection'}, {'measure': 'Mortality', 'timeFrame': '1st January 2021 - 31th December 2023', 'description': 'Reported mortality'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colorectal Cancer', 'Surgical Training', 'Residency', 'Colorectal Surgery'], 'conditions': ['Surgical Training', 'Residency']}, 'referencesModule': {'references': [{'pmid': '31445669', 'type': 'BACKGROUND', 'citation': 'Ofshteyn A, Terry M, Bingmer K, Stein SL, Steinhagen E. General surgery resident experience with anorectal surgery. Am J Surg. 2020 Jun;219(6):993-997. doi: 10.1016/j.amjsurg.2019.08.010. Epub 2019 Aug 17.'}, {'pmid': '30342854', 'type': 'BACKGROUND', 'citation': 'Saraidaridis JT, Read TE, Marcello PW, Schoetz DJ, Rusin LC, Kleiman DA, Melnitchouk N, Roberts PL, Breen EM. What do Young Colorectal Surgeons Value From Their CRS Residency Training? J Surg Educ. 2019 May-Jun;76(3):720-726. doi: 10.1016/j.jsurg.2018.09.013. Epub 2018 Oct 17.'}, {'pmid': '35697242', 'type': 'BACKGROUND', 'citation': 'Bustamante Recuenco C, Alonso-Lamberti Rizo L, Salazar Carrasco A, Valle Rubio A, Cendrero Martin M, Jimenez Carneros V, Ramos Rodriguez JL, Jimenez Miramon FJ. Resident training in colorectal laparoscopic surgery: A retrospective morbidity, mortality and survival analysis of 408 cases in our environment. Cir Esp (Engl Ed). 2022 Sep;100(9):555-561. doi: 10.1016/j.cireng.2022.06.016. Epub 2022 Jun 11.'}, {'pmid': '27704242', 'type': 'BACKGROUND', 'citation': 'Nijhof HW, Silvis R, Vuylsteke RCLM, Oosterling SJ, Rijna H, Stockmann HBAC. Training residents in laparoscopic colorectal surgery: is supervised surgery safe? Surg Endosc. 2017 Jun;31(6):2602-2606. doi: 10.1007/s00464-016-5268-0. Epub 2016 Oct 4.'}, {'pmid': '23135590', 'type': 'BACKGROUND', 'citation': 'Miskovic D, Ni M, Wyles SM, Tekkis P, Hanna GB. Learning curve and case selection in laparoscopic colorectal surgery: systematic review and international multicenter analysis of 4852 cases. Dis Colon Rectum. 2012 Dec;55(12):1300-10. doi: 10.1097/DCR.0b013e31826ab4dd.'}, {'pmid': '35978712', 'type': 'BACKGROUND', 'citation': 'Perivoliotis K, Baloyiannis I, Mamaloudis I, Volakakis G, Valaroutsos A, Tzovaras G. Change point analysis validation of the learning curve in laparoscopic colorectal surgery: Experience from a non-structured training setting. World J Gastrointest Endosc. 2022 Jun 16;14(6):387-401. doi: 10.4253/wjge.v14.i6.387.'}, {'pmid': '22513427', 'type': 'BACKGROUND', 'citation': 'Fox J, Gross CP, Longo W, Reddy V. Laparoscopic colectomy for the treatment of cancer has been widely adopted in the United States. Dis Colon Rectum. 2012 May;55(5):501-8. doi: 10.1097/DCR.0b013e318249ce5a.'}]}, 'descriptionModule': {'briefSummary': 'The ability to perform laparoscopic colorectal surgery is an essential attribute of a general surgeon. Data on the participation of residents and the outcomes of colorectal procedures performed by surgeons in training are in demand. The objective of this study is to comprehensively investigate the outcomes of colorectal procedures performed by general surgery residents supervised by experienced colorectal surgeons and assess their previous laparoscopic experience.', 'detailedDescription': "The ability to perform laparoscopic colorectal surgery is an essential attribute of a general surgeon. Residents' contribution to colorectal procedures ranges from 33 to 40%. Few papers describe the outcomes of treatment provided by residents. The learning curve in colorectal techniques requires 88 to 152 cases to reach proficiency. Data on the participation of residents and the outcomes of procedures performed by surgeons in training are in demand. The objective of this study is to comprehensively investigate the outcomes of colorectal procedures performed by general surgery residents supervised by experienced colorectal surgeons and assess their previous laparoscopic experience. A retrospective single-center analysis was performed based on a review of database records. It included 498 elective colorectal procedures performed in a high-volume colorectal surgery center, where over 200 procedures are performed each year. The study included all individuals undergoing elective colorectal resection due to cancer between January 2022 and December 2023. 43 procedures were performed by residents and 455 by experienced colorectal surgeons. The procedures were performed by five experienced colorectal surgeons and three residents in their third to sixth year of surgical training. When performing evaluated procedures, residents were performed under the surveillance of experienced colorectal surgeons, according to Polish law requirements."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study included all adult individuals undergoing elective colorectal resection due to cancer between January 2022 and December 2023 in a single colorectal center.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all individuals undergoing elective colorectal resection due to cancer between January 2022 and December 2023 in a single colorectal center.\n\nExclusion Criteria:\n\n* stoma creation\n* a history of inflammatory bowel disease\n* a history of bowel resection'}, 'identificationModule': {'nctId': 'NCT06622720', 'briefTitle': 'Laparoscopic Elective Colorectal Procedures Performed by Supervised Residents Are Safe and Sufficient.', 'organization': {'class': 'OTHER', 'fullName': 'Jagiellonian University'}, 'officialTitle': 'Laparoscopic Elective Colorectal Procedures Performed by Supervised Residents Are Safe and Sufficient.', 'orgStudyIdInfo': {'id': '2024.000.463'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Residents', 'description': 'Individuals undergoing elective colorectal resection due to cancer performed by residents between January 2022 and December 2023.', 'interventionNames': ['Procedure: surgery']}, {'label': 'Colorectal surgeons', 'description': 'Individuals undergoing elective colorectal resection due to cancer performed by experienced colorectal surgeons between January 2022 and December 2023.', 'interventionNames': ['Procedure: surgery']}], 'interventions': [{'name': 'surgery', 'type': 'PROCEDURE', 'description': 'The colorectal surgery of any type conducted in any approach in the timeframe', 'armGroupLabels': ['Colorectal surgeons', 'Residents']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31061', 'city': 'Krakow', 'state': 'Lesser Poland Voivodeship', 'country': 'Poland', 'facility': 'Hospital of St John of God', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}], 'overallOfficials': [{'name': 'Mirosław Szura, Prof, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Jagiellonian University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data will not be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jagiellonian University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Zofia Orzeszko', 'investigatorAffiliation': 'Jagiellonian University'}}}}