Clinical trial NCT06622720: Laparoscopic Elective Colorectal Procedures Performed by Supervised Residents Are Safe and Sufficient.
Official title: Laparoscopic Elective Colorectal Procedures Performed by Supervised Residents Are Safe and Sufficient.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Training
Residency
Keywords: Colorectal Cancer
Surgical Training
Residency
Colorectal Surgery
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 498
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study included all adult individuals undergoing elective colorectal resection due to cancer between January 2022 and December 2023 in a single colorectal center.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* all individuals undergoing elective colorectal resection due to cancer between January 2022 and December 2023 in a single colorectal center.

Exclusion Criteria:

* stoma creation
* a history of inflammatory bowel disease
* a history of bowel resection

Primary outcomes:
measure: Rate of complete resections
timeFrame: 1st January 2021 - 31th December 2023
measure: The number of resected lymph nodes
timeFrame: 1st January 2021 - 31th December 2023
measure: The duration of surgery
timeFrame: 1st January 2021 - 31th December 2023
measure: The length of hospital stay
timeFrame: 1st January 2021 - 31th December 2023
Secondary outcomes:
measure: The rate of readmissions
timeFrame: 1st January 2021 - 31th December 2023
measure: The rate of anastomosis leaks
timeFrame: 1st January 2021 - 31th December 2023
measure: The rate of postoperative ileus
timeFrame: 1st January 2021 - 31th December 2023
measure: The rate of reoperations
timeFrame: 1st January 2021 - 31th December 2023
measure: The rate of surgical site infection
timeFrame: 1st January 2021 - 31th December 2023
measure: Mortality
timeFrame: 1st January 2021 - 31th December 2023
Other outcomes:
Locations:
city: Cracovia
country: Poland
facility: Hospital of St John of God
state: Lesser Poland
Study officials:
affiliation: Jagiellonian University
name: Mirosław Szura, Prof, PhD
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.
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.