- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06622720
Laparoscopic Elective Colorectal Procedures Performed by Supervised Residents Are Safe and Sufficient.
January 22, 2025 updated by: Zofia Orzeszko, Jagiellonian University
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.
Study Overview
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.
Study Type
Observational
Enrollment (Actual)
498
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Lesser Poland
-
Cracovia, Lesser Poland, Poland, 31061
- Hospital of St John of God
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Residents
Individuals undergoing elective colorectal resection due to cancer performed by residents between January 2022 and December 2023.
|
The colorectal surgery of any type conducted in any approach in the timeframe
|
|
Colorectal surgeons
Individuals undergoing elective colorectal resection due to cancer performed by experienced colorectal surgeons between January 2022 and December 2023.
|
The colorectal surgery of any type conducted in any approach in the timeframe
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of complete resections
Time Frame: 1st January 2021 - 31th December 2023
|
Resection is noted as complete (R0) when resection margins are clear from cancer infiltration microscopically and macroscopically.
|
1st January 2021 - 31th December 2023
|
|
The number of resected lymph nodes
Time Frame: 1st January 2021 - 31th December 2023
|
Reported number of lymph nodes in histopathological result
|
1st January 2021 - 31th December 2023
|
|
The duration of surgery
Time Frame: 1st January 2021 - 31th December 2023
|
Reported surgery time
|
1st January 2021 - 31th December 2023
|
|
The length of hospital stay
Time Frame: 1st January 2021 - 31th December 2023
|
Reported days in hospital
|
1st January 2021 - 31th December 2023
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The rate of readmissions
Time Frame: 1st January 2021 - 31th December 2023
|
Reported number of readmissions
|
1st January 2021 - 31th December 2023
|
|
The rate of anastomosis leaks
Time Frame: 1st January 2021 - 31th December 2023
|
Reported number of anastomosis leaks
|
1st January 2021 - 31th December 2023
|
|
The rate of postoperative ileus
Time Frame: 1st January 2021 - 31th December 2023
|
Reported number of postoperative ileus
|
1st January 2021 - 31th December 2023
|
|
The rate of reoperations
Time Frame: 1st January 2021 - 31th December 2023
|
The number of reoperations at any cause associated with primary surgery (both surgical and endoscopic interventions).
|
1st January 2021 - 31th December 2023
|
|
The rate of surgical site infection
Time Frame: 1st January 2021 - 31th December 2023
|
Reported number of surgical site infection
|
1st January 2021 - 31th December 2023
|
|
Mortality
Time Frame: 1st January 2021 - 31th December 2023
|
Reported mortality
|
1st January 2021 - 31th December 2023
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Mirosław Szura, Prof, PhD, Jagiellonian University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2022
Primary Completion (Actual)
December 31, 2023
Study Completion (Actual)
December 31, 2023
Study Registration Dates
First Submitted
September 29, 2024
First Submitted That Met QC Criteria
September 29, 2024
First Posted (Actual)
October 2, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 22, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 2024.000.463
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The data will not be shared.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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