Surgical TrainingNCT06622720
Laparoscopic Elective Colorectal Procedures Performed by Supervised Residents Are Safe and Sufficient.
An observational study of Surgical Training and Residency, run by Jagiellonian University at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Training, Residency
- What is being tested?
- surgery
- Type of treatment
- Surgery or procedure
- How many people
- 498 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- all individuals undergoing elective colorectal resection due to cancer between January 2022 and December 2023 in a single colorectal center.
Who cannot join
- stoma creation
- a history of inflammatory bowel disease
- a history of bowel resection
Trial locations and contacts
1 site in 1 country.
Poland1 site
Hospital of St John of God
Krakow, Lesser Poland Voivodeship, 31061
About this study
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.
Read the 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.
- Conditions
- Surgical Training, Residency
- Being tested
- surgery
- Keywords
- Colorectal Cancer, Surgical Training, Residency, Colorectal Surgery
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryProcedure or surgery
The colorectal surgery of any type conducted in any approach in the timeframe
| Study group | Role | What they receive |
|---|---|---|
| Residents | Individuals undergoing elective colorectal resection due to cancer performed by residents between January 2022 and December 2023. Receives: Procedure: surgery | |
| Colorectal surgeons | Individuals undergoing elective colorectal resection due to cancer performed by experienced colorectal surgeons between January 2022 and December 2023. Receives: Procedure: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complete resections
Resection is noted as complete (R0) when resection margins are clear from cancer infiltration microscopically and macroscopically.
Measured: 1st January 2021 - 31th December 2023
The number of resected lymph nodes
Reported number of lymph nodes in histopathological result
Measured: 1st January 2021 - 31th December 2023
The duration of surgery
Reported surgery time
Measured: 1st January 2021 - 31th December 2023
The length of hospital stay
Reported days in hospital
Measured: 1st January 2021 - 31th December 2023
Secondary outcomes (6)
The rate of readmissions
Reported number of readmissions
Measured: 1st January 2021 - 31th December 2023
The rate of anastomosis leaks
Reported number of anastomosis leaks
Measured: 1st January 2021 - 31th December 2023
The rate of postoperative ileus
Reported number of postoperative ileus
Measured: 1st January 2021 - 31th December 2023
The rate of reoperations
The number of reoperations at any cause associated with primary surgery (both surgical and endoscopic interventions).
Measured: 1st January 2021 - 31th December 2023
The rate of surgical site infection
Reported number of surgical site infection
Measured: 1st January 2021 - 31th December 2023
Mortality
Reported mortality
Measured: 1st January 2021 - 31th December 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start1 Jan 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Surgical TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 498 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zofia Orzeszko, Jagiellonian University
- Investigators
- Mirosław Szura, Prof, PhD, Study chair, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622720
- Sponsor's protocol ID
- 2024.000.463
- Status last verified
- Jan 2025
- First submitted
- 29 Sep 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will not be shared.
Publications
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.
PubMed 31445669Saraidaridis 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.
PubMed 30342854Bustamante 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.
PubMed 35697242Nijhof 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.
PubMed 27704242Miskovic 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.
PubMed 23135590Perivoliotis 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.
PubMed 35978712Fox 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.
PubMed 22513427
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Elective Colorectal Procedures Performed by Supervised Residents Are Safe and Sufficient.
- ClinicalTrials.gov ID
- NCT06622720
- Acronym / sponsor ID
- 2024.000.463
- Conditions
- Surgical Training, Residency
- Keywords
- Colorectal Cancer, Surgical Training, Residency, Colorectal Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 498 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Residents | – | Procedure: surgeryIndividuals undergoing elective colorectal resection due to cancer performed by residents between January 2022 and December 2023. |
| Colorectal surgeons | – | Procedure: surgeryIndividuals undergoing elective colorectal resection due to cancer performed by experienced colorectal surgeons between January 2022 and December 2023. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- all individuals undergoing elective colorectal resection due to cancer between January 2022 and December 2023 in a single colorectal center.
Key exclusion criteria (3 listed)
- stoma creation
- a history of inflammatory bowel disease
- a history of bowel resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgeryThe colorectal surgery of any type conducted in any approach in the timeframe | Procedure or surgery | Colorectal surgeons, Residents |
Primary outcome
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.
The number of resected lymph nodes
Time frame: 1st January 2021 - 31th December 2023
Reported number of lymph nodes in histopathological result
The duration of surgery
Time frame: 1st January 2021 - 31th December 2023
Reported surgery time
The length of hospital stay
Time frame: 1st January 2021 - 31th December 2023
Reported days in hospital
6 secondary outcomes
The rate of readmissions
Time frame: 1st January 2021 - 31th December 2023
The rate of anastomosis leaks
Time frame: 1st January 2021 - 31th December 2023
The rate of postoperative ileus
Time frame: 1st January 2021 - 31th December 2023
The rate of reoperations
Time frame: 1st January 2021 - 31th December 2023
The rate of surgical site infection
Time frame: 1st January 2021 - 31th December 2023
Mortality
Time frame: 1st January 2021 - 31th December 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Background: PubMed 31445669Ofshteyn 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.
- Background: PubMed 30342854Saraidaridis 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.
- Background: PubMed 35697242Bustamante 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.
- Background: PubMed 27704242Nijhof 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.
- Background: PubMed 23135590Miskovic 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.
- Background: PubMed 35978712Perivoliotis 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.
- Background: PubMed 22513427Fox 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.
- Individual participant dataSharing planned: No. The data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mirosław Szura, Prof, PhD study chair
Jagiellonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Training and Residency, run by Jagiellonian University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of complete resections (time frame: 1st January 2021 - 31th December 2023). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06622720, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025; AzTrials last refreshed its copy on 1 Nov 2026.