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Clinical Trials/NCT06622720
NCT06622720
Completed
Not Applicable

Laparoscopic Elective Colorectal Procedures Performed by Supervised Residents Are Safe and Sufficient.

Jagiellonian University1 site in 1 country498 target enrollmentStarted: January 1, 2022Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Jagiellonian University
Enrollment
498
Locations
1
Primary Endpoint
Rate of complete resections

Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • The rate of readmissions(1st January 2021 - 31th December 2023)
  • The rate of anastomosis leaks(1st January 2021 - 31th December 2023)
  • The rate of postoperative ileus(1st January 2021 - 31th December 2023)
  • The rate of reoperations(1st January 2021 - 31th December 2023)
  • The rate of surgical site infection(1st January 2021 - 31th December 2023)
  • Mortality(1st January 2021 - 31th December 2023)

Investigators

Sponsor
Jagiellonian University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Zofia Orzeszko

MD

Jagiellonian University

Study Sites (1)

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