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

Status

Completed

Intervention / Treatment

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.

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

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.

Clinical Trials on Surgical Training

Clinical Trials on surgery

Subscribe