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OpenTrials
Completed

NCT Number: NCT06622720

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital of St John of God

Krakow, Lesser Poland Voivodeship, 31061, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgery

Procedure

The colorectal surgery of any type conducted in any approach in the timeframe

Primary outcomes

  1. 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.

  2. The number of resected lymph nodes

    Time frame: 1st January 2021 - 31th December 2023

    Reported number of lymph nodes in histopathological result

  3. The duration of surgery

    Time frame: 1st January 2021 - 31th December 2023

    Reported surgery time

  4. The length of hospital stay

    Time frame: 1st January 2021 - 31th December 2023

    Reported days in hospital

Secondary outcomes

  1. The rate of readmissions

    Time frame: 1st January 2021 - 31th December 2023

    Reported number of readmissions

  2. The rate of anastomosis leaks

    Time frame: 1st January 2021 - 31th December 2023

    Reported number of anastomosis leaks

  3. The rate of postoperative ileus

    Time frame: 1st January 2021 - 31th December 2023

    Reported number of postoperative ileus

  4. 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).

  5. The rate of surgical site infection

    Time frame: 1st January 2021 - 31th December 2023

    Reported number of surgical site infection

  6. Mortality

    Time frame: 1st January 2021 - 31th December 2023

    Reported mortality

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 2, 2024
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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