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

NCT06622720 | Completed DMC

• 1 other identifier: 2024.000.463
• Study Type: observational
• Target: 498
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Training; Residency

Keywords

Colorectal Cancer; Surgical Training; Residency; Colorectal Surgery

Outcome Measures

Primary Outcomes (4)

• Rate of complete resections

  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

  Reported number of lymph nodes in histopathological result

  1st January 2021 - 31th December 2023

• The duration of surgery

  Reported surgery time

  1st January 2021 - 31th December 2023

• The length of hospital stay

  Reported days in hospital

  1st January 2021 - 31th December 2023

Secondary Outcomes (6)

• 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

Study Arms (2)

Residents

Individuals undergoing elective colorectal resection due to cancer performed by residents between January 2022 and December 2023.

Procedure: surgery

Colorectal surgeons

Individuals undergoing elective colorectal resection due to cancer performed by experienced colorectal surgeons between January 2022 and December 2023.

Procedure: surgery

Interventions

surgery PROCEDURE

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

Colorectal surgeons; Residents

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• all individuals undergoing elective colorectal resection due to cancer between January 2022 and December 2023 in a single colorectal center.

You may not qualify if:

• stoma creation
• a history of inflammatory bowel disease
• a history of bowel resection

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Hospital of St John of God

Krakow, Lesser Poland Voivodeship, 31061, Poland

Location

Related Publications (7)

• 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.

  PMID: 31445669 BACKGROUND

• 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.

  PMID: 30342854 BACKGROUND

• 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.

  PMID: 35697242 BACKGROUND

• 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.

  PMID: 27704242 BACKGROUND

• 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.

  PMID: 23135590 BACKGROUND

• 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.

  PMID: 35978712 BACKGROUND

• 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.

  PMID: 22513427 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Mirosław Szura, Prof, PhD

  Jagiellonian University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 2, 2024
• Study Start: January 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)