Prospective Study
Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Oncol. Mar 15, 2025; 17(3): 102604
Published online Mar 15, 2025. doi: 10.4251/wjgo.v17.i3.102604
Stoma related complications: A registry study based on a prospective registration system
Nan Chen, Jie Zhang, Lin Wang, Qian Yang, Ai-Wen Wu
Nan Chen, Jie Zhang, Lin Wang, Qian Yang, Ai-Wen Wu, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Gastrointestinal Center, Unit III, Peking University Cancer Hospital and Institute, Beijing 100142, China
Co-first authors: Nan Chen and Jie Zhang.
Author contributions: Chen N and Zhang J contribute equally to this study as co-first authors; Wu AW designed the research study; Chen N, Zhang J performed the data collection, analysis and manuscript drafting; Yang Q performed the revision and patients’ follow-up; Wang L helped the revision of the manuscript.
Supported by Beijing Municipal Administration of Hospitals Incubating Program, No. PZ2020027; 2018 Beijing Talent Incubating Funding, No. 2018-4; National Natural Science Foundation of China, No. 81773214; Beijing Hospitals Authority Clinical Medicine Development of Special Funding Support, No. ZYLX202116; the National Key R&D Program of China, No. 2021YFF1201104; and Science Foundation of Peking University Cancer Hospital-2023, No. JC202310.
Institutional review board statement: The study was reviewed and approved by The Ethics Committee of Beijing Cancer Hospital (Approval No. 2024KT112).
Clinical trial registration statement: Although this study prospectively collected data and has been categorized as a prospective study, due to time constraints, we were unable to complete the registration process for a clinical trial, which involves multiple steps. Given that this study is observational in nature, we apply for a waiver from clinical trial registration despite having obtained ethical approval.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: There are no conflicts of interest among the authors.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Data sharing statement: No additional data are available.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Ai-Wen Wu, MD, PhD, Professor, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Gastrointestinal Center, Unit III, Peking University Cancer Hospital and Institute, No. 52 Fucheng Road, Haidian District, Beijing 100142, China. wuaw@sina.com
Received: November 13, 2024
Revised: December 22, 2024
Accepted: January 3, 2025
Published online: March 15, 2025
Processing time: 93 Days and 2.8 Hours
Abstract
BACKGROUND

Stoma creation is a common procedure in colorectal cancer surgery, however, stoma-related complications remain a significant concern.

AIM

To investigate the incidence, types, and risk factors of stoma-related complications in colorectal cancer patients who underwent stoma creation.

METHODS

Patients with stoma was prospectively recorded in the established stoma system. Data was collected from this stoma management system from November 2021 through May 2024. The rates of stoma-related complications were assessed, and potential risk factors were analyzed using univariate and multivariate logistic regression models.

RESULTS

A total of 734 patients were included in the analysis. The results showed that 12.3% of patients experienced stoma-related complications, with mucocutaneous separation, edema, and skin excoriation being the most common complications. The majority (90%) of complications were classified as grade 2 according to the Clavien-Dindo classification. Surgical factors, such as blood loss volume greater than 500 mL and open surgery, were significantly associated with stoma complications. Additionally, stoma features like location, shape, color, height, and edema were important factors in the association with complications. Body mass index over 30 kg/m² was also found to be a significant risk factor.

CONCLUSION

These findings highlight the need for a holistic approach to preventing and managing stoma complications, considering both patient-related and surgical factors.

Keywords: Stoma; Complication; Colorectal; Registry; Prospective

Core Tip: Among 734 colorectal cancer patients with stomas, 12.3% experienced stoma related complications, among which mucocutaneous separation, edema, and skin excoriation were the most common ones. The majority of complications were low grade (grade 1-2) by Clavien-Dindo classification. Key risk factors included surgical factors (blood loss > 500 mL, open surgery), stoma features (stoma location, shape, color, height and edema), and body mass index > 30 kg/m², emphasizing the need for comprehensive stoma management.