Modified pull-through procedure versus coloanal anastomosis with temporary stoma for low/ultra-low rectal cancer following preoperative chemoradiotherapy: protocol for a multicentre randomised controlled trial.
무작위 임상시험
1/5 보강
PICO 자동 추출 (휴리스틱, conf 2/4)
유사 논문P · Population 대상 환자/모집단
216 patients with low rectal cancer (≤7 cm from the anal verge) after preoperative CRT will be enrolled and randomly assigned (1:1) to undergo either the modified pull-through procedure or CAA with temporary stoma.
I · Intervention 중재 / 시술
추출되지 않음
C · Comparison 대조 / 비교
추출되지 않음
O · Outcome 결과 / 결론
Results will be disseminated via academic conferences and peer-reviewed journals to optimise clinical practice for low rectal cancer surgery. [TRIAL REGISTRATION NUMBER] ChiCTR2500100246.
[INTRODUCTION] Colorectal cancer (CRC) incidence is increasing, and treating low rectal cancer poses challenges in balancing oncological control with functional preservation.
APA
Li D, Du Z, et al. (2025). Modified pull-through procedure versus coloanal anastomosis with temporary stoma for low/ultra-low rectal cancer following preoperative chemoradiotherapy: protocol for a multicentre randomised controlled trial.. BMJ open, 15(12), e107385. https://doi.org/10.1136/bmjopen-2025-107385
MLA
Li D, et al.. "Modified pull-through procedure versus coloanal anastomosis with temporary stoma for low/ultra-low rectal cancer following preoperative chemoradiotherapy: protocol for a multicentre randomised controlled trial.." BMJ open, vol. 15, no. 12, 2025, pp. e107385.
PMID
41338645 ↗
Abstract 한글 요약
[INTRODUCTION] Colorectal cancer (CRC) incidence is increasing, and treating low rectal cancer poses challenges in balancing oncological control with functional preservation. While preoperative chemoradiotherapy (CRT) improves sphincter preservation, anastomotic leakage (AL) remains a major complication. This trial aims to compare the efficacy of modified pull-through procedure versus coloanal anastomosis (CAA) with temporary stoma in low rectal cancer patients following preoperative CRT.
[METHODS AND ANALYSIS] This is a multicentre, assessor-blinded, randomised controlled trial. A total of 216 patients with low rectal cancer (≤7 cm from the anal verge) after preoperative CRT will be enrolled and randomly assigned (1:1) to undergo either the modified pull-through procedure or CAA with temporary stoma. The primary outcome is the incidence of AL within 1 month. Secondary outcomes include complications (Clavien-Dindo classification), length of hospital stay, anorectal function (LARS score (Low Anterior Resection Syndrome Score)), and quality of life (EQ-5D questionnaire (EuroQol five dimensions questionnaire)). Patients will be followed for 36 months.
[ETHICS AND DISSEMINATION] The study has obtained ethics approval from the Biomedical Ethics Committee of West China Hospital, Sichuan University (ethics approval ID: 2025-Review-(144)). All centres have obtained local institutional review board approval. Results will be disseminated via academic conferences and peer-reviewed journals to optimise clinical practice for low rectal cancer surgery.
[TRIAL REGISTRATION NUMBER] ChiCTR2500100246.
[METHODS AND ANALYSIS] This is a multicentre, assessor-blinded, randomised controlled trial. A total of 216 patients with low rectal cancer (≤7 cm from the anal verge) after preoperative CRT will be enrolled and randomly assigned (1:1) to undergo either the modified pull-through procedure or CAA with temporary stoma. The primary outcome is the incidence of AL within 1 month. Secondary outcomes include complications (Clavien-Dindo classification), length of hospital stay, anorectal function (LARS score (Low Anterior Resection Syndrome Score)), and quality of life (EQ-5D questionnaire (EuroQol five dimensions questionnaire)). Patients will be followed for 36 months.
[ETHICS AND DISSEMINATION] The study has obtained ethics approval from the Biomedical Ethics Committee of West China Hospital, Sichuan University (ethics approval ID: 2025-Review-(144)). All centres have obtained local institutional review board approval. Results will be disseminated via academic conferences and peer-reviewed journals to optimise clinical practice for low rectal cancer surgery.
[TRIAL REGISTRATION NUMBER] ChiCTR2500100246.
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