一次性先端帽辅助结肠镜检查的随机对照研究

A randomized controlled study on disposable distal attachment‑assisted colonoscopy

摘要:

目的 评估新型一次性先端帽在结肠镜检查中的可行性。方法 采用随机对照设计，前瞻性连续纳入2024年6月至12月期间在保定市第一中心医院内镜诊疗中心就诊且符合入选标准的受试者，通过密封信封法随机分为试验组（使用一次性先端帽）和对照组（常规结肠镜检查）。比较两组的息肉检出数量和检出率、腺瘤检出数量和检出率以及病灶形态学特征。结果 共纳入415例患者，试验组207例，对照组208例，两组受试者基线资料差异无统计学意义（P>0.05）。试验组息肉检出率［68.9%（142/207）比57.7%（120/208），χ2=5.30，P=0.021］和腺瘤检出率［50.7%（105/207）比40.9%（85/208），χ2=4.06，P=0.044］均高于对照组。试验组每例次肠镜的息肉检出数量［（2.07±2.91）个比（1.39±2.07）个，t=2.71，P=0.007］和每例次肠镜的腺瘤检出数量［（1.57±2.83）个比（1.06±1.68）个，t=2.22，P=0.027］显著高于对照组。试验组的微小息肉检出率显著高于对照组［61.4%（127/207）比50.5%（105/208），χ2=4.98，P=0.026］。试验组山田Ⅰ型［49.3%（102/207）比 39.4%（82/208），χ2=4.08，P=0.043］和山田Ⅱ型息肉［38.2%（79/207）比23.6%（49/208），χ2=10.38，P=0.001］的检出率显著高于对照组。两组均未发生出血、穿孔等不良事件。结论 一次性先端帽可显著提高结肠镜检查息肉和腺瘤的检出数量及检出率，同时更容易检出微小息肉、山田Ⅰ型、山田Ⅱ型息肉，具有临床推广价值。

Abstract:

Objective To evaluate the feasibility of a novel disposable distal attachment in colonoscopy. Methods This randomized controlled study prospectively enrolled all consecutive eligible subjects undergoing colonoscopy at the Endoscopic Diagnosis and Treatment Center, Baoding No. 1 Central Hospital from June to December 2024. Subjects were allocated via sealed-envelope randomization into the test group (with disposable distal attachment) or the control group (standard colonoscopy). Polyp detection count and detection rate, adenoma detection count and detection rate, and morphological characteristics of lesions were compared between the two groups. Results Among 415 patients (test group: n=207, control group: n=208), baseline characteristics were comparable (P>0.05). The test group demonstrated statistically significant superiority in both polyp detection rate [68.9% (142/207) VS 57.7% (120/208), χ2=5.30, P=0.021] and adenoma detection rate [50.7% (105/207) VS 40.9% (85/208), χ2=4.06, P=0.044]. The test group also demonstrated significantly higher polyp yield per procedure (2.07±2.91) compared with the control group (1.39±2.07), with significant difference (t=2.71, P=0.007); similarly, adenoma yield per procedure was significantly greater in the test group (1.57±2.83) versus the control group (1.06±1.68, t=2.22, P=0.027). The test group demonstrated significantly higher detection rates for diminutive polyps [61.4% (127/207) VS 50.5% (105/208), χ²=4.98, P=0.026], Yamada type Ⅰ polyps [49.3% (102/207) VS 39.4% (82/208), χ²=4.08, P=0.043], and Yamada type Ⅱ polyps [38.2% (79/207) VS 23.6% (49/208), χ²=10.38, P=0.001] compared with the control group. No procedure-related adverse events such as bleeding or perforation occurred in either group. Conclusion The disposable distal attachment significantly improves polyp and adenoma detection during colonoscopy, particularly for diminutive, Yamada type Ⅰ, and type Ⅱ polyps, demonstrating substantial clinical utility.