Prospective RCT of Water exchange (WE) vs. WE plus Cap-Assisted Colonoscopy

水交换 (WE) 与 WE 加帽辅助结肠镜检查的前瞻性随机对照试验

• 批准号: 10710222
• 负责人: FELIX W LEUNG
• 金额: --
• 依托单位: VA GREATER LOS ANGELES HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-04-01 至 2022-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10710222
• 关键词: Address; Adopted; Affect; Agreement; Air; Carbon Dioxide; Characteristics; Clinic; Code; Colon; Colon Carcinoma; Colonoscopy; Consent; Control Groups; Critiques; Data; Data Analyses; Data Security; Detection; Development; Diagnosis; Disadvantaged; Eligibility Determination; Endoscopes; Enrollment; Ensure; Equilibrium; Equipment; Evaluable Disease; Female; Gender; Goals; Health; Immersion; Infusion procedures; Insufflation; Intubation; Linear Regressions; Logistic Regressions; Malignant Neoplasms; Methods; Modeling; Outcome; Pain; Patients; Performance; Phase; Polypectomy; Procedures; Questionnaires; Randomized; Randomized, Controlled Trials; Recovery; Reporting; Research; Research Personnel; Risk; Sample Size; Sampling; Schedule; Security Measures; Sedation procedure; Side; Site; Stratification Factors; Students; Techniques; Testing; Time; Update; Veterans; Water; Women' s Health; adenoma; adverse event monitoring; arm; awake; blocking factor; cancer prevention; cohort; colon cancer prevention; colorectal cancer screening; computer generated; cooperative study; data management; design; effective intervention; experience; human subject protection; improved; male; meetings; minimally invasive; pain reduction; preference; primary endpoint; prospective; recruit; screening policy; secondary outcome; success; trend

Sedation precludes ~10% of Veterans from colonoscopy due to no escorts. They accept scheduled unsedated colonoscopy. The option effectively manages no shows due to no escort. Other Veterans prefer no sedation. Insertion water exchange (WE) is significantly less painful than air insufflation. The addition of cap-assisted colonoscopy (WECAC) further reduces pain warrants confirmation. Colonoscopists with variable experience will assess generalizability of WECAC vs. WE. Both male and female Veterans will be recruited. Primary Hypothesis: Real-time maximum insertion pain (RTMIP) is significantly lower in the Veterans examined by WECAC vs. WE. Secondary Hypotheses: WECAC produces significantly higher quality colonoscopy outcomes in both male and female Veterans. Exploratory hypotheses: Co-variables affect Veterans' report of RTMIP. Method: Consenting Veterans will be randomized (computer generated random numbers in permuted block design with variable block sizes of 4 and 6), with code revealed at insertion of the endoscope. Gender will be a stratification factor. The investigators will be a blocking factor for the randomization to obtain treatment balance across investigators, however in the analytical phase the data from these investigators will be combined to assess the primary endpoint. Consent covers agreement to be randomized, respond to questionnaires, and allow recording of the examination for analysis, all in a de-identified fashion. State-of-the-art endoscopic equipment is in place. The investigators and support staff have extensive experience in both techniques. To ensure quality performance, both study and control groups are expected to maintain successful cecal intubation rate >95%. Applicable data management, human subject protection, adverse event monitoring and data security measures will be used. Sample size determination. Pilot data by 4 VA investigators in scheduled unsedated male Veterans were updated. The real time maximum insertion pain (RTMIP) [mean (SD)] was 2.7 (2.2) with WE (n=87) and 1.5 (2.1) with WECAC (n=38). The reduction (44%) 2.7-1.5=1.2 is 1.2/2.2=0.55 standard deviation (SD) units. The sample size/group needed to detect a difference at a level of significance of 0.0492 (adjusted for Obrien-Fleming interim stopping rules, one interim analysis at 50% completion) with 90% power is 72 or 144 total using a two-sided two sample t-test. Assuming 90% of subjects will be evaluable, we plan to recruit 160 male Veterans. For the male Veterans, over a 51 month period, 260 will be eligible and approached by research coordinators; 160 (80/arm) will be recruited. After receipt of the critique, the PI identified 9 scheduled unsedated female Veterans (5 WE, 4 WECAC). RTMIP were WE, 6.2 (3.5) and WECAC, 3.5 (3.7). The reduction (44%) was 2.7/3.7 or 0.7 SD unit. The female Veterans had higher RTMIP than the male Veterans, but the percent reduction (both 44%) of RTMIP by WECAC was equivalent. The sample size/group needed to detect a difference at a level of significance of 0.0492 (adjusted for Obrien-Fleming interim stopping rules, one interim analysis at 50% completion) with 90% power is 43 or 86 total using a two- sided two sample t-test. Assuming 90% of subjects will be evaluable, we plan to recruit 96 female Veterans. For the female Veterans, over a 51 month period, 184 to 191 will be eligible and approached by research coordinators; 96 (48/arm) will be recruited. At each VA site, the Women's Health clinic will assist the research coordinator to inform all female Veterans of the availability of the scheduled unsedated option. Data analysis: Prospective data will be analyzed by Fisher exact, χ2, Student t, linear or logistic regression, nonparametric methods and hierarchical model as indicated. Interim analysis will be performed to assess significant efficacy. Significance: Meeting patient unmet needs and preference. Long term goal: To address adenoma detection and interval cancer prevention in unsedated Veterans with the least painful insertion technique.

由于没有护送，镇静使大约10%的退伍军人无法进行结肠镜检查。他们接受预定的 未用镇静剂的结肠镜检查。由于没有护送，该选项有效地管理了没有演出。其他退伍军人更喜欢 没有镇静剂。插入水交换(WE)比空气充气的痛苦要小得多。增加了 帽子辅助结肠镜检查(WECAC)进一步减轻了疼痛，证实了这一点。结肠镜检查员 不同的经验将评估WECAC与WE的概括性。男性和女性退伍军人都将成为 被招募了。基本假设：实时最大插入痛(RTMIP)显著低于 退伍军人由WECAC VS WE检查。第二个假设：WECAC的产量显著高于 男性和女性退伍军人的高质量结肠镜检查结果。探索性假设：协变量 影响退伍军人RTMIP报告。方法：同意退伍军人将被随机(计算机生成 排列区块设计中的随机数，可变区块大小为4和6)，代码显示在 插入内窥镜。性别将成为一个分层因素。调查人员将成为一个阻碍因素 对于随机化以获得研究人员之间的治疗平衡，然而在分析阶段 来自这些调查人员的数据将被结合起来评估主要终点。同意包括协议 随机化，回答问卷，并允许记录检查以供分析，所有这些都在 不确定的时尚。最先进的内窥镜设备已经就位。调查人员和支持人员 在这两种技术方面都有丰富的经验。为了确保质量绩效，研究和控制都是 预计各组盲肠插管率将保持在95%。适用的数据管理， 将使用人体主体保护、不良事件监测和数据安全措施。样本量 决心。更新了4名退伍军人研究人员在未服用镇静剂的男性退伍军人中的飞行员数据。这个 实时最大插入痛(RTMIP)[平均值(SD)]：WE组为2.7(2.2)分，WE组为1.5(2.1)分 WECAC(n=38)。减少(44%)2.7-1.5=1.2是1.2/2.2=0.55标准差(SD)单位。样本 规模/组需要在0.0492的显著水平上检测差异(根据Obrien-Fleming进行调整 临时停止规则，50%完成时的一次临时分析)使用90%的功率为72或144 双侧双样本t检验。假设90%的受试者是可评估的，我们计划招募160名男性 退伍军人。对于男性退伍军人，在51个月的时间里，将有260人符合条件，并通过研究进行接触 协调员；将征聘160人(80人/ARM)。在收到批评意见后，PI确定了9个计划 未服用镇静剂的女性退伍军人(5名WE，4名WECAC)。RTMIP分别为WE 6.2(3.5)和WECAC 3.5(3.7)。这个 下降率(44%)为2.7/3.7或0.7 SD单位。女性退伍军人的RTMIP高于男性 退伍军人，但WECAC减少RTMIP的百分比(均为44%)相同。样本 规模/组需要在0.0492的显著水平上检测差异(根据Obrien-Fleming进行调整 临时停止规则，50%完成时的一个临时分析)使用两个- 双样本t检验。假设90%的受试者是可评估的，我们计划招募96名女性退伍军人。 对于女性退伍军人，在51个月的时间里，将有184到191人符合条件，并通过研究进行接触 协调员；将征聘96名协调员(48名/ARM)。在每个退伍军人事务部，妇女健康诊所将协助 研究协调员通知所有女性退伍军人可使用预定的非镇静剂选项。 数据分析：前瞻性数据分析采用FISHER EXCECT、χ2、t检验、线性或Logistic回归分析。 非参数方法和层次化模型。将执行中期分析以评估 疗效显著。意义：满足患者未满足的需求和偏好。长期目标：解决 未服用镇静剂的退伍军人的腺瘤检测和间歇性癌症预防 技术。