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: 10683057
• 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/10683057
• 关键词: Address; Adopted; Affect; Agreement; Air; Carbon Dioxide; Cecum; Characteristics; Clinic; Code; Colon; Colon Carcinoma; Colonoscopy; Consent; Control Groups; Critiques; Data; Data Analyses; Data Security; Detection; Development; Diagnosis; Disadvantaged; 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; 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.

由于没有陪同人员，镇静剂使约10%的退伍军人无法进行结肠镜检查。他们接受预定的 非镇静剂结肠镜检查该选项有效地管理没有显示，由于没有护送。其他退伍军人更喜欢 没有镇静剂。插入水交换（WE）比空气注入疼痛明显更少。添加 帽辅助结肠镜检查（WECAC）进一步减少疼痛值得确认。结肠镜检查者， 不同的经验将评估WECAC与WE的普遍性。男性和女性退伍军人将 招募的主要假设：实时最大插入疼痛（RTMIP）在 退伍军人检查WECAC与我们。次要假设：WECAC产生显著更高的 男性和女性退伍军人的结肠镜检查结果。探索性假设：协变量 影响退伍军人的RTMIP报告。方法：将随机分配退伍军人（计算机生成 排列区组设计中的随机数，区组大小为4和6），代码显示在 插入内窥镜。性别将是一个分层因素。调查人员将是一个阻碍因素 对于随机化，以获得研究者之间的治疗平衡，但是在分析阶段， 这些研究者的数据将被合并以评估主要终点。同意涵盖协议 进行随机化，回答问卷，并允许记录检查进行分析，所有这些都在一个 去身份化的时尚最先进的内窥镜设备已经到位。调查人员和支助人员 在这两种技术上都有丰富的经验。为了确保质量性能，研究和控制 预计各组盲肠插管成功率保持> 95%。适用的数据管理， 将采用人类受试者保护、不良事件监测和数据安全措施。样本量 保持战略定力更新了4名VA研究者在计划的未镇静男性退伍军人中的初步数据。的 真实的时间最大插入疼痛（RTMIP）[平均值（SD）]为2.7（2.2），WE组（n=87）和1.5（2.1）， WECAC（n=38）。减少（44%）2.7-1.5=1.2为1.2/2.2=0.55标准差（SD）单位。样品 在0.0492的显著性水平下检测差异所需的样本量/组（针对Obrien-Fleming进行调整 中期停止规则，在50%完成时进行一次中期分析），把握度为90%，使用 双侧双样本t检验。假设90%的受试者可评价，我们计划招募160名男性 老兵对于男性退伍军人，在51个月的时间内，260人将有资格通过研究接触 协调员;将征聘160名（80名/组）。收到批评后，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）。的 减少（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的RTMIP降低百分比（均为44%）是相等的。样品 在0.0492的显著性水平下检测差异所需的样本量/组（针对Obrien-Fleming进行调整 中期停止规则，在50%完成时进行一次中期分析），把握度为90%，使用两个- 双侧样本t检验假设90%的受试者可评估，我们计划招募96名女性退伍军人。 对于女性退伍军人，在51个月的时间内，184至191人将有资格通过研究接触 协调员;将征聘96名（每组48名）。在每个VA站点，妇女健康诊所将协助 研究协调员通知所有女性退伍军人的可用性预定的非镇静剂选项。 数据分析：前瞻性数据将通过Fisher精确、χ2、Student t、线性或逻辑回归进行分析， 非参数方法和分层模型。将进行中期分析，以评估 显著功效。意义：满足患者未满足的需求和偏好。长期目标：解决 在未使用镇静剂的退伍军人中以最小疼痛插入进行腺瘤检测和间隔癌症预防 法