Wang Duan, Zhang Shengyu, Jiang Yinan, Ren Yutang, Kuai Dayu, Zhao Ruihong, Wu Dong
Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
Department of Gastroenterology, Peking Union Medical College Hospital, Dongcheng-qu, Beijing, China.
BMJ Open. 2024 Dec 2;14(12):e090606. doi: 10.1136/bmjopen-2024-090606.
Colonoscopy is widely used for screening and treatment of early colonic lesions and is critical for the early diagnosis of colorectal cancer. However, due to its invasive nature, colonoscopy can cause pain and discomfort for patients and is often associated with prolonged insertion times or failed attempts. Difficult colonoscopy is characterised by a caecal insertion time greater than 10 min, multiple insertion attempts or failed insertion, with an incidence rate of approximately 25%. Studies have shown that objective factors such as gender, age, body mass index, bowel preparation quality and history of abdominal or pelvic surgery can make colonoscopy difficult. Integrating clinical evidence and the established impact of personality traits on certain gastrointestinal conditions, a patient's personality traits and emotional and psychological states may also influence caecal insertion time during colonoscopy. Currently, no studies have investigated the predictive role of patients' personality on the difficulty of colonoscopy. This study used the Chinese-Language 44-Item Big Five Personality Inventory to assess patients' personality traits, aiming to observe whether there is a correlation between the degree of difficulty of colonoscopy and any of the personality traits.
This is a prospective, observational, multicentre study. Patients undergoing colonoscopy will be required to complete the Big Five Inventory, the General Anxiety Disorder 7-item scale and the Patient Health Questionnaire 9-item Depression Scale before colonoscopy. During the colonoscopy, the endoscopist will record the primary endpoint of caecal insertion time. The Boston Bowel Preparation Scale, patients pain scores and willingness to undergo a subsequent colonoscopy will be recorded as the secondary endpoints. The study plans to enrol a total of 322 patients. Survival analysis will be used to examine the correlation between colonoscopy difficulty and the Big Five personality traits.
This study was approved by the Ethics Committee of the Peking Union Medical College Hospital (No. K2128). All participants in this study will provide written informed consent. The results of this study will be published in an open-access way. There is no independent data monitoring committee because this is an observational and low-risk study.
NCT05584423.
结肠镜检查广泛应用于早期结肠病变的筛查和治疗,对结直肠癌的早期诊断至关重要。然而,由于其侵入性,结肠镜检查会给患者带来疼痛和不适,且常伴有插入时间延长或检查失败。困难结肠镜检查的特征是盲肠插入时间超过10分钟、多次插入尝试或插入失败,发生率约为25%。研究表明,性别、年龄、体重指数、肠道准备质量以及腹部或盆腔手术史等客观因素会使结肠镜检查变得困难。综合临床证据以及人格特质对某些胃肠道疾病的既定影响,患者的人格特质以及情绪和心理状态也可能影响结肠镜检查时的盲肠插入时间。目前,尚无研究调查患者人格对结肠镜检查难度的预测作用。本研究使用中文版44项大五人格量表评估患者的人格特质,旨在观察结肠镜检查的难度程度与任何一种人格特质之间是否存在相关性。
这是一项前瞻性、观察性、多中心研究。接受结肠镜检查的患者将被要求在结肠镜检查前完成大五人格量表、广泛性焦虑障碍7项量表和患者健康问卷9项抑郁量表。在结肠镜检查过程中,内镜医师将记录盲肠插入时间这一主要终点。波士顿肠道准备量表、患者疼痛评分以及接受后续结肠镜检查的意愿将被记录为次要终点。该研究计划共招募322名患者。生存分析将用于检验结肠镜检查难度与大五人格特质之间的相关性。
本研究已获得北京协和医院伦理委员会批准(编号:K2128)。本研究的所有参与者将提供书面知情同意书。本研究结果将以开放获取的方式发表。由于这是一项观察性低风险研究,因此没有独立的数据监测委员会。
NCT05584423。