Water Exchange Colonoscopy in Elderly Patients
Water Exchange Colonoscopy in Elderly Patients: A Prospective Randomized Controlled Trial
Colonoscopy is an important test for detecting colorectal polyps and cancer, but it can cause pain and discomfort, especially in older adults. Traditional colonoscopy uses air to expand the colon. Water exchange colonoscopy uses warm water instead of air, which may reduce pain and make the examination easier. This study compared four colonoscopy methods in patients aged 55 years and older: non-anesthesia water injection, non-anesthesia gas insufflation, anesthesia water injection, and anesthesia gas insufflation. Two hundred participants were randomly assigned to one of the four groups. The study measured pain using a visual analog scale, the time needed to reach the cecum, and blood levels of inflammatory markers (IL-1β, IL-6, and PGE2). The results may help doctors choose a safer and more comfortable colonoscopy method for older patients, especially when anesthesia may not be suitable.
Обзор исследования
Статус
Подробное описание
Background: Colorectal cancer incidence and mortality increase with age, and colonoscopy is essential for screening and managing colorectal polyps. Conventional gas insufflation can cause abdominal distension, pain, and loop formation, particularly in elderly patients who often have relaxed abdominal muscles, elongated colons, and comorbidities that increase anesthesia risk. Water exchange colonoscopy has been reported to reduce pain by using warm water to navigate the colon without full gas distension.
Objective: To evaluate the clinical value of non-anesthesia water exchange colonoscopy in elderly patients and compare it with anesthesia water exchange, non-anesthesia gas insufflation, and anesthesia gas insufflation.
Methods: This was a single-center, prospective, randomized controlled trial that enrolled 200 patients aged 55 years or older undergoing colonoscopy between November 2024 and December 2025. Participants were randomly assigned (1:1:1:1) using a random number table to four groups (n=50 each): non-anesthesia water injection (NW), non-anesthesia gas insufflation (NA), anesthesia water injection (AW), and anesthesia gas insufflation (AA). All procedures were performed by an experienced endoscopist using a high-definition colonoscope (Olympus CF-HQ290I). Bowel preparation used standard polyethylene glycol electrolyte powder. In water injection groups, warm water at 37°C was injected through the biopsy channel during insertion, with suction of gas and fluid as needed. In gas insufflation groups, conventional air insufflation was used. Anesthesia groups received intravenous propofol combined with a small amount of opioid, administered by an anesthesiologist with continuous vital sign monitoring. The non-anesthesia groups received no anesthesia or analgesia.
Outcomes: The primary outcomes included maximum pain score during examination measured by a 10-point visual analog scale (VAS), cecal intubation time (minutes from insertion to identification of the ileocecal landmark), and serum levels of inflammatory and pain mediators (IL-1β, IL-6, and PGE2) measured by ELISA before and during colonoscopy. Non-inferiority of AW versus NW was assessed for inflammatory mediator inhibition using pre-specified margins. Statistical analysis used SPSS 25.0, with one-way ANOVA, Tukey HSD test, chi-square test, and non-inferiority testing; P<0.05 was considered statistically significant.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Zhejiang
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Hangzhou, Zhejiang, Китай, 311300
- Department of Colorectal Surgery, The First People's Hospital of Lin'an District, Hangzhou
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Age ≥ 55 years
- Indications for colonoscopy
- Signed informed consent form
Exclusion Criteria:
- History of intestinal surgery
- Severe intestinal stenosis or obstruction
- Cognitive impairment that precludes cooperation with assessment
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Скрининг
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Non-anesthesia water injection (NW)
Participants receive water exchange colonoscopy without anesthesia. Warm water at 37°C is injected through the biopsy channel during insertion; gas and fluid are aspirated as needed. No anesthesia or analgesia is administered. |
During endoscope insertion, warm water at 37°C is injected through the biopsy channel to facilitate the procedure. Gas and liquid within the cavity are aspirated as thoroughly as possible. A minimal amount of gas is introduced for observation when necessary.
Другие имена:
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Экспериментальный: Non-anesthesia gas insufflation (NA)
Participants receive conventional gas insufflation colonoscopy without anesthesia. Air is used to expand the intestinal lumen. No anesthesia or analgesia is administered. |
Conventional air insufflation is employed to expand the intestinal lumen, thereby aiding in endoscope insertion.
Другие имена:
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Экспериментальный: Anesthesia water injection (AW)
Participants receive water exchange colonoscopy under intravenous general anesthesia with propofol and a small quantity of opioid drugs, administered by an anesthesiologist with continuous vital sign monitoring. |
During endoscope insertion, warm water at 37°C is injected through the biopsy channel to facilitate the procedure. Gas and liquid within the cavity are aspirated as thoroughly as possible. A minimal amount of gas is introduced for observation when necessary.
Другие имена:
Intravenous general anesthesia consisting of propofol combined with a small quantity of opioid drugs, administered by an anesthesiologist prior to the examination, with continuous monitoring of vital signs.
Другие имена:
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Экспериментальный: Anesthesia gas insufflation (AA)
Participants receive conventional gas insufflation colonoscopy under intravenous general anesthesia with propofol and a small quantity of opioid drugs, administered by an anesthesiologist with continuous vital sign monitoring. |
Conventional air insufflation is employed to expand the intestinal lumen, thereby aiding in endoscope insertion.
Другие имена:
Intravenous general anesthesia consisting of propofol combined with a small quantity of opioid drugs, administered by an anesthesiologist prior to the examination, with continuous monitoring of vital signs.
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Serum inflammatory factors and pain mediators
Временное ограничение: Baseline and periprocedural
|
Change from baseline in serum levels of interleukin-1β (IL-1β), interleukin-6 (IL-6), and prostaglandin E2 (PGE2) measured by ELISA before and during colonoscopy. Used for non-inferiority comparison between non-anesthesia water injection (NW) and anesthesia water injection (AW). |
Baseline and periprocedural
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Pain score (VAS)
Временное ограничение: Periprocedural
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Maximum pain level during colonoscopy assessed by the patient using a visual analog scale (VAS, 0-10 points, where 0 indicates no pain and 10 signifies severe pain). |
Periprocedural
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Cecal intubation time
Временное ограничение: Periprocedural
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Duration from colonoscope insertion to reaching the ileocecal area and identifying the cecal landmark (e.g., appendiceal orifice or ileocecal valve), recorded in minutes. |
Periprocedural
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Adverse events
Временное ограничение: Periprocedural
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Incidence of procedure-related adverse events, including abdominal distension, pain, intestinal perforation, respiratory depression, cardiovascular events, and allergic reactions. |
Periprocedural
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Соавторы и исследователи
Следователи
- Главный следователь: Yongjian Liao, MD, First People's Hospital of Hangzhou
Публикации и полезные ссылки
Общие публикации
- He KQ, Huang TT, Tan MY, Gao C, Wang S. Efficacy and Safety of Ciprofol Versus Propofol as Anesthetic for Patients Undergoing Painless Colonoscopy. Pain Ther. 2024 Dec;13(6):1633-1644. doi: 10.1007/s40122-024-00662-x. Epub 2024 Oct 14.
- Xu X, Ni D, Lu Y, Huang X. Diagnostic application of water exchange colonoscopy: A meta-analysis of randomized controlled trials. J Int Med Res. 2019 Feb;47(2):515-527. doi: 10.1177/0300060518819626. Epub 2019 Jan 11.
- Cadoni S, Ishaq S, Hassan C, Falt P, Fuccio L, Siau K, Leung JW, Anderson J, Binmoeller KF, Radaelli F, Rutter MD, Sugimoto S, Muhammad H, Bhandari P, Draganov PV, de Groen P, Wang AY, Yen AW, Hamerski C, Thorlacius H, Neumann H, Ramirez F, Mulder CJJ, Albeniz E, Amato A, Arai M, Bak A, Barret M, Bayupurnama P, Cheung R, Ching HL, Cohen H, Dolwani S, Friedland S, Harada H, Hsieh YH, Hayee B, Kuwai T, Lorenzo-Zuniga V, Liggi M, Mizukami T, Mura D, Nylander D, Olafsson S, Paggi S, Pan Y, Parra-Blanco A, Ransford R, Rodriguez-Sanchez J, Senturk H, Suzuki N, Tseng CW, Uchima H, Uedo N, Leung FW. Water-assisted colonoscopy: an international modified Delphi review on definitions and practice recommendations. Gastrointest Endosc. 2021 Jun;93(6):1411-1420.e18. doi: 10.1016/j.gie.2020.10.011. Epub 2020 Oct 16.
- Ding Y, Lin X. Outcomes and safety of colonoscopy in elderly patients aged 80 years and older: a retrospective cohort study. PeerJ. 2025 Nov 19;13:e20404. doi: 10.7717/peerj.20404. eCollection 2025.
- Singal AG, Gupta S, Skinner CS, Ahn C, Santini NO, Agrawal D, Mayorga CA, Murphy C, Tiro JA, McCallister K, Sanders JM, Bishop WP, Loewen AC, Halm EA. Effect of Colonoscopy Outreach vs Fecal Immunochemical Test Outreach on Colorectal Cancer Screening Completion: A Randomized Clinical Trial. JAMA. 2017 Sep 5;318(9):806-815. doi: 10.1001/jama.2017.11389.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- LY2024013K
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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