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临床试验/NCT07830823
NCT07830823已完成不适用

Water Exchange Colonoscopy in Elderly Patients: A Prospective Randomized Controlled Trial

First People's Hospital Of Lin'an District, Hangzhou1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
Serum inflammatory factors and pain mediators

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
55 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 55 years
  • Indications for colonoscopy
  • Signed informed consent form

排除标准

  • History of intestinal surgery
  • Severe intestinal stenosis or obstruction
  • Cognitive impairment that precludes cooperation with assessment

研究组 & 干预措施

Non-anesthesia water injection (NW)

Experimental

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.

干预措施: Water exchange colonoscopy (Procedure)

Non-anesthesia gas insufflation (NA)

Experimental

Participants receive conventional gas insufflation colonoscopy without anesthesia. Air is used to expand the intestinal lumen. No anesthesia or analgesia is administered.

干预措施: Gas insufflation colonoscopy (Procedure)

Anesthesia water injection (AW)

Experimental

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.

干预措施: Water exchange colonoscopy (Procedure)

Anesthesia water injection (AW)

Experimental

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.

干预措施: Propofol and opioid anesthesia (Drug)

Anesthesia gas insufflation (AA)

Experimental

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.

干预措施: Gas insufflation colonoscopy (Procedure)

Anesthesia gas insufflation (AA)

Experimental

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.

干预措施: Propofol and opioid anesthesia (Drug)

结局指标

主要结局

Serum inflammatory factors and pain mediators

时间窗: 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).

Pain score (VAS)

时间窗: Periprocedural

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).

次要结局

  • Cecal intubation time(Periprocedural)
  • Adverse events(Periprocedural)

研究者

发起方
First People's Hospital Of Lin'an District, Hangzhou
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yongjian Liao

First People's Hospital Of Lin'an District, Hangzhou

First People's Hospital Of Lin'an District, Hangzhou

研究点 (1)

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