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临床试验/NCT06664762
NCT06664762已完成不适用

Left Lateral Position Versus Supine Position in Colonoscopy, a Multicenter Single-blind Randomized Clinical Trial Study

Hospital Civil de Guadalajara3 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年8月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
3
主要终点
Arrival time to the cecum

研究概览

简要总结

Currently, colonoscopy is a minimally invasive method that can be used as a diagnostic and therapeutic method by endoscopists, gastroenterologists and coloproctologists. Due to the importance and big impact this method has, it is necessary to both optimize its efficiency, and improve its quality, which is one of the main objectives of this protocol.

By observing which position its faster and which one also results in fewer complications when performing a colonoscopy without reducing its performance and following all the internationally established quality standards regarding colonoscoscopy.

The risk of this protocol implies a risk no greater than the minumum the procedure itself has, and does not generate extra cost for all of the patients subjected to this protocol.

详细描述

Currently, colonoscopy is one of the most used procedures when it comes to the study and treatment of patients with gastrointestinal conditions, including colorectal cancer, inflammatory bowel disease, etc.

In the area of colorectal neoplasia, colonoscopy has three main functions, which are to diagnose the desease itself and prevent its development by detecting and eliminating potentially premalignant lesions, as well as providing a diagnosis of cancer at an early stage.

The effectiveness of colonoscopy is crucial to carry out an accurate examination of the entire colorectal mucosa, which is why the quality of the procedure has been a subject of study in recent years. Among multiple factors that influence the quality of colonoscopies, the investigators can mention intestinal preparation, which is essential for an accurate procedure, because if patients have an inadequate preparation, it could impair the detection of lesions, since usually, in patients with little or no preparation, colonoscopy can be either incomplete, which requires the study to be repeated, or in case the study continues despite poor intestinal preparation, the presence of feces implies poor visualization of the colonic mucosa, which reduces the ability to detect lesions such as polyps, especially if they are <5 mm. Therefore, the type of solution and tolerability, the preparation regimen and the moment in which the intestinal preparation is performed are considerations to evaluate when performing a colonoscopy.

The position during the colonoscopy is another factor that can influence colonoscopy´s effectiveness, and also, the main focus for the investigators to study. Traditionally, if no position changes occur during colonoscopy, it begins and ends in the left lateral position. However, recent evidence suggests that supine position may reduce the disadvantages of the left lateral position, through decreased frequency of position changes and decreased abdominal pressure, which may result in an easier endoscope insertion in supine position when comparing it to left lateral position, however, there is very few information on the optimal insertion technique in colonoscopy, but it has been observed that in left lateral position, the air leaves the left colon causing it to collapse and also creating sharp curves that can be difficult to overcome during the procedure.

As previously mentioned, colonoscopy insertion is technically challenging, and one of the few clinical trials available that targeted the determination of optimal patient positioning during colonoscopy insertion compared the supine starting position with the left lateral starting position, and the investigators found that cecal intubation times decreased and patient comfort scores improved when using the supine position.

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
Single (Care Provider)

盲法说明

The main investigators will be in charge of randomizing all the patients ellegible for this protocol, and the care providers and endoscopists will be masked when it comes to knowing to which arm of the study each patient belongs to, untill the moment they need to perform the colonoscopy.

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients with indication for colonoscopy in our coloproctology service
  • •Both women and men
  • •Patients within an age range of 18-79 years
  • •Patients who agree having a colonoscopy and who sign the informed consent to participate in the protocol

排除标准

  • •Patients under 18 or over 80 years old
  • •All patients that won´t like to participate in the protocol or won´t sign the informed consent
  • •Pregnant women
  • •Patients with a medical record of colonic resection, ostomy status, severe cardiopulmonary and renal diseases, major psychiatric disorders, therapeutic colonoscopy or any contraindications for colonoscopy
  • •Non compliance with the colonic preparation regimen
  • •Active bleeding during the procedure
  • •Patients with a known diagnosis of colorectal cancer
  • •Patients with class III obesity
  • •Elimination criteria:
  • •Boston score <6 for colonic preparation
  • •Patients with a colonic lesion that makes it difficult to pass the colonoscope
  • •Patients with insufficient sedation that requires the procedure to stop temporarily
  • •Bowel perforation during colonoscopy
  • •Inability to reach the cecum despite loop reduction maneuvers
  • •Indication to suspend the study given by the anesthesiologist

研究组 & 干预措施

Left lateral position during colonoscopy

Active Comparator

干预措施: Left lateral position intervention (Behavioral)

Supine position during colonoscopy

Active Comparator

干预措施: Supine position intervention (Behavioral)

结局指标

主要结局

Arrival time to the cecum

时间窗: From date of randomization until the colonoscopy is done, assessed up to 9 months

ileocecal valve intubation time

时间窗: From date of randomization until the colonoscopy is done, assessed up to 9 months

次要结局

  • Percentage of ileocecal valve intubation(From date of randomization until the colonoscopy is done, assessed up to 9 months)
  • Adenoma detection rate(From date of randomization until the colonoscopy is done, assessed up to 9 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Roberto Ulises Cruz Neri

Principal investigator, Master in Science, Medical Staff in Coloproctology Department at Hospital Civil Fray Antonio Alcalde

Hospital Civil de Guadalajara

研究点 (3)

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