跳至主要内容
临床试验/NCT01434199
NCT01434199Unknown3 期

Does Endoscope Position Detecting Unit Facilitate Caecal Intubation? A Randomized Controlled Trial

Chinese University of Hong Kong2 个研究点 分布在 1 个国家目标入组 870 人开始时间: 2011年7月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
入组人数
870
试验地点
2
主要终点
caecal intubation rate

研究概览

简要总结

As the incidence of colorectal cancer (CRC) has been rapidly rising in Asian countries, more and more screening colonoscopies are now being performed for prevention or early detection of this fatal disease. Complete colonoscopy as indicated by caecal intubation is essential to make it a reliable screening tool for colorectal cancer or polyps. Cecal intubation rate is highly variable and dependent on individual experience. Colonic looping is the commonest cause of incomplete colonoscopy. Magnetic endoscope imaging (MEI) is a non-radiological imaging technique to provide real time, three-dimensional image and position of the colonoscope during the procedure. It may facilitate straightening of colonic loops and hence cecal intubation.

The investigators aim to evaluate the benefit of MEI in term of cecal intubation rate across endoscopists of all levels of experience by making use of the newly developed Endoscopy Position Detecting Unit (UPD-3)by Olympus Optical Co, Ltd, Japan.

The investigators propose to conduct a prospective randomized controlled trial to compare the caecal intubation rate of colonoscopy being performed with and without UPD-3 guidance. Colonoscopies performed by endoscopists with different level of experience will be randomized to UPD-3 guided group or conventional group (no UPD-3 guidance). Patient controlled sedation (PCS) containing propofol and alfentanil will be given to all patients. The investigators hypothesize that UPD-3 guided colonoscopy is associated with high caecal intubation rate (complete colonoscopy), shorter time to caecum, less patient pain and lower sedative medication requirement. A high caecal intubation rate facilitates a reliable colonoscopy screening. Decreased colonic looping and shorter time to caecum may reduce patient discomfort during the procedure. It may also facilitate learning and acquiring the skill of colonoscopy in trainees.

详细描述

Hypothesis UPD guided colonoscopy improves cecal intubation rate.

Methods

Trial design This is a prospective randomized controlled trial comparing the cecal intubation rate of colonoscopy being performed with and without UPD guidance by endoscopists of different levels of experience. The trial will be conducted in the Endoscopy Unit of a university affiliated hospital.

Patients who will have elective colonoscopy in the Endoscopy Unit during the study period, and meet the following inclusion criteria are recruited. The colonoscopy will be done by 6 dedicated endoscopists with different levels of experience in performing colonoscopy.

Interventions

研究设计

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

入排标准

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

入选标准

  • •Aged 18 years or above
  • •American Society of Anaesthesiologist (ASA) grading I-III
  • •Scheduled for elective colonoscopy

排除标准

  • •Previous colonic resection
  • •Refuse to consent to participate
  • •History of allergy to propofol or alfentanil
  • •Has a pacemaker in situ
  • •Pregnant lady

研究组 & 干预措施

UPD guided group

Experimental

Both the colonoscopist and assistant will be viewing the imager screen during the whole procedure.

干预措施: UPD guidance (Procedure)

non-UPD guided group

No Intervention

Conventional colonoscopy would be done without image guidance.

结局指标

主要结局

caecal intubation rate

时间窗: 10minutes in average after starting the procedure

Caeal intubation is the landmark for complete colonoscopy. Caecal intubation would be documented after each procedure. The caecal intubation rate with or without UPD guidance would be compared. The result would provide information whether the UPD device can faciliate complete colonoscopy.

次要结局

  • Caecal intubation time(10 minutes in average after starting the procedure)

研究者

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

Hon Sok Fei

Associate consultant

Chinese University of Hong Kong

研究点 (2)

Loading locations...

相似试验