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临床试验/NCT01320826
NCT01320826已完成不适用

Prospective Study of the Quality of Colonoscopies Performed by Primary Care Endoscopists in Alberta, Canada

University of Alberta13 个研究点 分布在 1 个国家目标入组 577 人开始时间: 2010年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
577
试验地点
13
主要终点
Percentage of Successful Cecal Intubations (Crude)

研究概览

简要总结

It is hypothesized that primary care colonoscopists are able to achieve benchmarks in colonoscopy quality including cecal intubation and adenoma detection rates and serious adverse event rates.

This prospective study is the first in depth analysis of the quality of colonoscopic procedures performed by primary care physicians at a provincial level in Canada.

In addition, the APC Endo study is the first to directly examine both the quality of colonoscopy and patient satisfaction in the same study.

详细描述

Discrepant data exists about the quality of colonoscopies performed by family physicians and general internists. Currently in Canada, gastroenterologists and general surgeons perform 97% of the colonoscopies, but excessive wait times highlight a shortage of colonoscopists in Canada. This shortage will invariably worsen as our population ages and more Canadians become screened for colorectal cancer.

One method of improving this relative shortage of colonoscopists is through training primary care physicians in GI medicine and endoscopy. In order these physicians to be a legitimate option in the provision of colonoscopies; however, it must be shown that, as a group, they are able to meet benchmarks in colonoscopy competency.

This multi-centre observational study will be the first study to prospectively analyze colonoscopic examinations performed by primary care physicians at a provincial level. Using primarily cecal intubation rates and adenoma detection rates, along with other quality parameters, this study will compare the results of Alberta primary care physicians to standard benchmarks in colonoscopy competency.

Data will be collected using case report forms completed at the time of the colonoscopy, reviewing the patients' colonoscopy pathology results and a post procedure telephone survey to examine patient satisfaction rates.

If this study demonstrates that quality benchmarks are indeed met, then future training of primary care physicians in gastrointestinal medicine and endoscopy would be encouraged to help address current and future colonoscopist shortages.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • All patients having a colonoscopy done by an APC-Endo physician endoscopist during the study period will be approached at the time of their endoscopy to consent to the post procedure telephone.

排除标准

  • Patients under the age of 18 years old
  • Patients who will be unable to be contacted for the post procedure telephone survey. (e.g., moving out of the country in the following month)
  • Patients who are unable to understand or speak basic English
  • Patients who are cognitively impaired such that they were not able to complete the initial consent for their colonoscopy

结局指标

主要结局

Percentage of Successful Cecal Intubations (Crude)

时间窗: At time of colonoscopy (DAY 1 of study)

The percentage of successful cecal intubations (crude) = (total # of colonoscopies performed where cecal intubation was achieved / total # of colonoscopies attempted) x 100

Percentage of Successful Cecal Intubations (Adjusted)

时间窗: At time of colonoscopy (DAY 1 of study)

The percentage of successful cecal intubations (adjusted) = total number of colonoscopies performed where cecal intubation was achieved / (total number of colonoscopies attempted -incomplete colonoscopies due to poor bowel preparation, colonic stricture, equipment failure or severe endoscopic colitis)

Adenoma Detection Ratio

时间窗: When pathology from colonoscopy available (on average 2-3 weeks after procedure)

The adenoma detection ratio is the number of pathologically verified adenomas per number of colonoscopies performed. Adenoma detection ratio = total number of pathologically confirmed adenomas / number of colonoscopies attempted.

Percentage of Males 50 Years and Older Undergoing First Time Colonoscopy With an Adenoma

时间窗: When pathology from colonoscopy available (on average 2-3 weeks after procedure)

Percentage of patients with an adenoma = (number of patients who had at least one adenoma detected on colonoscopy / total number of colonoscopies attempted) x 100. For this specific outcome: we explored this outcome for males 50 years and older undergoing first time colonoscopy.

Percentage of Females 50 Years and Older Undergoing First Time Colonoscopy With an Adenoma

时间窗: [When pathology from colonoscopy available (on average 2-3 weeks after procedure)]

Percentage of patients with an adenoma = (number of patients who had at least one adenoma detected on colonoscopy / total number of colonoscopies attempted) x 100. For this specific outcome: we explored this outcome for females 50 years and older undergoing first time colonoscopy.

次要结局

  • Colonoscopy Complications: Bleeding, Perforation, Cardiopulmonary Complications Secondary to Conscious Sedation, and Death.(Within four (4) weeks of colonoscopy)
  • Colonoscopy Withdraw Time in Cases Where no Lesions Found(At time of colonoscopy (DAY 1 of study))
  • Patient Comfort During Colonoscopy(At time of colonoscopy (DAY 1 of study))
  • Patient Satisfaction With Endoscopy Wait Time(At patient satisfaction phone survey (on average 4 weeks after colonoscopy))
  • Patient Satisfaction With Hospital Experience for Colonoscopy(At patient satisfaction phone survey (on average 4 weeks after colonoscopy))
  • Colonoscopy Procedure Time(At time of colonoscopy (DAY 1 of study))
  • Percentage of Patients Referred to a Specialist.(Within four (4) weeks of colonoscopy)

研究者

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

Brian Rowe

Associate Dean (Clinical Research), Faculty of Medicine and Dentistry Canada Research Chair in Emergency Airway Diseases Professor and Research Director Department of Emergency Medicine, University of Alberta

University of Alberta

研究点 (13)

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