Randomized Controlled Trial Comparing the Impact of Water Assisted Colonoscopy vs Air Insufflation on Resident Training
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Cecal Intubation Rate
研究概览
简要总结
This study will be a randomized trial comparing the use of only water or water and air insufflation during colonoscopy insertion by trainees. This study will be looking at the impact that water-assisted colonoscopy has on resident learning. The investigators hypothesize that the use of water only compared to water and air will improve the learning experience for trainees.
详细描述
In this trial, the investigators will offer participation in the study when patients present for their scheduled routine colonoscopy. The participants will be asked to give consent for the colonoscopy procedure and participation in the trial. After consent is obtained and information is taken from the participants, each participant would be randomly assigned to either water only or water and air insufflation on insertion via a computer-generated random number. All patients over the age of 18 presenting for their scheduled colonoscopy at either the Health Sciences Centre or St. Clare's Mercy Hospital in St. John's, Newfoundland, can participate in the study. The colonoscopy will then be done in the usual manner with appropriate sedation. Patients will then be debriefed regarding their colonoscopy following the procedure in recovery. At the completion of the data extraction above, all trainee participants will undergo a semi-structured exit interview with one of the study investigators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
The participant will be blinded to the intervention until after the pain score has been completed.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients over the age of 18 presenting for their scheduled routine colonoscopy at either the Health Sciences Center or St. Clare's Mercy Hospital in St. John's, NL, can participate in the study.
排除标准
- •Previous bowel resection, refusal to participate, inability to provide informed consent, known bowel obstruction, emergency colonoscopy. It will be noted if patients have had a previous hysterectomy, patient's age, BMI, gender, and quality of bowel preparation as these factors have been known to prolong cecal intubation.
结局指标
主要结局
Cecal Intubation Rate
时间窗: Cecal intubation rate with a 12-15 minute time limit before staff takes over
The percentage of success in which the trainee advances the colonoscope to the cecum.
次要结局
- Time to transverse colon intubation(Time from the start of the colonoscopy until the trainee reaches the transverse colon.)
- Semi-structured exit interview(After the data extraction (five minutes to complete))
- Rate of transverse colon intubation(Time from colonoscope insertion to transverse colon intubation.)
- Patient comfort(Recorded during the colonoscopy)
- Polyp/adenoma detection rate(This will occur after all the procedures have been completed. Will take roughly 1-2 days to record the number of polpys/adenomas detected.)
- Sedation dosage required(Duration of the colonoscopy)
- Complications during the procedure(Any complications that take place within the time frame of the procedure will be recorded.)
研究者
Maria MacDonald
Medical Student
Memorial University of Newfoundland