Clinical trial NCT01762735: Water Injection Colonoscopy vs Air Insufflation Colonoscopy in Training the Beginners
Official title: Water Injection Colonoscopy vs Air Insufflation Colonoscopy in Training the Beginners
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Disease
Rectal Disease
Pain
Lead sponsor: First Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
First posted: 2013-01-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Water injection colonoscopy has been a generally accepted method in training the beginners of colonoscopy for its low pain and less cecal intubation time, we would conduct this study to investigate more advantages of this method and make most use of it for beginners' training.

Detailed description: Colonoscopy is the gold standard for diagnosing the large bowel diseases, caecum intubation is the success of the colonoscopy, although with the progress of the function and the technique, for most patients, when facing with inexperienced examiners, conventional air insufflation colonoscopy is still a painful experience. Despite of the application of the technique of abdomen compression, position change of the patients and the sedatives or analgesics, to master well of the colonoscopy for the first-learners still needs much practice.

Up to now, many studies has showed that compared with air insufflation colonoscopy, water-related colonoscopy could shorten the cecal intubation time and relieve the pain of the patients,especially for training the beginners，the effect was notable, but the present researches on water assisted technique has still been confined to following aspects:1.Water infusing was based on air insufflation; predetermined amount of water was infused ,and water was infused while passing through certain segment of the bowel(such as the left half of colon) ; 2.When training the first-learners, certain dose of sedatives or analgesics was injected; 3.The patients recruited were less. Colonoscopies in this study would be performed by in-training examiners, water would be injected completely instead of air insufflation while advancing the colonoscope, the amount of the water infused would not be predetermined but vary from individuals, and all the patients would be examined without any sedatives or analgesics.

Eligibility criteria: Inclusion Criteria:

* Patients diagnostic colonoscopy;
* Subjets able to provide informed consent

Exclusion Criteria:

* Prior partial or complete colectomy;
* Patients who decline to participate;
* Patients with poor bowel preparation;
* Contraindications of the colonoscopy

Primary outcomes:
measure: The success rate of the cecal intubation within 15 min(%)
timeFrame: This will be calculated after the completion of the whole trial,which is about 2 months
Secondary outcomes:
measure: The cecal intubation time(min);
timeFrame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length
measure: The time to reach the splenic flexure(min)
timeFrame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length
measure: VAS abdominal pain score
timeFrame: Data collected usually within 10minutes post procedure
measure: The frequency of the colonoscope shortening maneuver while advancing the colonoscope
timeFrame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
measure: Length of colonoscope at time of cecal intubation(cm)
timeFrame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
measure: Volume of water used during water colonoscopy(ml)
timeFrame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
measure: General data of the patients recruited-age
timeFrame: Data collected usually within 10minutes post procedure .
measure: General data of the patients recruited-gender
timeFrame: Data collected usually within 10minutes post procedure .
measure: General data of the patients recruited-BMI
timeFrame: Data collected usually within 10minutes post procedure .
measure: General data of the patients recruited-abdominal or pelvic surgery history
timeFrame: Data collected usually within 10minutes post procedure .
measure: General data of the patients recruited-bowel preparation
timeFrame: Data collected usually within 10minutes post procedure .
Other outcomes:
Locations:
city: Harbin
country: China
facility: The Gastroenterology Department of The 1st Affiliated Hospital of Harbin Medical University
state: Heilongjiang
Study officials:
affiliation: The Gastroenterology Department of The 1st Affiliated Hospital of Harbin Medical University
name: Youlin Yang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: