Water Injection Colonoscopy vs Air Insufflation Colonoscopy in Training the Beginners

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.

Study Overview

• Status: Unknown
• Conditions: Pain; Colon Disease; Rectal Disease
• Intervention / Treatment: Other: Air insufflation; Other: Water injection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150001
      • Recruiting
      • The Gastroenterology Department of The 1st Affiliated Hospital of Harbin Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Air insufflation colonoscopy; Air insufflation colonoscopy is the conventional colonoscopy,which is inflating air to help searching the bowel cavity while advancing the colonoscope until reaching the cecum.All the patients were examined without sedation during the whole procedure.	Other: Air insufflation; Air is inflated into the bowel to help searching the cavity while advancing the colonoscope until reaching the cecum.
EXPERIMENTAL: Water injection colonoscopy; Water injection colonoscopy : Cut off air inflating before examination. Water was injected through the working channel to follow the intestinal cavity until reaching the caecum .All the patients were examined without sedation during the whole procedure.	Other: Water injection; Water was injected through the working channel instead of air to follow the intestinal cavity until reaching the caecum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The success rate of the cecal intubation within 15 min(%)	This will be calculated after the completion of the whole trial,which is about 2 months

Secondary Outcome Measures

Outcome Measure	Time Frame
The cecal intubation time(min);	This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length
The time to reach the splenic flexure(min)	This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length
VAS abdominal pain score	Data collected usually within 10minutes post procedure
The frequency of the colonoscope shortening maneuver while advancing the colonoscope	This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
Length of colonoscope at time of cecal intubation(cm)	This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
Volume of water used during water colonoscopy(ml)	This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
General data of the patients recruited-age	Data collected usually within 10minutes post procedure .
General data of the patients recruited-gender	Data collected usually within 10minutes post procedure .
General data of the patients recruited-BMI	Data collected usually within 10minutes post procedure .
General data of the patients recruited-abdominal or pelvic surgery history	Data collected usually within 10minutes post procedure .
General data of the patients recruited-bowel preparation	Data collected usually within 10minutes post procedure .

Collaborators and Investigators

• Sponsor: Youlin Yang ,MD

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (ANTICIPATED): March 1, 2013
• Study Completion (ANTICIPATED): March 1, 2013

Study Registration Dates

• First Submitted: January 3, 2013
• First Submitted That Met QC Criteria: January 7, 2013
• First Posted (ESTIMATE): January 8, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): February 12, 2013
• Last Update Submitted That Met QC Criteria: February 10, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Colonic Diseases; Rectal Diseases
• Other Study ID Numbers: WIC-002