"Air Assisted"Water Injection Colonoscopy in Experienced Endoscopists

Rectal Disease Clinical Trial

Official title:

"Air Assisted"Water Injection Colonoscopy in Experienced Endoscopists

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01797393
• Other study ID #: WIC-001
• Status: Recruiting
• Phase: N/A
• First received: February 20, 2013
• Last updated: February 21, 2013
• Start date: February 2013
• Est. completion date: April 2013

Study information

• Verified date: February 2013
• Source: First Affiliated Hospital of Harbin Medical University
• Contact: Youlin Yang, M.D.
• Phone: 8613604809322
• Email: dr.yangylin[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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 investigators conduct this study to preform the "air assisted" water injection colonoscopy in experienced endoscopists.

Description:

In order to further develop water skills and apply the water assisted colonoscopy technique more flexibly, the investigators designed this study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colon Disease;
• Colonic Diseases
• Rectal Disease
• Rectal Diseases

Intervention

Other:
• Air insufflation
Air is inflated into the bowel to help searching the cavity while advancing the colonoscope until reaching the cecum.
• Water injection
Water was injected through the working channel instead of air to follow the intestinal cavity until reaching the caecum .
• " Air assisted" water injection.
Cut off air inflating before examination. Water was injected through the working channel to follow the intestinal cavity until reaching the splenic flexure, small amount of air inflating could be given to help searching the cavity until reaching the cecum.

Locations

Country	Name	City	State
China	The 1st Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The success rate of the cecal intubation		This will be calculated after the completion of the whole trial,which is about 2 months	No
Secondary	The cecal intubation time(min)		This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length	No
Secondary	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	No
Secondary	VAS abdominal pain score		Data collected usually within 10minutes post procedure	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	General data of the patients recruited-age		Data collected usually within 10minutes post procedure .	No
Secondary	General data of the patients recruited-gender		Data collected usually within 10minutes post procedure .	No
Secondary	General data of the patients recruited-BMI		Data collected usually within 10minutes post procedure .	No
Secondary	General data of the patients recruited-abdominal or pelvic surgery history		Data collected usually within 10minutes post procedure .	No
Secondary	General data of the patients recruited-bowel preparation		Data collected usually within 10minutes post procedure .	No
Secondary	The McGill pain evaluation of the abdominal pain		Data collected usually within 10minutes post procedure	No