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"Air Assisted"Water Injection Colonoscopy in Experienced Endoscopists

Primary Purpose

Colon Disease;, Rectal Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Air insufflation
Water injection
" Air assisted" water injection.
Sponsored by
First Affiliated Hospital of Harbin Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colon Disease;

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The 1st Affiliated Hospital of Harbin Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Air insufflation colonoscopy

Water injection colonoscopy

" Air assisted" water colonoscopy

Arm Description

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.

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 .The mucosa was observed by inflating the bowel with air while withdrawing the colonoscope.All the patients were examined without sedation during the whole procedure.

" Air assisted" water injection colonoscopy: 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.All the patients were examined without sedation during the whole procedure.

Outcomes

Primary Outcome Measures

The success rate of the cecal intubation

Secondary Outcome Measures

The cecal intubation time(min)
The time to reach the splenic flexure(min)
VAS abdominal pain score
The frequency of the colonoscope shortening maneuver while advancing the colonoscope
Length of colonoscope at time of cecal intubation(cm)
Volume of water used during water colonoscopy(ml)
General data of the patients recruited-age
General data of the patients recruited-gender
General data of the patients recruited-BMI
General data of the patients recruited-abdominal or pelvic surgery history
General data of the patients recruited-bowel preparation
The McGill pain evaluation of the abdominal pain

Full Information

First Posted
February 20, 2013
Last Updated
February 21, 2013
Sponsor
First Affiliated Hospital of Harbin Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01797393
Brief Title
"Air Assisted"Water Injection Colonoscopy in Experienced Endoscopists
Official Title
"Air Assisted"Water Injection Colonoscopy in Experienced Endoscopists
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
April 2013 (Anticipated)
Study Completion Date
April 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Harbin Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Disease;, Rectal Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Air insufflation colonoscopy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Water injection colonoscopy
Arm Type
Experimental
Arm Description
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 .The mucosa was observed by inflating the bowel with air while withdrawing the colonoscope.All the patients were examined without sedation during the whole procedure.
Arm Title
" Air assisted" water colonoscopy
Arm Type
Experimental
Arm Description
" Air assisted" water injection colonoscopy: 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.All the patients were examined without sedation during the whole procedure.
Intervention Type
Other
Intervention Name(s)
Air insufflation
Intervention Description
Air is inflated into the bowel to help searching the cavity while advancing the colonoscope until reaching the cecum.
Intervention Type
Other
Intervention Name(s)
Water injection
Intervention Description
Water was injected through the working channel instead of air to follow the intestinal cavity until reaching the caecum .
Intervention Type
Other
Intervention Name(s)
" Air assisted" water injection.
Intervention Description
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.
Primary Outcome Measure Information:
Title
The success rate of the cecal intubation
Time Frame
This will be calculated after the completion of the whole trial,which is about 2 months
Secondary Outcome Measure Information:
Title
The cecal intubation time(min)
Time Frame
This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length
Title
The time to reach the splenic flexure(min)
Time Frame
This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length
Title
VAS abdominal pain score
Time Frame
Data collected usually within 10minutes post procedure
Title
The frequency of the colonoscope shortening maneuver while advancing the colonoscope
Time Frame
This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
Title
Length of colonoscope at time of cecal intubation(cm)
Time Frame
This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
Title
Volume of water used during water colonoscopy(ml)
Time Frame
This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
Title
General data of the patients recruited-age
Time Frame
Data collected usually within 10minutes post procedure .
Title
General data of the patients recruited-gender
Time Frame
Data collected usually within 10minutes post procedure .
Title
General data of the patients recruited-BMI
Time Frame
Data collected usually within 10minutes post procedure .
Title
General data of the patients recruited-abdominal or pelvic surgery history
Time Frame
Data collected usually within 10minutes post procedure .
Title
General data of the patients recruited-bowel preparation
Time Frame
Data collected usually within 10minutes post procedure .
Title
The McGill pain evaluation of the abdominal pain
Time Frame
Data collected usually within 10minutes post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Youlin Yang, M.D.
Phone
8613604809322
Email
dr.yangylin@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaobing Wang, Master
Phone
8613936135056
Email
wxbangel@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Youlin Yang, M.D.
Organizational Affiliation
Gastroenterology Department of The 1st Affiliated Hospital of Harbin Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The 1st Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Youlin Yang, M.D.
Phone
8613604809322
Email
dr.yangylin@163.com
First Name & Middle Initial & Last Name & Degree
Xiaobing Wang, Master
Phone
8613936135056
Email
wxbangel@sina.com
First Name & Middle Initial & Last Name & Degree
Youlin Yang, M.D.

12. IPD Sharing Statement

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"Air Assisted"Water Injection Colonoscopy in Experienced Endoscopists

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