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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.

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

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

NCT ID

NCT01797393

First Posted

February 20, 2013

Last Updated

February 21, 2013

Sponsor

First Affiliated Hospital of Harbin Medical University

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

Arm Title

Water injection colonoscopy

Arm Type

Experimental

Arm Description

Arm Title

" Air assisted" water colonoscopy

Arm Type

Experimental

Arm Description

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