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Water Injection Colonoscopy vs Air Insufflation Colonoscopy in Training the Beginners

Primary Purpose

Colon Disease, Rectal Disease, Pain

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Air insufflation

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 Gastroenterology Department of The 1st Affiliated Hospital of Harbin Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Air insufflation colonoscopy

Water injection 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 .All the patients were examined without sedation during the whole procedure.

Outcomes

Primary Outcome Measures

The success rate of the cecal intubation within 15 min(%)

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

Full Information

NCT ID

NCT01762735

First Posted

January 3, 2013

Last Updated

February 10, 2013

Sponsor

Youlin Yang ,MD

1. Study Identification

Unique Protocol Identification Number

NCT01762735

Brief Title

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

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Unknown status

Study Start Date

February 2013 (undefined)

Primary Completion Date

March 2013 (Anticipated)

Study Completion Date

March 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Youlin Yang ,MD

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

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

Colon Disease, Rectal Disease, Pain

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

300 (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

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.

Primary Outcome Measure Information:

Title

The success rate of the cecal intubation within 15 min(%)

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