NCT01762735

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 8, 2013

Completed
24 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

February 12, 2013

Status Verified

February 1, 2013

Enrollment Period

28 days

First QC Date

January 3, 2013

Last Update Submit

February 10, 2013

Conditions

Colon DiseaseRectal DiseasePain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • 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.

  • +6 more secondary outcomes

Study Arms (2)

Air insufflation colonoscopy

ACTIVE COMPARATOR

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

Water injection colonoscopy

EXPERIMENTAL

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

Interventions

Air insufflationOTHER

Air is inflated into the bowel to help searching the cavity while advancing the colonoscope until reaching the cecum.

Air insufflation colonoscopy
Water injectionOTHER

Water was injected through the working channel instead of air to follow the intestinal cavity until reaching the caecum.

Water injection colonoscopy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnostic colonoscopy;
  • Subjets able to provide informed consent

You may not qualify if:

  • Prior partial or complete colectomy;
  • Patients who decline to participate;
  • Patients with poor bowel preparation;
  • Contraindications of the colonoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Harbin, Heilongjiang, 150001, China

RECRUITING

MeSH Terms

Conditions

Colonic DiseasesRectal DiseasesPain

Interventions

Water

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Youlin Yang, M.D.

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Youlin Yang, M.D.

CONTACT

8613604809322dr.yangylin@163.com

Xiaobing Wang, Master

CONTACT

8613936135056wxbangel@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 3, 2013

First Posted

January 8, 2013

Study Start

February 1, 2013

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

February 12, 2013

Record last verified: 2013-02

Locations

CN(1)