CClinicalTrials.gg
Status unknownNCT01797393Updated Feb 25, 2013

"Air Assisted"Water Injection Colonoscopy in Experienced Endoscopists

An interventional study of Air insufflation and Water injection in Colon Disease; and Rectal Disease, sponsored by First Affiliated Hospital of Harbin Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-02-25.

Sponsored by First Affiliated Hospital of Harbin Medical University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Feb 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

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

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Conditions studied

  • Colon Disease;
  • Rectal Disease
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In context

Rectal Diseases

64 studies on the registry are indexed under Rectal Diseases; 14 are open to participants now.

This study's planned enrollment of 600 is above the median of 124 across 43 interventional studies indexed under Rectal Diseases.

Browse Rectal Diseases studies →

Lead sponsor

First Affiliated Hospital of Harbin Medical University is the lead sponsor of 73 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
600 participants (estimated)

Study arms

  • Active comparator
    Air insufflation colonoscopy

    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

  • Experimental
    Water injection colonoscopy

    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.

    Other: Water injection

  • Experimental
    " Air assisted" water colonoscopy

    " 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.

    Other: " Air assisted" water injection.

Interventions

  • OtherAir insufflation

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

  • OtherWater injection

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

  • Other" 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.

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What researchers measure

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. VAS abdominal pain score

    Time frame: Data collected usually within 10minutes post procedure

  4. 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.

  5. 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.

  6. 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.

  7. General data of the patients recruited-age

    Time frame: Data collected usually within 10minutes post procedure .

  8. General data of the patients recruited-gender

    Time frame: Data collected usually within 10minutes post procedure .

  9. General data of the patients recruited-BMI

    Time frame: Data collected usually within 10minutes post procedure .

  10. General data of the patients recruited-abdominal or pelvic surgery history

    Time frame: Data collected usually within 10minutes post procedure .

  11. General data of the patients recruited-bowel preparation

    Time frame: Data collected usually within 10minutes post procedure .

  12. The McGill pain evaluation of the abdominal pain

    Time frame: Data collected usually within 10minutes post procedure

07

Study locations

1 of 1 sites recruiting
  • The 1st Affiliated Hospital of Harbin Medical University
    Harbin, Heilongjiang 150001, China
    • Youlin Yang, M.D. · Contact · dr.yangylin@163.com · 8613604809322
    • Xiaobing Wang, Master · Contact · wxbangel@sina.com · 8613936135056
    • Youlin Yang, M.D. · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01797393
Lead sponsor
First Affiliated Hospital of Harbin Medical University
Responsible party
Sponsor
First posted
Feb 22, 2013
Start date
Feb 2013
Primary completion
Apr 2013 (estimated)
Completion
Apr 2013 (estimated)
Last update
Feb 25, 2013

Study contacts

Youlin Yang, M.D.
Contact
dr.yangylin@163.com
8613604809322
Xiaobing Wang, Master
Contact
wxbangel@sina.com
8613936135056
Youlin Yang, M.D.
principal investigator · Gastroenterology Department of The 1st Affiliated Hospital of Harbin Medical University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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