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Status unknownNCT01919463SINOCOLO2013Updated Mar 3, 2015

Intubation Techniques on Colonoscopy Quality (SINOCOLO2013)

An interventional study of Abdominal Compression and Guidance of Magnetic Endoscopic Imaging (MEI) System in Colorectal Adenoma and Colorectal Polyp, sponsored by Changhai Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-03.

Sponsored by Changhai Hospital · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The primary aim of this study is

  • to explore the usefulness of abdominal compression on intubation.

Other aims include

  1. to investigate the effectiveness and the efficacy of different manners of abdominal compression and to analysis the reasons of their success and failure
  2. to get the knowledge of the formation of colon loops and its frequency
  3. to clarify the impact of intubation with loops on adenoma detection rate
02

Conditions studied

  • Colorectal Adenoma
  • Colorectal Polyp

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Keywords

  • Colonoscopy
  • Lower Gastrointestinal Tract
  • Magnetic Endoscopic Imaging
  • Abdominal Compression
03

In context

Adenoma

657 studies on the registry are indexed under Adenoma; 98 are open to participants now.

This study's planned enrollment of 300 is above the median of 250 across 412 interventional studies indexed under Adenoma.

Browse Adenoma studies →

Lead sponsor

Changhai Hospital is the lead sponsor of 342 studies on the registry; 133 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients who undergo colonoscopy examination for screening, surveillance, diagnosis or treatment

Exclusion criteria

Exclusion Criteria:

  • Pregnant female patients
  • Patients who have history of colorectal cancer, colorectal polyposis, inflammatory bowel disease or heredity colorectal neoplasm syndrome such as familiar adenomatous polyposis, Lynch Syndrome and so on
  • Patients who had previous abdominal surgery
  • Patients who are known to have colonic stricture or obstructing tumor from the results of radiography (X ray, CT scan or barium enema)
  • Patients who are presenting acute surgical conditions such as severe colitis, megacolon and active gastrointestinal bleeding
  • Patients who have inadequate bowel preparation
  • Patients who reject to participate in this study
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • No intervention
    Control Group

    Colonoscopy is completed without abdominal compression by GI assistants. Live image of magnetic endoscopic imaging system is shown to investigators for study but not to the colonoscopist for facilitating the intubation process.

  • Experimental
    Experimental Group 2 (Monitoring)

    Colonoscopy is completed with abdominal compression by GI assistants. Live image of magnetic endoscopic imaging system is shown to investigators for study but not to the colonoscopist for facilitating the intubation process. The colonoscopist directs GI assistants to conduct compression by his subjective judgement.

    Behavioral: Abdominal Compression

  • Experimental
    Experimental Group 1 (Guiding)

    Colonoscopy is completed with abdominal compression by GI assistants. Live image of magnetic endoscopic imaging system is shown both to investigators for study and to the colonoscopist for facilitating the intubation process. The colonoscopist directs GI assistants to conduct compression according to the guidance of magnetic endoscopic imaging system.

    Behavioral: Abdominal Compression · Device: Guidance of Magnetic Endoscopic Imaging (MEI) System

Interventions

  • BehavioralAbdominal Compression

    Abdominal Compression is conducted by GI assistants during intubation process to facilitate the process. It can be conducted at different ares of the abdomen with different force.

  • DeviceGuidance of Magnetic Endoscopic Imaging (MEI) System

    Live image of MEI can show the form of the colonoscope inside the body. Live image is show to colonoscopist for facilitating the intubation process.

    Also known as: MEI System (Olympas, Tokyo, Japan)

06

What researchers measure

Primary outcomes

  1. Mean Intubation Time (MIT)

    MIT refers to the mean of intubation time. Intubation time refers to the time spent on the intubation procedure. Intubation is defined as the procedure during which the tip of the colonoscope reaches the cecum from the anus.

    Time frame: At the end of the procedure, up to 1 hour

Secondary outcomes

  1. Cecal Intubation Rate (CIR)

    CIR refers to the proportion of the subjects who receive the whole colon examination. The whole colon examination means the tip of the colonoscope reaches the cecum during the procedure.

    Time frame: At the end of the procedure, up to 1 hour

  2. Pain Score (PS)

    PS is measure by the numerical rating scale during the intubation process. Numerical rating scale contains 11 ranks from 0 to 10, in which 0 means no pain and 10 means the extreme pain cannot be borne.

    Time frame: During the procedure, up to 1 hour

  3. Severe Adverse Event Rate (SAER)

    SAER refers to the proportion of the subjects to whom severe adverse events happens. Severe adverse events include perforation, massive hemorrhage, lethal arrhythmia, death and so on.

    Time frame: The day of the procedure, 24 hours

  4. Adenoma Detection Rate (ADR)

    ADR refer to the rate of adenoma detection, calculated as the proportion of subjects with at least one adenoma.

    Time frame: At the end of the procedure, up to 1 hour

  5. Polyp Detection Rate (PDR)

    PDR refer to the rate of polyp detection, calculated as the proportion of subjects with at least one polyp.

    Time frame: At the end of the procedure, up to 1 hour

07

Study locations

1 of 1 sites recruiting
  • Changhai Hospital
    Shanghai, Shanghai 200433, China
    • En-Da Yu, M.D. · Contact · 08615921509177
    • En-Da Yu, M.D. · Principal investigator
    Recruiting
08

References and documents

Publications

  • Shah SG, Saunders BP, Brooker JC, Williams CB. Magnetic imaging of colonoscopy: an audit of looping, accuracy and ancillary maneuvers. Gastrointest Endosc. 2000 Jul;52(1):1-8. doi: 10.1067/mge.2000.107296. PubMed 10882954 ↗
  • Holme O, Hoie O, Matre J, Stallemo A, Garborg K, Hasund A, Wiig H, Hoff G, Bretthauer M. Magnetic endoscopic imaging versus standard colonoscopy in a routine colonoscopy setting: a randomized, controlled trial. Gastrointest Endosc. 2011 Jun;73(6):1215-22. doi: 10.1016/j.gie.2011.01.054. Epub 2011 Apr 8. PubMed 21481862 ↗
  • Cheung HY, Chung CC, Kwok SY, Tsang WW, Li MK. Improvement in colonoscopy performance with adjunctive magnetic endoscope imaging: a randomized controlled trial. Endoscopy. 2006 Mar;38(3):214-7. doi: 10.1055/s-2005-921172. PubMed 16528645 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01919463
Lead sponsor
Changhai Hospital
Responsible party
En-Da Yu (Surgical Professor, Vice Director of Department of Colorectal Surgery and Center of GI Endoscopy, Changhai Hospital) — Principal investigator
First posted
Aug 9, 2013
Start date
Mar 2015
Primary completion
Aug 2015 (estimated)
Completion
Feb 2016 (estimated)
Last update
Mar 3, 2015

Study contacts

En-Da Yu, M.D.
Contact
endayu@yeah.net
08615921509177
En-Da Yu, M.D.
principal investigator · Changhai Hospital, Shanghai, China

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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