NCT02681692

Brief Summary

Colonoscopy is widely considered as the main choice for patients with suspected colorectal disease,and for screening those at high risk of colorectal cancer. However， colonoscope examination,especially those unsedated ones for screening,may bring much pain to patients,even induce some severe complications such as perforation.Considering the increasing need of colonoscopy examination for screening purpose,it has been a problem deserving of further study that how to reduce pain and ensure safety during the procedure.Some studies suggest that use of Magnetic endoscopic imaging(MEI) during colonoscopy has the potential to ease patient discomfort and reduce complications.Theoretically,the MEI could accurately depict the position of the scope in three dimensions and help avoid forcefully feeding the colonoscope through loops of vulnerable bowel,thus alleviating patient pain and promoting procedure safety.However,the problem whether MEI system could help reduce patient pain during procedure effectively，especially in inexperienced colonoscopists，still remains controversial for researchers,and no study has been designed to test the hypothesis that MEI may help decrease the risk of some complications,such as colon perforation.In this study we aim to evaluate the he efficacy of magnetic scope navigation on patient pain during unsedated colonoscopy；In addition，we try to construct a simple colon force measurement device ,and by using this device to observe the variation of force exerted on colon loop ,we expect to find the potential mechanism of pain-alleviation and explore the possible effect of complication reduction during colonoscopy under the influence of MEI system.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
594

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

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

February 10, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

July 2, 2018

Status Verified

June 1, 2018

Enrollment Period

1.1 years

First QC Date

February 10, 2016

Last Update Submit

June 29, 2018

Conditions

Colonic Diseases

Keywords

colonoscopycolonoscopy educationmagnetic endoscope imagingColonic Diseases

Outcome Measures

Primary Outcomes (2)

  • patients over pain experience

    A pain score would be obtained from patients shortly after each examination. The score would be obtained with the Help of a visual analogue scale ranging from 0(no pain)to10(the worst pain).

    day of colonoscope performance

  • Maximum target colon loop force

    In the second part,The maximum colon force exerted on a chosen target colon loop （we plan to choose one loop of sigmoid colon）would be recorded by the simple colon force measurement device.

    day of colonoscope performance

Secondary Outcomes (7)

  • number of attempts of abdominal hand pressure

    day of colonoscope performance

  • number of patient reposition

    day of colonoscope performance

  • endoscopist perception of ease of procedure

    day of colonoscope performance

  • patient's intention to attend unsedated colonoscopy again

    day of colonoscope performance

  • caecal intubation rate

    one year

  • +2 more secondary outcomes

Study Arms (4)

MEI colonoscopy Group

ACTIVE COMPARATOR

Patients would be randomly assigned to have colonoscopy examination performed by one inexperienced colonoscopist (having performed less than 200 procedures) with the assistance of magnetic scope navigation system

Device: Magnetic endoscopic imaging system

Standard colonoscopy Group

NO INTERVENTION

Patients would be randomly assigned to have colonoscopy examination performed by one inexperienced colonoscopist (having performed less than 200 procedures) without the assistance of magnetic scope navigation system

MEI colon model Group

ACTIVE COMPARATOR

Colonoscopist would be randomized to perform colonoscopy on a colon model with an MEI view while the force measurement device being used to collect data of colon force variation meanwhile. No patients would be involved in this part. All force variation data would be recorded by a image storage device.

Device: Magnetic endoscopic imaging system

Standard colon model Group

NO INTERVENTION

Colonoscopist would be randomized to perform conventional colonoscopy on a colon model without an MEI view while the force measurement device being used to collect data of colon force variation meanwhile. No patients would be involved in this part. All force variation data would be recorded by a image storage device.

Interventions

Magnetic endoscopic imaging systemDEVICE

In the first part,patients would be randomly assigned to have colonoscopy examination performed by one inexperienced colonoscopist (having performed less than 200 procedures) with the assistance of magnetic scope navigation system In the second part colonoscopist would be randomized to perform conventional colonoscopy on a colon model with an MEI view while the force measurement device being used to collect data of colon force variation meanwhile. No patients would be involved in this part. All force variation data would be recorded by a image storage device.

Also known as: magnetic scope navigation system., MEI system
MEI colon model GroupMEI colonoscopy Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • colonoscopists: All colonoscopists are selected from the colonoscopy learners in Endoscopy Center of Shanghai Renji Hospital. Only inexperienced colonoscopists (having performed less than 200 procedures) would be allowed to participate in the first part while both inexperienced colonoscopists and experienced colonoscopists (having performed less than 350 procedures) are allowed to participate in the second part.
  • patients: in the first part: Patients aged between 18 and 75 are recruited to receive unsedated colonoscopy examination with their permission. Written informed consent would be obtained.
  • in the second part:no patient would participate in this part

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (4)

  • Continuing Medical Education Exam: September 2014 James Buxbaum, MD, William Ross, MD, Shou-Jiang Tang, MD, Brian Weston, MD,Co-Editors, CME Section G. S. Raju, MD,Editor, CME Section Glenn M. Eisen, MD, MPH,Editor-in-Chief, Gastrointestinal Endoscopy 503.e1， GASTROINTESTINAL ENDOSCOPY Volume 80, No. 3 : 2014

    BACKGROUND

  • Hoff G, Bretthauer M, Dahler S, Huppertz-Hauss G, Sauar J, Paulsen J, Seip B, Moritz V. Improvement in caecal intubation rate and pain reduction by using 3-dimensional magnetic imaging for unsedated colonoscopy: a randomized trial of patients referred for colonoscopy. Scand J Gastroenterol. 2007 Jul;42(7):885-9. doi: 10.1080/00365520601127125.

    PMID: 17558914BACKGROUND

  • Shah SG, Brooker JC, Williams CB, Thapar C, Saunders BP. Effect of magnetic endoscope imaging on colonoscopy performance: a randomised controlled trial. Lancet. 2000 Nov 18;356(9243):1718-22. doi: 10.1016/S0140-6736(00)03205-0.

    PMID: 11095259BACKGROUND

  • Kaltenbach T, Leung C, Wu K, Yan K, Friedland S, Soetikno R. Use of the colonoscope training model with the colonoscope 3D imaging probe improved trainee colonoscopy performance: a pilot study. Dig Dis Sci. 2011 May;56(5):1496-502. doi: 10.1007/s10620-011-1614-1. Epub 2011 Mar 16.

    PMID: 21409379BACKGROUND

MeSH Terms

Conditions

Colonic Diseases

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of digestive endoscopy center of Renji hospital

Study Record Dates

First Submitted

February 10, 2016

First Posted

February 12, 2016

Study Start

April 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

July 2, 2018

Record last verified: 2018-06

Locations

CN(1)