Effect of Magnetic Endoscopic Imaging on Patient Pain During Colonoscopy

Effect of Magnetic Endoscopic Imaging on Patient Pain During Colonoscopy: a Randomized, Controlled Trial Using a Simple Colon Force Measurement Device

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.

Study Overview

• Status: Completed
• Conditions: Colonic Diseases
• Intervention / Treatment: Device: Magnetic endoscopic imaging system

Detailed Description

This clinical trial is planned as two parts:In the first part,consecutive patients would be recruited and randomized to have colonoscopy examination performed by inexperienced colonoscopists (having performed less than 200 procedures) either with or without the assistance of magnetic scope navigation system. The second part would be conducted as a pilot study,we would first construct a simple colon force measurement device;then colonoscopist would be randomized to perform colonoscopy on a colon model either with or without an MEI view while the force measurement device being used to collect data of colon force variation meanwhile. All force variation data would be recorded by a image storage device.No patients would be involved in the second part.In this pilot study, we plan to perform 40 colonoscopy procedures with the assistance of MEI and 40 colonoscopy procedures without the assistance of MEI.

• Study Type: Interventional
• Enrollment (Actual): 594
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria： patients:consecutive patients,excluding inpatients,pregnant,who had a known or suspected colonic stricture or obstruction, who had previous history of abdominal surgery,who had severe comorbid cardiopulmonary,kidney,liver conditions,who had pacemakers or internal defibrillators,who were unable to give informed consent,who have active gastrointestinal bleeding are recruited

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MEI colonoscopy Group; 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; 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.; Other Names: magnetic scope navigation system.; MEI system
No Intervention: Standard colonoscopy Group; 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
Active Comparator: MEI colon model Group; 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; 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.; Other Names: magnetic scope navigation system.; MEI system
No Intervention: Standard colon model Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Endoscopist are asked to score the ease of each procedure after completion,using a ten-point scoring system(ease-of-procedure score)form 0(easiest)to 10(most difficult).	day of colonoscope performance
patient's intention to attend unsedated colonoscopy again	patients need to answer "yes"or"no"	day of colonoscope performance
caecal intubation rate	Criteria for reaching the caecum are identification of the ileocaecal valve	one year
caecal intubation time		day of colonoscope performance
ime for the colonoscopist to advance to splenic flexure of colon	In the second part，time for the colonoscopist to advance to splenic flexure of colon would be recorded.	day of colonoscope performance

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: February 10, 2016
• First Submitted That Met QC Criteria: February 10, 2016
• First Posted (Estimate): February 12, 2016

Study Record Updates

• Last Update Posted (Actual): July 2, 2018
• Last Update Submitted That Met QC Criteria: June 29, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: colonoscopy; Colonic Diseases; magnetic endoscope imaging; colonoscopy education
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Colonic Diseases
• Other Study ID Numbers: rj（2015）086k