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Trial record 14 of 3559 for:    colon cancer AND Colonic Diseases

Effect of Magnetic Endoscopic Imaging on Patient Pain During Colonoscopy

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ClinicalTrials.gov Identifier: NCT02681692
Recruitment Status : Completed
First Posted : February 12, 2016
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Zhizheng Ge, Shanghai Jiao Tong University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Colonic Diseases Device: Magnetic endoscopic imaging system Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 594 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Official Title: Effect of Magnetic Endoscopic Imaging on Patient Pain During Colonoscopy: a Randomized, Controlled Trial Using a Simple Colon Force Measurement Device
Study Start Date : April 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. patients over pain experience [ Time Frame: day of colonoscope performance ]
    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).

  2. Maximum target colon loop force [ Time Frame: day of colonoscope performance ]
    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.


Secondary Outcome Measures :
  1. number of attempts of abdominal hand pressure [ Time Frame: day of colonoscope performance ]
  2. number of patient reposition [ Time Frame: day of colonoscope performance ]
  3. endoscopist perception of ease of procedure [ Time Frame: day of colonoscope performance ]
    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).

  4. patient's intention to attend unsedated colonoscopy again [ Time Frame: day of colonoscope performance ]
    patients need to answer "yes"or"no"

  5. caecal intubation rate [ Time Frame: one year ]
    Criteria for reaching the caecum are identification of the ileocaecal valve

  6. caecal intubation time [ Time Frame: day of colonoscope performance ]
  7. ime for the colonoscopist to advance to splenic flexure of colon [ Time Frame: day of colonoscope performance ]
    In the second part,time for the colonoscopist to advance to splenic flexure of colon would be recorded.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02681692


Locations
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China, Shanghai
Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai, China, 200127
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine

Publications:
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Responsible Party: Zhizheng Ge, Director of digestive endoscopy center of Renji hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02681692     History of Changes
Other Study ID Numbers: rj(2015)086k
First Posted: February 12, 2016    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018
Keywords provided by Zhizheng Ge, Shanghai Jiao Tong University School of Medicine:
colonoscopy
colonoscopy education
magnetic endoscope imaging
Colonic Diseases
Additional relevant MeSH terms:
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Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases