Effect of Magnetic Endoscopic Imaging on Patient Pain During Colonoscopy
Condition: Colonic Diseases
MeSH terms: Colonic Diseases
Study type: Interventional

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.
    

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.
    

Intervention name(s): Magnetic endoscopic imaging system
Intervention type(s): Device
Intervention description(s): 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 intervention name(s): magnetic scope navigation system.; MEI system
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: colonoscopy; colonoscopy education; magnetic endoscope imaging; Colonic Diseases