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Single center randomized control trial of ultra-slim colonoscope with passive bending and high force transmission (PCF-PQ260) versus conventionally used slim colonoscope for unsedated colonoscopy in inflammatory bowel disease (IBD) patients.

Single center randomized control trial of ultra-slim colonoscope with passive bending and high force transmission (PCF-PQ260) versus conventionally used slim colonoscope for unsedated colonoscopy in inflammatory bowel disease (IBD) patients. - PCF-PQ260 study for IBD

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000008169
Enrollment
120
Registered
2012-06-14
Start date
2012-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Disease

Interventions

II.Intervened group: Patients who are randomly assigned to receive total colonoscopy with PCF-PQ260. Intervention is at the day when patients are examined by total colonoscopy. II.Control group: Patie

Sponsors

Hyogo College of Medicine, Dept. of Internal medicine, Lower gastroenterology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: I.IBD patients undergoing an elective, diagnostic, or screening colonoscopy at Hyogo college of Medicine Hospital are prospectively included. II.Patients who had a diagnosis of IBD before colonoscopy III.Patient was able to provide written informed consent to total colonoscopy basically without sedation and being randomized to the new ultrathin flexible scope (PCF-PQ260) group or to the conventional scope (PCF-Q260A) group. IV.Patients aged 18 or older.

Exclusion criteria

Exclusion criteria: I.Cases of the short bowel syndrome. II.Cases that have obvious bleeding from intestine and possibility of perforation. III.Cases of the megacolon or toxic megacolon. IV.Cases that have severe stenosis or adhesion. V.Cases that have severe inflammation and high risk for colonoscopy. VI.Patients could not provide consent or when patients preferred to receive sedation/analgesia from the start. VII.Patient had undergone prior partial colonic resection VIII.Cases whose preparation was incomplete before colonoscopy

Design outcomes

Primary

MeasureTime frame
I. Patients rating of procedural pain related to colonoscopy by visual analogue scale

Secondary

MeasureTime frame
II. The facilitation of intubation II-1. Completeness of intubation to the cecum II-2. Time required for intubation to the cecum III. Procedural complications in colonoscopy

Countries

Japan

Contacts

Public ContactYoshio Ohda MD.Ph.D.

Hyogo College of Medicine Dept.of Internal medicine, Lower gastroenterology

y-ohda@hyo-med.ac.jp0798-45-6662

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026