Segmental Water Exchange Method in Patients With Unsedated Colonoscopy
| Tracking Information | |||||
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| First Received Date ICMJE | November 23, 2012 | ||||
| Last Updated Date | November 27, 2012 | ||||
| Start Date ICMJE | October 2012 | ||||
| Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Cecal intubation success rate [ Time Frame: up to six months ] [ Designated as safety issue: No ] The rate of subjects with complete colonoscopy (insertion of the colonoscope tip into the cecal caput). |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01735266 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Segmental Water Exchange Method in Patients With Unsedated Colonoscopy | ||||
| Official Title ICMJE | Water Exchange Colonoscopy Versus Air Colonoscopy for Unsedated Patients: a Prospective Randomized, Controlled, Patient-blind Trial | ||||
| Brief Summary | Colonoscopy is widely used for diagnosis and management of colorectal diseases. Conventional colonoscopy with air insufflation may distend, lengthen and distend the colon lead to increased discomfort of patients and difficulty of cecal intubation. The use of water infusion in lieu of air insufflation (water exchange method) obviates excessive lengthening of the colon, and facilitates completion of colonoscopy. Several studies revealed that the total colonic water exchange method can significantly reduce the pain score and enhance the success of cecal intubation in minimal-sedation or unsedated colonoscopy. However, this method was associate with long operation time. Due to the special anatomic structure of sigmoid and descending colon (the left side of the colon), passage through this region is more difficult during colonoscopy. The investigators hypothesized that the critical superiority of water-aided colonoscopy is avoiding of lengthening and looping of sigmoid and descending colon. So, compare with total colonic water exchange method, the segmental colonic water exchange method should get the same effect with less operation time. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Screening |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 282 | ||||
| Estimated Completion Date | October 2013 | ||||
| Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01735266 | ||||
| Other Study ID Numbers ICMJE | 20121108-5 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Yanglin Pan, Fourth Military Medical University | ||||
| Study Sponsor ICMJE | Fourth Military Medical University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Fourth Military Medical University | ||||
| Verification Date | November 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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