UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003464 |
|---|---|
| Receipt number | R000004193 |
| Scientific Title | Multicenter prospective trial of colonoscopy using short length double balloon endoscopy for patients with previous incomplete colonoscopy |
| Date of disclosure of the study information | 2010/04/12 |
| Last modified on | 2012/02/02 06:57:31 |
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Basic information
Public title
Multicenter prospective trial of colonoscopy using short length double balloon endoscopy for patients with previous incomplete colonoscopy
Acronym
Multicenter prospective trail of double balloon colonoscopy
Scientific Title
Multicenter prospective trial of colonoscopy using short length double balloon endoscopy for patients with previous incomplete colonoscopy
Scientific Title:Acronym
Multicenter prospective trail of double balloon colonoscopy
Region
| Japan |
Condition
Condition
Colorectal disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effectiveness of double balloon colonoscopy for patients with previous incomplete colonoscopy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of complete colonoscopy
Key secondary outcomes
Insertion time
Complication
Pain during procedure
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Double balloon colonoscopy
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who had underwent incomplete colonoscopy
Key exclusion criteria
Past history of colorectal surgery
Insufficient preparation
GI polyposis syndrome
IBD
Pregnancy
On-going GI obstruction
On-going GI bleeding
Severe heart or respiratory failure
Dementia
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kinichi Hotta |
Organization
Saku central hospital
Division name
Department of Gastroenterology
Zip code
Address
Usuda 197, Saku, Nagano, Japan
TEL
0267-82-3131
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kinichi Hotta |
Organization
Saku central hospital
Division name
Department of Gastroenterology
Zip code
Address
Usuda 197, Saku, Nagano, Japan
TEL
0267-82-3131
Homepage URL
kinichi1@janis.or.jp
Sponsor or person
Institute
DBC study group
Institute
Department
Personal name
Funding Source
Organization
No English name
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Fuji film medical co
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
① 佐久総合病院（長野県）
② 静岡県立静岡がんセンター（静岡県）
③ 岡山大学病院（岡山県）
④ 宝塚市立病院（兵庫県）
⑤ 京都桂病院（京都府）
⑥ 仙台厚生病院（宮城県）
⑦ 小樽棭済会病院（北海道）
⑧ 岩手医科大学医学部附属病院（岩手県）
⑨ 関西医科大学附属枚方病院（大阪府）
⑩ 信州大学医学部附属病院（長野県）
⑪ NTT東日本関東病院(東京）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/22284085
Number of participants that the trial has enrolled
Results
A total of 110 patients (62 males, median age 66.5 years) were included. Fifty-four patients had a history of abdominal surgery. The cecal intubation rate was 100% (110/110). Median intubation time was 12 minutes (range 4-47 minutes). Mild mucosal tears without symptoms occurred in 1 patient. For 64.5% of patients, intravenous sedatives and/or analgesics were used during examinations. Based on questionnaires, 50.9% had no pain, 31.8% slight pain, and 17.3% tolerable pain. Moreover, 96.4% of patients answered that their examination was more comfortable than their previous colonoscopy.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 02 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 08 | Day |
Last modified on
| 2012 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004193
