UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057121 |
|---|---|
| Receipt number | R000061128 |
| Scientific Title | Usefulness of Retroflex Observation in Ascending Colon during Colonoscopy |
| Date of disclosure of the study information | 2025/02/24 |
| Last modified on | 2025/03/21 16:06:52 |
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Basic information
Public title
Usefulness of Retroflex Observation in Ascending Colon during Colonoscopy
Acronym
Usefulness of Retroflex Observation in Ascending Colon
Scientific Title
Usefulness of Retroflex Observation in Ascending Colon during Colonoscopy
Scientific Title:Acronym
Usefulness of Retroflex Observation in Ascending Colon
Region
| Japan |
Condition
Condition
Colorectal Adenoma, Colorectal Cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In Japan, mobidity and motality of colorectal cancer is ranked first (2019) and second (2020), respectively. In response to this situation, colonoscopy has become widespread as a modality of preventing colorectal cancer, but the skill of the inspector and the complex structure of the large intestine make this examination problematic in terms of overlooking lesions and accuracy. In particular, the folds in the ascending colon are high, and lesions can be hidden and difficult to find. In addition, the number of cases of right-sided colon cancer has been increasing in recent years, and the mechanism of colorectal cancer development in this area has also attracted attention. In response to this situation, in addition to the conventional forward view observation to improve the accuracy of ascending colon observation, it has been reported that retroflex observation can increase the lesion detection rate by about 10-15%. There have been several such reports from overseas, but there are few reports from Japan, where endoscopic technology is more advanced than in other countries. In addition, the retroflex observation method for the right-sided colon has not yet been fully adopted in actual endoscopic examination in Japan. In this study, we aimed to verify the extent to which an additional benefit in the detection rate of neoplastic polyps could be achieved by adding retroflex observation to conventional forward view observation in the ascending colon, and at the same time, by performing a second forward view observation afterwards, to verify the rate at which neoplastic polyps are overlooked by retroflex observation after foward view observation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ascending Colon- Adenoma Detection Rate(AC-ADR) in the each examination phase
Key secondary outcomes
Adenoma Miss Rate (AMR) in observation 1 and observation 1 + 2 per examination, the rate of cases where adenomas were found in observation 2, the success rate of retroflex observation in the ascending colon, the average pain score (0 points: no pain, 5 points: most severe pain) and complication rate during retroflex observation in the ascending colon.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Observing the ascending colon during colonoscopy, in addition to the usual forward observation, retroflex observation and a second forward observation are also performed to examine the adenoma detection rate and adenoma miss rate.
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
| 40 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients aged 40 years or older
2) Patients who have tested positive for occult blood in their stool and are planning to undergo a colonoscopy for abdominal symptoms
3) Patients who have had endoscopic resection of early colorectal cancer or colonic polyps in the past and are planning to undergo a colonoscopy for follow-up purposes.
4) Patients who have given written informed consent to participate in the study.
Key exclusion criteria
1) Patients with inflammatory bowel disease
2) Patients suffering from gastrointestinal polyposis, including familial adenomatous polyposis
3) Patients with a history of colorectal surgery
4) Patients undergoing colonoscopy for endoscopic treatment such as endoscopic polypectomy
5) Patients undergoing emergency colonoscopy for gastrointestinal bleeding
6) Patients with colonic stenosis
Target sample size
340
Research contact person
Name of lead principal investigator
| 1st name | Fumihiko |
| Middle name | |
| Last name | Nakamura |
Organization
Kohseichuo General Hospital
Division name
Digestive Disease Center
Zip code
153-8581
Address
1-11-7 Mita, Meguro-ku, Tokyo, Japan
TEL
0337132141
jymxg256@ybb.ne.jp
Public contact
Name of contact person
| 1st name | Fumihiko |
| Middle name | |
| Last name | Nakamura |
Organization
Kohseichuo General Hospital
Division name
Digestive Disease Center
Zip code
153-8581
Address
1-11-7 Mita, Meguro-ku, Tokyo, Japan
TEL
0337132141
Homepage URL
jymxg256@ybb.ne.jp
Sponsor or person
Institute
Kohseichuo General Hospital, Digestive Disease Center
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kohseichuo General Hospital
Address
1-11-7 Mita, Meguro-ku, Tokyo, Japan
Tel
0337132141
jymxg256@ybb.ne.jp
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
厚生中央病院 (東京都)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
335
Results
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
| 2022 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 24 | Day |
Last modified on
| 2025 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061128
