UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057780 |
|---|---|
| Receipt number | R000066037 |
| Scientific Title | Evaluating the Need for Restrictions After Cold Snare Polypectomy |
| Date of disclosure of the study information | 2025/05/05 |
| Last modified on | 2025/05/05 19:52:55 |
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Basic information
Public title
Evaluating the Need for Restrictions After Cold Snare Polypectomy
Acronym
Evaluating the Need for Restrictions After Cold Snare Polypectomy
Scientific Title
Evaluating the Need for Restrictions After Cold Snare Polypectomy
Scientific Title:Acronym
Evaluating the Need for Restrictions After Cold Snare Polypectomy
Region
| Japan |
Condition
Condition
colonic polyps
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This prospective single-arm study investigates whether forgoing restrictions on diet, exercise, and alcohol intake after cold snare polypectomy affects the incidence of adverse events.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
incidence of adverse events
Key secondary outcomes
Risk factors for the development of adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants in this study will not be subject to the conventional activity restrictions typically imposed after colorectal polypectomy and will be allowed to go about their daily lives without limitation.
Traditional activity restrictions include:
Diet (including alcohol):
Avoid alcohol, caffeine, spicy foods (such as chili peppers and carbonated drinks), greasy foods (such as meat, fried foods, and ramen), and raw foods for one week.
Exercise:
Light activities such as walking may be resumed from the day after the procedure. However, activities that increase abdominal pressure (e.g., golf, tennis, jogging) should be avoided for one week.
Bathing:
Showering is allowed for the first week. Full bathing (e.g., soaking in a tub) is permitted after one week, but prolonged immersion should be avoided.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inclusion Criteria:
Age 20 years or older at the time of enrollment.
ECOG performance status of 0 or 1.
Laboratory values within 30 days prior to enrollment meet all of the following (no blood transfusion within 14 days prior to the labs used for enrollment):
a. Hemoglobin equal to or greater than 9 g/dL
b. Platelet count equal to or greater than 100000/mm3
c. AST and ALT less than or equal to 100 IU/L
d. Serum creatinine less than or equal to 2.0 mg/dL
Ability to be followed for 30 days post-procedure.
Written informed consent obtained for participation in the study.
An adult cohabitant must be present in the participant's household, and the participant must be able to visit the hospital within 2 hours if necessary.
Key exclusion criteria
Exclusion Criteria:
History of endoscopic treatment for lower gastrointestinal lesions within 30 days prior to enrollment.
Planned endoscopic treatment for the lower gastrointestinal tract within 30 days after enrollment.
Women who are pregnant, possibly pregnant, or breastfeeding.
Patients with psychiatric disorders that impair their ability to fully understand the study.
History of myocardial infarction or unstable angina within the past 3 months.
Known coagulation disorders.
Active bacterial or fungal infections, defined as a body temperature of 38.5 degrees Celsius or higher with radiological or microbiological evidence of infection.
Respiratory diseases requiring continuous oxygen therapy.
Patients undergoing dialysis.
Uncontrolled hypertension.
Any case deemed unsuitable for participation in the study by the attending physician.
Sporadic localized tumors or dysplasia-associated lesions or masses (DALMs) associated with chronic inflammation such as ulcerative colitis.
Lesions with local residual disease after previous endoscopic resection or those located at postoperative anastomotic sites.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Ohata |
Organization
NTT Medical Center Tokyo
Division name
Department of Gastrointestinal Endoscopy
Zip code
141-0022
Address
5 Chome-9-22 Higashigotanda, Shinagawa City, Tokyo
TEL
03-3448-6111
ken.ohata1974.@gmail.com
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Nagae |
Organization
NTT Medical Center Tokyo
Division name
Department of Gastrointestinal Endoscopy
Zip code
141-0022
Address
5 Chome-9-22 Higashigotanda, Shinagawa City, Tokyo
TEL
08017130579
Homepage URL
shinyanagae1993@gmail.com
Sponsor or person
Institute
NTT Medical Center Tokyo
Institute
Department
Personal name
Funding Source
Organization
None
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
NTT Medical Center Tokyo Ethics Committee
Address
5 Chome-9-22 Higashigotanda, Shinagawa City, Tokyo
Tel
03-3448-6111
shinyanagae1993@gmail.com
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
NTT東日本関東病院, 大森赤十字病院, 大牟田市立病院, 板橋中央総合病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 05 | 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
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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2026 | 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 | 05 | Month | 05 | Day |
Last modified on
| 2025 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066037
