UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062274 |
|---|---|
| Receipt number | R000071264 |
| Scientific Title | A Multicenter Retrospective Registry Study Investigating the Natural History of Megacolon |
| Date of disclosure of the study information | 2026/07/25 |
| Last modified on | 2026/07/18 12:28:02 |
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Basic information
Public title
A Multicenter Retrospective Registry Study Investigating the Natural History of Megacolon
Acronym
A Registry Study Investigating the Natural History of Megacolon
Scientific Title
A Multicenter Retrospective Registry Study Investigating the Natural History of Megacolon
Scientific Title:Acronym
A Multicenter Retrospective Registry Study Investigating the Natural History of Megacolon
Region
| Japan |
Condition
Condition
Megacolon
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To comprehensively characterize the natural history, treatment patterns, and outcomes of megacolon using a multicenter retrospective registry, and to investigate clinical characteristics associated with the risk of disease progression and treatment selection.
Basic objectives2
Others
Basic objectives -Others
To characterize the natural history, treatment patterns, and outcomes of megacolon and to investigate clinical characteristics associated with disease progression and treatment selection.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time from the date of diagnosis of megacolon, or the date of the first megacolon-related visit when the date of diagnosis cannot be determined, to the first occurrence of a major clinical event, defined as colectomy, stoma creation, intestinal perforation, volvulus, bowel obstruction, other surgical intervention, or all-cause death.
Key secondary outcomes
1. Time from diagnosis or the first megacolon-related visit to colectomy, stoma creation, intestinal perforation, volvulus, bowel obstruction, other surgery, or all-cause death, and the incidence of each event at 1, 3, 5, and 10 years.
2. Time from symptom onset to diagnosis, the first visit, and the first major clinical event.
3. Time to colectomy and the proportion undergoing colectomy.
4. Time to stoma creation and the proportion undergoing stoma creation.
5. Number and duration of megacolon-related hospitalizations and hospitalization rate per person-year.
6. Maximum colonic diameter on CT at diagnosis or the first visit, its longitudinal change, and its association with major clinical events.
7. Cutoff value of maximum colonic diameter for predicting major clinical events, colectomy, or death.
8. Frequency of abdominal distension, abdominal pain, constipation, bowel movements, nausea, vomiting, poor oral intake, weight loss, bowel obstruction, volvulus, perforation, and respiratory or circulatory compromise.
9. Age, sex, height, weight, BMI, estimated onset, presumed etiology, comorbidities, medical, surgical and family history, and concomitant medications.
10. Red blood cell count, hemoglobin, white blood cell count, platelet count, PT, PT-INR, bilirubin, AST, ALT, GGT, blood urea nitrogen, creatinine, albumin, HbA1c, glucose, lipids, C-reactive protein, and electrolytes.
11. Types, timing, and frequency of laxatives, prokinetics, enemas, manual disimpaction, transanal or endoscopic decompression, nutritional therapy, and surgery.
12. Changes in symptoms, imaging findings, and hospitalization frequency before treatment, at the first post-treatment assessment, and at 6 and 12 months.
13. Major clinical events, treatments, and outcomes according to presumed etiology.
14. Associations of patient characteristics, symptoms, laboratory findings, maximum colonic diameter, and treatments with major clinical events.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who visited a participating institution during the study period and were diagnosed with megacolon based on medical records and imaging findings, including abdominal radiography or computed tomography.
2. Patients with available medical record data on clinical characteristics at diagnosis or the first megacolon-related visit, treatments, and clinical outcomes.
Key exclusion criteria
1. Patients in whom the diagnosis of megacolon cannot be confirmed from medical records or imaging findings.
2. Patients with insufficient data to evaluate the date of diagnosis, clinical characteristics at the first visit, treatments, or major clinical outcomes.
3. Duplicate records of the same patient.
4. Patients who declined participation in the study.
5. Patients considered inappropriate for inclusion by the principal investigator or participating investigators.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takaomi |
| Middle name | |
| Last name | Kessoku |
Organization
International University of Health and Welfare Narita Hospital
Division name
Department of Palliative Medicine
Zip code
286-0124
Address
852, Hatakeda, Narita, Chiba, Japan
TEL
+81476-35-5600
kessoku-tho@umin.ac.jp
Public contact
Name of contact person
| 1st name | Takaomi |
| Middle name | |
| Last name | Kessoku |
Organization
International University of Health and Welfare Narita Hospital
Division name
Department of Palliative Medicine
Zip code
286-0124
Address
852, Hatakeda, Narita, Chiba, Japan
TEL
+81476-35-5600
Homepage URL
kessoku-tho@umin.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Takaomi Kessoku
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
International University of Health and Welfare Chiba District Ethics Review Committee
Address
852, Hatakeda, Narita, Chiba, Japan
Tel
+81476-20-7708
rinri_md@iuhw.ac.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
国際医療福祉大学成田病院（千葉県）、川崎医科大学総合医療センター（岡山県）、埼玉医科大学病院（埼玉県）、岩手医科大学附属内丸メディカルセンター（岩手県）、日本医科大学武蔵小杉病院（神奈川県）、帝京大学医学部附属病院（東京都）、慶應義塾大学病院（東京都）、さがみ林間病院（神奈川県）、国立国際医療センター（東京都）、済生会福岡総合病院（福岡県）、製鉄記念室蘭病院（北海道）、福島県立医科大学附属病院（福島県）、九州大学病院（福岡県）、国立病院機構西埼玉中央病院（埼玉県）、順天堂大学医学部附属順天堂医院（東京都）、横浜市立大学附属病院（神奈川県）、川崎市立川崎病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter retrospective cohort study. No study-specific intervention, allocation, or additional examination will be performed.
Management information
Registered date
| 2026 | Year | 07 | Month | 18 | Day |
Last modified on
| 2026 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071264
