UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062529 |
|---|---|
| Receipt number | R000071575 |
| Scientific Title | Changes in Anorectal Function and Defecatory Dysfunction Before and After Temporary Stoma Closure Following Rectal Cancer Surgery After Neoadjuvant Chemoradiotherapy: A Prospective Interventional Study |
| Date of disclosure of the study information | 2026/08/10 |
| Last modified on | 2026/08/09 18:31:08 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Changes in Anorectal Function and Defecatory Dysfunction Before and After Temporary Stoma Closure Following Rectal Cancer Surgery After Neoadjuvant Chemoradiotherapy
Acronym
NeoAF Study
Scientific Title
Changes in Anorectal Function and Defecatory Dysfunction Before and After Temporary Stoma Closure Following Rectal Cancer Surgery After Neoadjuvant Chemoradiotherapy: A Prospective Interventional Study
Scientific Title:Acronym
NeoAF Study
Region
| Japan |
Condition
Condition
Rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to prospectively evaluate changes in anorectal function and defecatory dysfunction before and after temporary stoma closure in patients who have undergone rectal cancer surgery with temporary stoma creation following neoadjuvant therapy. Changes in objective anorectal function, bowel function, and quality of life before and after stoma closure will be assessed using anorectal manometry, defecography, and patient-reported questionnaires.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of major low anterior resection syndrome (LARS) at 6 months after stoma closure
Key secondary outcomes
Changes in the incidence and severity of low anterior resection syndrome (LARS), anorectal function, and quality of life (QOL) before and after temporary stoma closure
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Anorectal manometry, defecography, and questionnaire assessments will be performed before and after temporary stoma closure.
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
Patients who meet all of the following eligibility criteria will be considered eligible:
1. Patients who have undergone sphincter-preserving rectal resection with temporary ileostomy for rectal cancer following neoadjuvant therapy.
2. Patients scheduled for temporary stoma closure within 3 months to 1 year after rectal resection.
3. Patients confirmed by colonoscopy to have no abnormal findings, such as anastomotic stricture or ulceration.
4. Patients aged 20 years or older at the time of informed consent.
5. Patients who have provided written informed consent voluntarily after receiving an explanation of the study using the written informed consent document.
Key exclusion criteria
Patients meeting any of the following criteria will be excluded:
1. Patients who are unable to complete the questionnaires or undergo anorectal function testing due to dementia, psychiatric disorders, or other conditions.
2. Patients who do not wish to undergo temporary stoma closure.
3. Patients with an allergy to barium or wheat flour.
4. Patients whom the principal investigator considers unsuitable for participation in the study for safety reasons.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Itano |
Organization
International University of Health and Welfare Narita Hospital
Division name
Department of Hepato-Biliary-Pancreatic and Gastrointestinal Surgery
Zip code
286-8520
Address
852 Hatakeda, Narita, Chiba
TEL
0476-35-5600
itano@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Ami |
| Middle name | |
| Last name | Nishijima |
Organization
International University of Health and Welfare Narita Hospital
Division name
Department of Hepato-Biliary-Pancreatic and Gastrointestinal Surgery
Zip code
286-8520
Address
852 Hatakeda, Narita, Chiba
TEL
0476-35-5600
Homepage URL
anishijima@ihwg.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
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
Institutional review board, International University of Health and Welfare
Address
852 Hatakeda, Narita, Chiba
Tel
0476-35-5600
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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 10 | 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 | 07 | Month | 22 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2027 | Year | 07 | 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
| 2026 | Year | 08 | Month | 09 | Day |
Last modified on
| 2026 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071575
