UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062113 |
|---|---|
| Receipt number | R000071075 |
| Scientific Title | Patient Satisfaction and Quality of Life After Low Anterior Resection Versus Permanent Stoma for Lower Rectal Cancer: A Comparative Study |
| Date of disclosure of the study information | 2026/08/31 |
| Last modified on | 2026/07/02 01:22:01 |
* 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
Patient Satisfaction and Quality of Life After Low Anterior Resection Versus Permanent Stoma for Lower Rectal Cancer: A Comparative Study
Acronym
Patient Satisfaction and Quality of Life After Low Anterior Resection Versus Permanent Stoma for Lower Rectal Cancer: A Comparative Study
Scientific Title
Patient Satisfaction and Quality of Life After Low Anterior Resection Versus Permanent Stoma for Lower Rectal Cancer: A Comparative Study
Scientific Title:Acronym
Patient Satisfaction and Quality of Life After Low Anterior Resection Versus Permanent Stoma for Lower Rectal Cancer: A Comparative Study
Region
| Japan |
Condition
Condition
Lower Rectal Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to compare postoperative patient satisfaction and quality of life using questionnaire surveys between patients with rectal cancer who underwent low anterior resection and achieved stoma-free status and those with a permanent stoma following abdominoperineal resection or Hartmann's procedure, thereby clarifying the characteristics of each surgical approach from the patient's perspective.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient satisfaction assessment, EORTC QLQ-CR29, and the LARS score
Key secondary outcomes
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 provided written informed consent
2.Patients with clinical stage I-III rectal adenocarcinoma
3.Patients who underwent LAR, super-low anterior resection (SLAR), intersphincteric resection (ISR), abdominoperineal resection (APR), or Hartmann's procedure
4.In the LAR group, patients for whom at least 3 months have elapsed since stoma closure
5.In the permanent stoma group, patients for whom at least 1 month has elapsed since surgery
6.Patients who are able to complete the questionnaire
7.Patients aged 18 years or older
Key exclusion criteria
1. Patients with multiple primary cancers, either synchronous or metachronous, with a disease-free interval of <=5 years
2. Patients with recurrent rectal cancer
3. Patients with an active infection
4. Patients with a history of psychiatric disorders and/or central nervous system disorders
5. Patients who are pregnant, breastfeeding, or may be pregnant
6. Patients with severe comorbidities, including cardiopulmonary dysfunction, renal failure, paralytic ileus, bowel obstruction, uncontrolled diabetes mellitus, liver cirrhosis, chronic hepatitis B, or chronic hepatitis C
7. Patients with a history of organ transplantation
8. Patients who are unable to complete the questionnaire because of cognitive impairment or other reasons
9. Patients considered unsuitable for study enrollment by the investigators
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Nozomi |
| Middle name | |
| Last name | Yamazaki |
Organization
Saitama Medical University International Medical Center
Division name
Department of Gastrointestinal Surgery
Zip code
350-1298
Address
1397-1 Yamane, Hidaka, Saitama 350-1298, Japan
TEL
042-984-4111
nozomi.ito.1031@gmail.com
Public contact
Name of contact person
| 1st name | Yamazaki |
| Middle name | |
| Last name | Nozomi |
Organization
Saitama Medical University International Medical Center
Division name
Department of Gastrointestinal Surgery
Zip code
350-1298
Address
1397-1 Yamane, Hidaka, Saitama 350-1298, Japan
TEL
042-984-4111
Homepage URL
nozomi.ito.1031@gmail.com
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
No
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
Saitama Medical University International Medical Center
Address
Saitama Medical University International Medical Center
Tel
042-984-4111
nozomi.ito.1031@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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center retrospective observational study.
The aim of this study is to compare patient satisfaction and quality of life between the LAR group and the permanent stoma group.
The primary endpoint is the assessment of postoperative patient satisfaction and quality of life using questionnaires.
Management information
Registered date
| 2026 | Year | 07 | Month | 02 | Day |
Last modified on
| 2026 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071075
