UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056802 |
|---|---|
| Receipt number | R000064921 |
| Scientific Title | Delayed Versus Immediate Coloanal Anastomosis Following Total Mesorectal Excision for Low Rectal Cancer: An International Multicenter Retrospective Cohort Study |
| Date of disclosure of the study information | 2025/01/24 |
| Last modified on | 2025/01/24 08:20:33 |
* 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
Delayed Versus Immediate Coloanal Anastomosis Following Total Mesorectal Excision for Low Rectal Cancer: An International Multicenter Retrospective Cohort Study
Acronym
DCAA vs ICAA
Scientific Title
Delayed Versus Immediate Coloanal Anastomosis Following Total Mesorectal Excision for Low Rectal Cancer: An International Multicenter Retrospective Cohort Study
Scientific Title:Acronym
DCAA vs ICAA
Region
| Japan | Asia(except Japan) |
Condition
Condition
Low Rectal Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare postoperative outcomes between DCAA and ICAA following elective total mesorectal excision (TME) for low rectal cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the 30-day overall postoperative complication rate
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
Patients 18 years or older of age who underwent minimally invasive TME with hand-sewn coloanal anastomosis for primary low rectal adenocarcinoma between January 2017 and July 2023
Key exclusion criteria
Tumor-related exclusion criteria included recurrent tumors, multiple primary tumors, and non-adenocarcinomas such as neuroendocrine tumors and gastrointestinal stromal tumors. The procedure-related exclusion criteria included open surgery, emergency surgery, and multivisceral resection/pelvic exenteration. Stapled coloanal anastomosis, DCAA with a diverting stoma, and ICAA without a diverting stoma were also excluded.
Target sample size
305
Research contact person
Name of lead principal investigator
| 1st name | Isaac |
| Middle name | |
| Last name | Seow-En |
Organization
Singapore General Hospital
Division name
Department of Colorectal Surgery
Zip code
169608
Address
Outram Road, 169608, Singapore
TEL
+65-6222-3322
isaac.seow.en@gmail.com
Public contact
Name of contact person
| 1st name | Isaac |
| Middle name | |
| Last name | Seow-En |
Organization
Singapore General Hospital
Division name
Department of Colorectal Surgery
Zip code
169608
Address
Outram Road, 169608, Singapore
TEL
+65-6222-3322
Homepage URL
isaac.seow.en@gmail.com
Sponsor or person
Institute
Singapore General Hospital
Institute
Department
Personal name
Funding Source
Organization
self-procurement
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Singapore General Hospital
Address
Outram Road, 169608, Singapore
Tel
+65-6222-3322
isaac.seow.en@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
| 2025 | Year | 01 | 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
305
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
| 2024 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2025 | Year | 01 | Month | 24 | Day |
Last modified on
| 2025 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064921
