UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059217 |
|---|---|
| Receipt number | R000067723 |
| Scientific Title | A Prospective Study on the Safety and Efficacy of End-to End Delta-Shaped Anastomosis in Crohn's Disease Patients Undergoing Intestinal Resection |
| Date of disclosure of the study information | 2026/01/01 |
| Last modified on | 2025/11/23 22:22:54 |
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Basic information
Public title
A Prospective Study on the Safety and Efficacy of End-to End Delta-Shaped Anastomosis in Crohn's Disease Patients Undergoing Intestinal Resection
Acronym
C-TRIAD study (Crohn's-Triangulating Anastomosis Design study)
Scientific Title
A Prospective Study on the Safety and Efficacy of End-to End Delta-Shaped Anastomosis in Crohn's Disease Patients Undergoing Intestinal Resection
Scientific Title:Acronym
C-TRIAD study (Crohn's-Triangulating Anastomosis Design study)
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In patients undergoing intestinal resection for Crohn's disease, this study aims to establish an "easy, safe, and universally applicable anastomotic technique" by adopting a stapled end-to-end delta shaped anastomosis. Specifically, the objective is to clarify the incidence of anastomotic leakage, the rate of endoscopic recurrence at the anastomotic site, and the reoperation rate associated with this simple and technically less operator-dependent procedure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of anastomotic leakage (all grades according to the Clavien-Dindo classification)
Key secondary outcomes
Incidence of perioperative complications (all grades according to the Clavien-Dindo classification), Anastomosis time, Intraoperative blood loss, Operative time, Postoperative length of hospital stay, Endoscopic recurrence rate at 1 year postoperatively, Clinical recurrence rate at 1 and 5 years postoperatively, Reoperation rate at 5 years postoperatively
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Delta shaped anastomosis
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
| 16 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients aged 16 years or older at the time of informed consent
Performance Status (ECOG) of 0-2
Patients diagnosed with Croh's disease who are scheduled to undergo intestinal resection and anastomosis, regardless of the number of prior surgeries, surgical approach (open/laparoscopic), or disease phenotype (stricturing/penetrating)
Patients not scheduled for proximal stoma construction at the anastomotic site
Patients who have provided written informed consent to participate in this study
Key exclusion criteria
Malignant disease
Patients in whom a discrepancy of more than twofold in bowel lumen diameter
Patients in whom intraoperative findings indicated that bowel anastomosis was inappropriate or a proximal stoma was deemed necessary
Emergency surgery for bleeding, perforation, or other acute conditions
Malnutrition due to prolonged fasting
Pregnant or lactating women, or women who are pregnant or intend to become pregnant
Patients judged by the principal or sub-investigator to be inappropriate for inclusion in this study
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Mitsuro |
| Middle name | |
| Last name | Kanda |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
TEL
052-744-2249
kanda.mitsuro.v5@f.mail.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Norifumi |
| Middle name | |
| Last name | Hattori |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
TEL
052-744-2249
Homepage URL
hattori.norifumi.v1@f.mail.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine,
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Gastrointestinal and Pediatric Surgery Mie University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Certified Review Board
Address
Tsurumai-cho 65, Showa-ku, Nagoya, Aichi
Tel
052-744-2479
ethics@med.nagoya-u.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 | 01 | Month | 01 | 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
| 2025 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2033 | Year | 06 | Month | 30 | 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 | 09 | Month | 27 | Day |
Last modified on
| 2025 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067723
