UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047994 |
|---|---|
| Receipt number | R000054708 |
| Scientific Title | Short- and long-term outcome of intracorporeal anastomosis in laparoscopic colectomy for colon cancer: Multi-center retro and prospective cohort study |
| Date of disclosure of the study information | 2022/06/09 |
| Last modified on | 2026/06/11 14:10:35 |
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Basic information
Public title
Short- and long-term outcome of intracorporeal anastomosis in laparoscopic colectomy for colon cancer:
Multi-center retro and prospective cohort study
Acronym
Ican study
Scientific Title
Short- and long-term outcome of intracorporeal anastomosis in laparoscopic colectomy for colon cancer:
Multi-center retro and prospective cohort study
Scientific Title:Acronym
Ican study
Region
| Japan |
Condition
Condition
Colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and usefulness of intracorporeal anastomosis by comparing the short-term and long-term results with that of extracorporeal anastomosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
3-year relapse free survival
Key secondary outcomes
3-year overall survival, 3-year local, peritoneal and anastomotic site recurrence free survival, Incidence of postoperative complications, length of surgical incision, portion of surgical wound, length of surgical specimen (PM, DM), operation time, blood loss, number of harvested lymph nodes, anastomotic method, open conversion rate, conversion rate to extracorporeal anastomosis, time to bowel movement, hospital stay period after surgery, operation results according to colon region
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who are histologically diagnosed with colon adenocarcinoma before surgery
2) Patients diagnosed with Stage 0-III by preoperative clinical diagnosis
3) Patients with Grade 0 to 2 general status of ECOG Performance Status
4) R0 surgical cases
Key exclusion criteria
1) Patients who have had a large intestine (colon, rectum) resection in the past
2) Patients who underwent anastomosis with Double Stapling Technique
3) Patients who have a stoma
4) Patients with intestinal obstruction
5) Patients undergoing emergency surgery
6) Patients who received preoperative chemotherapy
Target sample size
5500
Research contact person
Name of lead principal investigator
| 1st name | SangWoong |
| Middle name | |
| Last name | LEE |
Organization
Osaka medical and pharmaceutical university
Division name
Genaral and gastroenterological surgery
Zip code
5698686
Address
2-7 Daigakumachi Takatsuki-shi Osaka Japan
TEL
+81(0)72-683-1221
keitaro.tanaka@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Keitaro |
| Middle name | |
| Last name | Tanaka |
Organization
Otsu city hospital
Division name
Genaral, breast and gastroenterological surgery
Zip code
520-0804
Address
2-9-9 Motomiya Otsu-shi Shiga Japan
TEL
+81(0)77-522-4607
Homepage URL
keitaro.tanaka@ompu.ac.jp
Sponsor or person
Institute
Osaka medical and pharmaceutical university
Genaral and gastroenterological surgery
Institute
Department
Personal name
Funding Source
Organization
Osaka medical and pharmaceutical university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japan society of laparoscopic colorectal surgery
Name of secondary funder(s)
Japan society of laparoscopic colorectal surgery
IRB Contact (For public release)
Organization
Ethics Committee of Osaka Medical and Pharmaceutical University
Address
2-7 Daigakumachi Takatsuki-shi Osaka Japan
Tel
0726831221
rinri@ompu.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
| 2022 | Year | 06 | Month | 09 | Day |
Related information
URL releasing protocol
doi: 10.1002/ags3.12915
Publication of results
Partially published
Result
URL related to results and publications
DOI: 10.1002/ags3.12915
Number of participants that the trial has enrolled
3160
Results
Intracorporeal anastomosis showed advantages over extracorporeal anastomosis in terms of blood loss, intraoperative vascular injury (potentially), bowel recovery, and length of hospital stay, despite the longer operative time.
Results date posted
| 2024 | Year | 06 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 01 | Month | 11 | Day |
Baseline Characteristics
This multicenter retrospective cohort study involved 46 institutions in Japan belonging to the Japan Society for Laparoscopic Colorectal Surgery (JSLCS).
Participant flow
Between January 2020 and December 2021, 3255 patients were assessed for eligibility; 95 were excluded from the study. Therefore, the records of 3160 patients were analyzed (ICAN, n = 645; ECAN, n = 2515). After PSM, 641 matched patients were included in each of the ICAN and ECAN groups. Perioperative and pathological data were assessed, and after data cleaning, 37 patients were excluded. Finally, 1245 patients (ICAN, n = 615; ECAN, n = 630) were included in the analysis
Adverse events
none
Outcome measures
For each patient, the records analyzed included the clinical characteristics, surgical data, postoperative outcomes, and pathological outcomes. Baseline patient characteristics comprised age, sex, body mass index, American Society of Anesthesiologists classification, comorbidities, previous abdominal surgery, tumor location, and tumor stage.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 09 | Month | 30 | Day |
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 06 | Month | 08 | Day |
Last modified on
| 2026 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054708
