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 2025/01/11 09:44:17

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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

Email

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


Email

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

Email

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


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

3255

Results

the records of 3,160 patients were analyzed (ICAN, n = 645; ECAN, n = 2,515). 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 who did not meet the inclusion or exclusion criteria were excluded. Finally, 1,245 patients (ICAN, n = 615; ECAN, n = 630) were included in the analysis.

Results date posted

2024 Year 06 Month 02 Day

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

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 01 Day


Other

Other related information

none


Management information

Registered date

2022 Year 06 Month 08 Day

Last modified on

2025 Year 01 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054708