UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062103 |
|---|---|
| Receipt number | R000071059 |
| Scientific Title | A Study on the Effects of Variations in Intraoperative Intraperitoneal Irrigation Volume on Short- and Long-Term Outcomes in Cases of Colorectal Surgery |
| Date of disclosure of the study information | 2026/07/01 |
| Last modified on | 2026/06/30 15:49:10 |
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Basic information
Public title
A Study on the Effects of Variations in Intraoperative Intraperitoneal Irrigation Volume on Short- and Long-Term Outcomes in Cases of Colorectal Surgery
Acronym
A Study on the Effects of Variations in Intraoperative Intraperitoneal Irrigation Volume on Short- and Long-Term Outcomes in Cases of Colorectal Surgery
Scientific Title
A Study on the Effects of Variations in Intraoperative Intraperitoneal Irrigation Volume on Short- and Long-Term Outcomes in Cases of Colorectal Surgery
Scientific Title:Acronym
A Study on the Effects of Variations in Intraoperative Intraperitoneal Irrigation Volume on Short- and Long-Term Outcomes in Cases of Colorectal Surgery
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
In laparoscopic surgery for colorectal diseases, intra-abdominal anastomosis has been reported to improve short-term postoperative outcomes compared to the extraperitoneal anastomosis that has been performed to date. On the other hand, there is insufficient data regarding long-term outcomes, such as the risk of postoperative infection and peritoneal seeding, associated with exposing the bowel within the abdominal cavity. Therefore, we will investigate the impact on short-term and long-term outcomes by comparing two groups: one in which intra-abdominal lavage is performed with 3 L of saline solution after anastomosis, and another in which 6 L of saline solution is used.
Basic objectives2
Others
Basic objectives -Others
Results of peritoneal lavage fluid cultures (at two time points: start and end of lavage), blood tests, and key biomarkers.
Incidence of peritoneal seeding recurrence (cancer-related markers such as CEA, CA19-9, RAS, BRAF, MSI, HER2)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Perioperative complications and long-term outcomes (3- and 5-year overall survival and recurrence-free survival)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
For patients who have undergone intraperitoneal anastomosis for colorectal cancer, perform intra-abdominal lavage with 3 L of saline solution after the anastomosis.
Interventions/Control_2
For patients who have undergone intraperitoneal anastomosis for colorectal cancer, perform intra-abdominal lavage with 6 L of saline solution after the anastomosis.
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
Patients scheduled for intraperitoneal anastomosis for colorectal cancer
Key exclusion criteria
Active multiple cancers
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Okuda |
Organization
NHO Higashihiroshima Medical Center
Division name
Department of Gastrointestinal Surgery
Zip code
739-0041
Address
513 Jike, Saijocho, Higashihiroshima City
TEL
082-423-2176
hokuda.2nd-s@go5.enjoy.ne.jp
Public contact
Name of contact person
| 1st name | Maki |
| Middle name | |
| Last name | Shinhara |
Organization
NHO Higashihiroshima Medical Center
Division name
Department of Clinical Research
Zip code
739-0041
Address
513 Jike, Saijocho, Higashihiroshima City
TEL
082-423-2176
Homepage URL
shinhara.maki.un@mail.hosp.go.jp
Sponsor or person
Institute
NHO Higashihiroshima Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
NHO Higashihiroshima Medical Center
Address
513 Jike, Saijocho, Higashihiroshima City
Tel
082-423-2176
shinhara.maki.un@mail.hosp.go.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 | 07 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2039 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 30 | Day |
Last modified on
| 2026 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071059
