Clinical Trial: A Study on the Effects of Variations in Intraoperative Intraperitoneal Irrigation Volume on Short- and Long-Term Outcomes in Cases of Colorectal Surgery (Japan)

Tokyo, July 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062103) titled 'A Study on the Effects of Variations in Intraoperative Intraperitoneal Irrigation Volume on Short- and Long-Term Outcomes in Cases of Colorectal Surgery' on July 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - NHO Higashihiroshima Medical Center

Condition: Condition - Colorectal cancer Classification by malignancy - Malignancy Genomic information - YES

Objective: 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

Intervention: 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.

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 Size - 400

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071059

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