A Multi-center, single-blind, Randomized Controlled Trial Comparing Interrupted vs Continuous Fascial Closure in the Mini-laparotomy Incision During Laparoscopic or Robot-assisted Colorectal Resection (CLOSURE-CR trial)

未提供0 个研究点目标入组 900 人开始时间: 待定

适应症

试验速览

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•Patients who meet all of the following inclusion criteria and none of the exclusion criteria will be considered eligible for enrollment.
•Inclusion Criteria
•1.Patients with neoplastic lesions of the colon (including colorectal cancer, appendiceal tumors, neuroendocrine tumors, gastrointestinal stromal tumors, etc.) who are scheduled to undergo curative resection, and for whom laparoscopic or robot-assisted colorectal resection is planned.
•2.Patients for whom a small midline laparotomy incision including the umbilicus is planned for bowel transection, anastomosis, and specimen retrieval.
•3.Patients with an ECOG Performance Status (PS) of 0, 1, or
•4.Patients aged 18 years or older at the time of registration.
•5.Patients who are scheduled to undergo an abdominal CT scan at approximately 1 year postoperatively, or for whom such imaging is considered feasible.
•6.Patients with preserved function of major organs (including bone marrow, liver, kidney, and lungs) meeting the following criteria:
•A) White blood cell count: >=2,000mm3 and <=15,000mm3
•B) Hemoglobin: >=7.5 g/dL
•C) Platelet count: >=75,000/mm3
•D) Total bilirubin: <=2.0 mg/dL
•E) Creatinine: <=2.0 mg/dL
•7.Patients who have sufficient capacity to understand the study and have provided written informed consent.

•1.Patients with umbilical hernia or incisional abdominal wall hernia at the planned umbilical incision site, as identified on preoperative imaging.
•2.Patients scheduled to undergo emergency surgery.
•3.Patients with active infections requiring systemic treatment.
•4.Patients with a body temperature of >=38.0 degrees Celsius at the time of registration.
•5.Patients with psychiatric disorders or symptoms that interfere with daily life and are judged to make participation in the study difficult.
•6.Women who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding.
•7.Patients who are scheduled to undergo abdominal surgery within 6 months after registration (e.g., planned surgery for metastatic liver tumors as a staged resection).

发起方

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