Colorectal cancer (adenocarcinoma, mucinous carcinoma, signet-ring cell carcinoma, and adenosquamou) Colorectal cancer
Conditions
Interventions
Randomized to a method of suture.
Colorectal cancer ,Continuous suture, Interrupted suture , Incisional hernia
Sponsors
Yamakawa Yushi
Eligibility
Inclusion criteria
Inclusion criteria: 1. The specimen will be retrieved through a midline incision during robotic or laparoscopic surgery. 2. Histological diagnosis of primary colorectal cancer (adenocarcinoma, mucinous carcinoma, signet-ring cell carcinoma, or adenosquamous carcinoma) has been confirmed by endoscopic biopsy. 3. The Eastern Cooperative Oncology Group (ECOG) Performance Status is 0, 1, or 2. 4. The patient is between 20 and 80 years old, inclusive, on the day of registration. 5. The patient is scheduled for elective surgery. 6. No plan for a colostomy. 7. No history of prior chemotherapy or radiation therapy. 8. Written informed consent has been obtained from the patient after a thorough explanation of the study.
Exclusion criteria
Exclusion criteria: 1. The patient has one or more of the following serious complications: -Systemic infection requiring treatment. -Fever of 38.0 degree or higher at the time of registration. -Ongoing systemic administration of steroids or other immunosuppressive drugs (oral or intravenous). -Uncontrolled diabetes mellitus. -Unstable angina (new onset or worsening within the last 3 weeks) or a history of myocardial infarction within the last 6 months. -Uncontrolled valvular disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy. 2. The patient has peritoneal dissemination. 3. The patient has a history of a midline abdominal incision and currently has or has a history of an incisional hernia. Note: A history of a midline abdominal incision alone is not an exclusion criterion. 4. The patient has a mental illness or psychiatric symptoms that interfere with daily life and are deemed to make participation in the study difficult. 5. The patient is pregnant or has a possibility of being pregnant. 6. Other reasons determined by the principal investigator (or sub-investigator) that make the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of incisional hernia after mini-laparotomy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.We will collect and summarize the distribution of data for the intraoperative and early postoperative course by randomized group, including operative time, fascial closure time, length of the mini-laparotomy incision, length and number of sutures used (for continuous and interrupted sutures, respectively), suture bite length, suture pitch interval, blood loss, days until first flatus or bowel movement, date of diet initiation, use of analgesics, and postoperative hospital stay. 2.We will evaluate the rate of surgical complications, specifically: -Intraoperative complication rate (from the start of the surgery to the end of the surgery [wound closure]) -Early postoperative complication rate (from the end of the surgery [wound closure] to within 30 days post-op) -Late postoperative complication rate (from 31 days to 1.5 years post-op) 3.We will calculate the re-hospitalization rate within 90 days post-operation due to postoperative complications, along with its 95% confidence interval, for each randomized group. Additionally, we will calculate the odds ratio and its 95% confidence interval for the continuous suture group versus the interrupted suture group. | — |
Countries
Japan, No
Contacts
Public ContactYushi Yamakawa
Nagoya City University Hospital
Outcome results
None listed