Multivisceral Radical Resection for Surgical T4b Colorectal Cancer: Propensity Score-matched Study Comparing the the Laparoscopic and Open Approaches

Study Overview
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Brief Summary
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This study attempts to compare safety and long-term oncological outcomes between laparoscopic surgery and open surgery in the treatment of clinical T4b Colorectal cancer.

Detailed Description
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Laparoscopic surgery is controversial for patients with T4b colorectal cancer who require multivisceral resection. With the expansion of the indications for laparoscopic surgery in recent years, surgeons try to perform laparoscopic multivisceral resection for the treatment of clinical T4b colorectal cancer. In this study, investigators attempted to compare safety and long-term oncological outcomes between laparoscopic surgery and open surgery in the treatment of clinical T4b colorectal cancer. This study was a multicenter retrospective cohort study based on a multicenter database which contained hospitalization. According to the operation method, the patients were divided into laparoscopic multivisceral resection group(patients who underwent laparoscopic surgery or conversion to open surgery) and open multivisceral resection group(patients who underwent open surgery directly). The short-term and long-term result was compared between groups.

Official Title
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Multivisceral Radical Resection for Surgical T4b Colorectal Cancer: Propensity Score-matched Study Comparing the the Laparoscopic and Open Approaches

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Procedure: Laparoscopic surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient was pathologically diagnosed as colorectal adenocarcinoma by endoscopic biopsy before operation. All patients were considered to have tumors invading adjacent organs after preoperative radiographic evaluation. All patients were recommended to undergo radical surgery after preoperative multidisciplinary consultation. Exclusion Criteria: Patients with distant metastasis or recurrent colorectal cancer were excluded.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Laparoscopic multivisceral resection group<br>Patients who underwent laparoscopic multivisceral resection for clinical T4b colorectal cancer | Procedure: Laparoscopic surgery<br>* The laparoscopic approach was used for the treatment of clinical T4b colorectal cancer<br>|
| Open multivisceral resection group<br>Patients who underwent open multivisceral resection for clinical T4b colorectal cancer | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss | Blood loss is defined as intraoperative blood loss and measured in milliliters(ml). | Until the end of the operation, an average of 8 hours. | 
| Complications | Complications are defined as all surgery-related adverse events postoperatively, such as anastomotic leak, infection, which are measured in frequency. | Until the patient recovered and was discharged from the hospital, an average of 10 days. | 
| Hospital stay after surgery | Hospital stay after surgery is defined as the length of time from the end of surgery to the discharge of patient, which is measured in days. | Until the patient recovered and was discharged from the hospital, an average of 10 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival is defined as the time from the surgery to death or last follow-up, regardless of disease recurrence, which was measured in months. | The endpoint of the overall survival assessment is the last follow-up or patient death. Follow-up time is up to 72 months. | 
| Disease-free survival | Disease-free survival is defined as the time from the surgery to disease recurrence or last follow-up, which was measured in months. | The endpoint of the disease-free survival assessment is the last follow-up or disease recurrence. Follow-up time is up to 72 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal cancer, Multivisceral resection, Laparoscope