A Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer

Study Overview
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Brief Summary
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The purpose of this study is to evaluate oncological outcome of patients for T3 and T4 colorectal cancer undergoing laparoscopic versus open surgery.

Detailed Description
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The benefits of laparoscopic surgery (LAP) in comparison to open surgery (OPEN) have been suggested with respect to decreased morbidity, decreased pain, faster recovery, and shorter hospital stay.1-4 However, the long-term survival of LAP for colorectal cancer is still unclear, especially for advanced colorectal cancer requiring extended lymphadenectomy. Thus, the investigators designed a study which investigates whether LAP is suitable for advanced colorectal cancer with respect to survival and post-operative morbidity.

Official Title
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Randomized Controlled Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer（JCOG 0404,CRC Surg-LAP/OPEN)

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Procedure: open colectomy
* Procedure: laparoscopic colectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven colorectal carcinoma Tumor located in the cecum, ascending colon, sigmoid colon, or rectosigmoid colon T3 or deeper lesion without involvement of other organs Without multiple lesion other than carcinoma in situ Cancer classified as N0-2 and M0, according to the TNM classification system Tumor size < 8 cm No bowel obstruction Age 20 < and > 75 years Sufficient organ function No history of gastrointestinal surgery No history of chemotherapy or radiotherapy Provided written informed consent Exclusion Criteria: Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ Severe pulmonary emphysema, interstitial pneumonitis, or ischemic heart disease Pregnant or lactating women Severe mental disease Continuous systemic steroid therapy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Procedure/Surgery: open colectomy | Procedure: open colectomy<br>* Procedure/Surgery: open colectomy<br>|
| Experimental: 2<br>Procedure/Surgery: laparoscopic colectomy | Procedure: laparoscopic colectomy<br>* Procedure/Surgery: laparoscopic colectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | During the study conduct | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse-free survival |  | During the study conduct | 
| Short-term clinical outcomes |  | time to 1st discharge after operation | 
| Adverse events |  | During the study conduct | 
| The proportion of conversion from LAP to OPEN |  | operation day | 
| The proportion of completion of LAP |  | operation day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer, laparoscopic surgery, randomized controlled trial, oncological outcome