Safety Study of Transumbilical Single Incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer

Study Overview
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Brief Summary
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Compared with traditional open colectomy, laparoscopic surgery is associated with less pain, earlier recovery, and better cosmetic outcome, and its short- and long-term oncologic outcomes have been demonstrated. In experienced surgeons' hands, single incision laparoscopic surgery is increasingly performed for colorectal disease, and even for malignant lesion because of its reduced incision-associated morbidity and scarring. However, the safety and efficacy of single incision laparoscopic surgery for colorectal cancer has not yet been evaluated. Thus, the prospective randomized trial comparing single incision versus conventional laparoscopic surgery for colorectal cancer is needed.

Official Title
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A Prospective Randomized Controlled Trial Comparing Transumbilical Single Incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Procedure: Single incision laparoscopic surgery
* Procedure: Conventional laparoscopic surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years < age < 80 years Tumor located in rectosigmoid (defined as 10- to 30-cm from the anal verge) Pathological rectosigmoid carcinoma Preoperative T stage ranging from T1 to T4a according to the 7th Edition of AJCC Cancer Staging Manual Tumor size of 5 cm or less; 6) ECOG score is 0-1 ASA socre is Ⅰ-Ⅲ Informed consent Exclusion Criteria: Body mass index (BMI) >30 kg/m2 Pregnant woman or lactating woman Severe mental disease Previous abdominal surgery Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer Requirement of simultaneous surgery for other disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Experimental: Single incision laparoscopic surgery<br>Transumbilical single incision laparoscopic surgery will be performed for patients in this group.And addition of only one trocar through the stoma for drainage tube is allowed. | Procedure: Single incision laparoscopic surgery<br> <br> * Other names: SILS;|
| Active Comparator: Conventional laparoscopic surgery<br>Conventional laparoscopic surgery for colorectal cancer will be performed for patients in this group. | Procedure: Conventional laparoscopic surgery<br> <br> * Other names: CLS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early morbidity rate | The early morbidity rate is defined as the event observed during operation and within 30 days after surgery, | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative outcomes | Operative time, estimated blood loss and incision length are recorded. | intraoperative | 
| Pathological outecomes | Tumor size, length of proximal and distal margin and lymph nodes harvested are used to assess oncological resection. | 5 days | 
| Postoperative recovery course | Time to first ambulation, flatus, liquid diet, soft diet, and duration of hospital stay are used to assess the postoperative recoverty course. | 14 days | 
| Pain score | Postoperative pain is recorded using the visual analog scale (VAS) pain score tool on postoperative day 1, 2, 3 and the day of discharge. | 14 days | 
| Cosmetic assessment | Cosmetic assessment is perform using body image scale and cosmetic scale. | 14 days | 
| 3-year disease free survival rate |  | 36 months | 
| 5-year overall survival rate |  | 60 months | 
| Inflammatory and immune response |  | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Single-incision, Laparoscopy, Colorectal Cancer