Single Incision Laparoscopic Colorectal Surgery

Study Overview
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Brief Summary
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Single incision laparoscopic surgery (SILS) is the further development of the concept of minimally invasive surgery for colorectal cancer,which rapidly developed in the field of colorectal surgery. Through the development of single hole laparoscopic colorectal cancer radical surgery and clinical study and follow up accordingly, evaluating the feasibility, surgical effectiveness and economy help to promote the popularization and application of single hole laparoscopic techniques in the field.

Detailed Description
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The patients with colorectal cancer will randomly divided into single incision laparoscopic surgery group and conditional laparoscopic surgery group. The operation time, blood loss, the incidence of lymph node , the number of postoperative complications, the gastrointestinal function recovery time, postoperative hospital stay，the number of local recurrence and distant metastasis, survival rate and the total cost of hospitalization will be evaluated to confirm the feasibility of single incision laparoscopic surgery is effective and economical. It is worthy of clinical application.

Official Title
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Single Incision Laparoscopic Surgery (SILS) for Colorectal Disease

Conditions
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Laparoscopic Colorectal Surgery

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 colon and high rectum ( the lower border of the tumor is above the peritoneal reflection) Pathological colorectal carcinoma Clinically diagnosed cT1-4aN0-2 M0 lesions according to the 7th Edition of AJCC Cancer Staging Manual Tumor size of 5 cm or less ECOG score is 0-1 ASA score is Ⅰ-Ⅲ Informed consent Exclusion Criteria: Body mass index (BMI) >30 kg/m2 The lower border of the tumor is located distal to the peritoneal reflection Pregnant woman or lactating woman Severe mental disease Previous abdominal surgery（except appendectomy and cholecystotomy） 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>patients with colorectal cancer and undergo single incision laparoscopic surgery | Procedure: single incision laparoscopic surgery<br>* Patients undergo single incision laparoscopic surgery<br>|
| Placebo Comparator: Conventional laparoscopic surgery<br>patients with colorectal cancer and undergo conventional laparoscopic surgery | Procedure: conventional laparoscopic surgery<br>* Patients undergo conventional laparoscopic surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early morbidity rate | morbidity rate 30 days after surgery | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | Operative time（minutes） | intraoperative | 
| Intraoperative blood loss | Estimated blood loss（milliliters，ml） | intraoperative | 
| Incision length | Incision length（centimeters，cm） | intraoperative | 
| Lymph node detection | Lymph nodes harvested（numbers） | 14 days after surgery | 
| Incisal margin | Length of proximal and distal margin （centimeters，cm） | 14 days after surgery | 
| Tumor size | The diameter of tumors（centimeters，cm） | 14 days after surgery | 
| Length of stay | Duration of hospital stay（days after surgery） | 1-14 days after surgery | 
| Postoperative recovery course | Time to first ambulation, flatus, liquid diet and soft diet （hours after surgery） | 1-14 days after surgery | 
| Pain score | Postoperative pain is recorded using the visual analog scale (VAS) pain score （0-10 points）tool on postoperative day 1, 2, 3 and the day of discharge | 1-3 days after surgery | 
| 3-year disease free survival rate | 3-year disease free survival rate | 36 months after surgery | 
| 5-year overall survival rate | 5-year overall survival rate | 60 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SILS, colorectal cancer