Single-incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer

Study Overview
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Brief Summary
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This study is designed to evaluate the short-term and long-term results after single incision laparoscopic surgery for colorectal cancer（SILSC） compared with conventional laparoscopic surgery for colorectal cancer（CLSC）.

Detailed Description
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In order to improve cosmetic effect and reduce postoperative pain, single-incision laparoscopic surgery (SILS) is attracting increasing attention. SILS is considered to be the next major advance in the progress of minimally invasive surgical approaches to colorectal disease that is more feasible in generalized use. In most previous studies, SILS for colorectal cancer was feasible and short-term safe compared to conventional laparoscopic surgery (CLS) . However, there is still controversy over its potential better cosmetic effect and less postoperative pain. Moreover, the long-term oncologic outcomes are still inconclusive as only a few studies showed long-term survival data. Up to now, most studies were limited to their retrospective nature and small samples. So more studies, especially large-scale, randomized controlled trials are needed to establish the best indications for SILS for colorectal cancer.

Official Title
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Multi-center Prospective Randomized Controlled Study of the Single-incision Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Colorectal Cancer

Conditions
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Colorectal Cancer, Colonic Neoplasms, Rectal Neoplasms, Colon Disease, Colon Cancer, Rectal Cancer, Rectal Diseases

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: Inclusion Criteria: 18 years < age ≤85 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 8th 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) >35 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: 85 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: Conventional Laparoscopic Surgery<br>Patients with colorectal cancer undergo conventional laparoscopic surgery（multi-ports）. | Procedure: Conventional Laparoscopic Surgery<br>* Patients undergo conventional laparoscopic surgery. In this group，the surgery is performed through 3-5 ports according to the surgeons habits and specific conditions.<br>* Other names: CLSC;|
| Experimental: Single-incision Laparoscopic Surgery<br>Patients with colorectal cancer undergo single-incision laparoscopic surgery. | Procedure: Single-incision Laparoscopic Surgery<br>* Patients undergo single-incision laparoscopic surgery. In this group，the surgery is performed through a transumbilical port. The surgeon will adjust surgical position to expose the operative field with the help of gravity. Besides，hand over hand cross and parallel techniques are needed to achieve the SILS. All the other operative procedures are the same as conventional laparoscopic surgery.<br>* Other names: SILSC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Postoperative complications rate 30 days after surgery | 30 days after surgery | 

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