Oncologic Outcomes of 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 investigate long-term oncologic outcomes of single-incision laparoscopic surgery (SILS) compared to conventional laparoscopic surgery (CLS) for colorectal cancer.

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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Oncologic Outcomes of Single-incision Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Colorectal Cancer: A Multi-center, Prospective, Open Label, Non-inferiority, Randomized Controlled Trial

Conditions
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Colorectal Cancer, Colon Cancer, Rectal 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 ≤85 years Tumor located in colon and high rectum ( the lower border of the tumor is above the peritoneal reflection) Pathological or highly suspected 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 Familial adenomatous polyposis (FAP) Inflammatory bowel disease (IBD) Multiple malignant colorectal tumors Pregnant woman or lactating woman Severe mental disease Previous gastrointestinal surgery (except appendectomy ） Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer Requirement of simultaneous surgery for other disease Simultaneous or metachronous multiple cancers with disease-free survival ≤ 5 years

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 |
| --- | --- |
| Experimental: Single-incision Laparoscopic Surgery<br>Patients with colorectal cancer undergo single-incision laparoscopic surgery. | Procedure: Single-incision Laparoscopic Surgery<br>* In this group，the surgery is performed through a single incision. 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: SILS;|
| Active Comparator: Conventional Laparoscopic Surgery<br>Patients with colorectal cancer undergo conventional laparoscopic surgery（3 5 ports）. | Procedure: Conventional Laparoscopic Surgery<br>* In this group，the surgery is performed through 3-5 ports according to the surgeons habits and specific conditions.<br>* Other names: CLS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year disease free survival rate | 3-year disease free survival rate | 36 months 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 | 
| Total incision length | The sum of all incision lengths（centimeters，cm） | intraoperative | 
| Conversion rate | The proportion of converted to laparotomy and added trocars（%） | intraoperative | 
| Length of stay | The postoperative day when patients complied with the predefined discharge criteria（days after surgery） | 1-14 days after surgery | 
| Postoperative recovery course | Time to first ambulation, flatus, liquid diet and semi-liquid diet （hours after surgery） | 1-14 days after surgery | 
| Early morbidity rate | morbidity rate 30 days after surgery | 30 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 | 1-3 days after surgery | 
| Tumor size | The diameter of tumors（centimeters，cm） | 14 days after surgery | 
| Incisal margin | Length of proximal and distal margin （centimeters，cm） | 14 days after surgery | 
| Lymph node detection | Lymph nodes harvested（numbers） | 14 days after surgery | 
| Cosmetic effect | Assessed using a Beauty Questionnaire evaluating patient's satisfaction according to a 5-scale score, ranging from ''Not satisfied at all'' to ''Very satisfied'' | 1 month, 6 months and 1 year after surgery | 
| The quality of life-Core | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) | 1 month, 6 months and 1 year after surgery | 
| The quality of life-Colorectal | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal 29 (EORTC QLQ-CR29) | 1 month, 6 months and 1 year 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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single-incision laparoscopic surgery, conventional laparoscopic surgery, colorectal cancer