Single Incision Plus One Port Laparoscopic Surgery Assistant Enhanced Recovery After Surgery on Colorectal Cancer

Study Overview
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Brief Summary
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Conventional laparoscopic surgery (CLS) for colorectal cancer has been demonstrated to be safe and feasible and present minimally invasive benefits including faster recovery, reduced postoperative pain and shorter hospital stay, also acquiring comparable oncologic outcomes with open surgery. To achieve further minimally invasive outcomes, SILS plus one port surgery was attempted by some surgeons. Preliminary results showed that SILS+1 could achieve better minimally invasive benefits than CLS while preserving oncologic feasibility. Till now, ERAS has been practiced in colorectal cancer surgery for approximately 20 years. Studies have proven that ERAS is safe and significantly improved the recovery course of patients during perioperative period, meanwhile, the expense could be greatly reduced. Based on ERAS studies protocols and SILS+1 trials, investigators tried to combine SILS+1 with ERAS, hopefully to provide patients with more safe, economic, feasible and rapid surgery and perioperative strategies.

Official Title
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Effect of Single Incision Plus One Port Laparoscopic Surgery Assistant Enhanced Recovery After Surgery on Colorectal Cancer : A Single Arm Trial

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Combination Product: Single incision plus one port laparoscopic surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary tumor diagnosed as adenocarcinoma confirmed pathologically by endoscopic biopsy cT1-4a, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition Located in the cecum, ascending colon, transverse colon, descending colon, sigmoid colon, the upper segment of the rectum. Diameter ≦ 5cm No severe organ dysfunction Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale ASA (American Society of Anesthesiology) score class I or II Written informed consent Exclusion Criteria: Unsuitable for patients undergoing single incision plus one port laparoscopic surgery Patients with Complications caused by colorectal cancer ( bleeding , perforation, obstruction or incomplete obstruction ) Previous abdominal surgery Malignant diseases within the past 5years Requirements of simultaneous surgery for another diseases

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SILS plus one assistant ERAS<br>Preoperative: preadmission information, education, counseling, optimization ( breathing training), shortening fasting time and carbohydrate load Intraoperative: The intravenous fluid therapy is restricted. All patients undergo single incision plus one port laparoscopic surgery(SILS plus one). A suitable warming device (such as forced-air heating blankets) and warmed intravenous fluids are been adopted routinely to keep body temperature Postoperative: multimodal analgesia (surgical site infiltration, a nonsteroidal anti-inflammatory drug, epidural analgesia) early oral intake and move. nasogastric tubes should not be used routinely. Nasogastric tubes inserted during surgery are been removed before reversal of an aesthesia. | Combination Product: Single incision plus one port laparoscopic surgery<br>* SILS plus one port surgery and enhanced recovery after surgery protocol both are methods taking the minimally invasive benefits for the patients including faster recovery, reduced postoperative pain and shorter hospital stay.<br>* Other names: The program of enhanced recovery After Surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rehabilitative rate | The percentage of patients who met discharge criteria in the fourth day after surgery | 4 days | 
| Postoperative hospital stays | Days from surgery to discharge | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical cost | The patient's expenses from surgery to discharge are recorded in RMB yuan | 1 month | 
| Postoperative pain score | Postoperative pain is recorded using the visual analog scale (VAS) pain score tool on postoperative day . On a scale of 1 to 10, the higher the score, the greater the pain. | Once a day from 6 hours to the fourth day after surgery | 
| Postoperative recovery index | The first Time to early mobilization(hour), flatus(hour), liquid diet(hour), soft diet(hour), removal of the Nasogastric tubes(hour) , removal of the peritoneal drainage(hour) are used to assess the postoperative recovery | 1 month | 
| Postoperative inflammatory immune response | It includes the number of white blood cells and lymphocytes,CRP, IL-6 | 3 days | 
| compliance with ERAS measures | It is defined as if the patients complete every ERAS measure or not. We can defined it yes  or not. | perioperative | 
| 6 min postoperative walking test(6MWT) | Study site, subject preparation, trial procedures, and medical monitoring refer to the 6MWT guidelines issued by the American thoracic society in 2002. | Once a day from the frist to the fourth day after surgery | 
| hospital readmissions | It can be defined as the number of patients readmitted within 30 days because of postoperative complications. | 30days | 
| Morbidity and mortality rates | Morbidity and mortality rates are defined as postoperative complications graded according to Clavien-Dindo within 30 days. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Cancer, ERAS, Single Incision plus one, Laparoscopic surgery