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

Phase 2

• Conditions: Colorectal Cancer
• Interventions: Combination Product: Single incision plus one port laparoscopic surgery

• Registration Number: NCT04268290
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-11
• Study First Submitted: 2019-12-25
• Study First Submitted QC: 2020-02-12
• Last Update Submitted: 2020-02-12
• Study First Posted: 2020-02-13
• Last Update Posted: 2020-02-13
• Study Start: 2020-02-15
• Primary Completion: 2022-02-15
• Study Completion: 2022-02-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SILS plus one assistant ERAS	Single incision plus one port laparoscopic surgery	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.

Primary Outcome Measures

Name	Time	Method
Rehabilitative rate	4 days	The percentage of patients who met discharge criteria in the fourth day after surgery
Postoperative hospital stays	1 month	Days from surgery to discharge

Secondary Outcome Measures

Name	Time	Method
hospital readmissions	30days	It can be defined as the number of patients readmitted within 30 days because of postoperative complications.
6 min postoperative walking test(6MWT)	Once a day from the frist to the fourth day after surgery	Study site, subject preparation, trial procedures, and medical monitoring refer to the 6MWT guidelines issued by the American thoracic society in 2002.
Medical cost	1 month	The patient's expenses from surgery to discharge are recorded in RMB "yuan"
Postoperative recovery index	1 month	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
Postoperative pain score	Once a day from 6 hours to the fourth day after surgery	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.
Postoperative inflammatory immune response	3 days	It includes the number of white blood cells and lymphocytes,CRP, IL-6
compliance with ERAS measures	perioperative	It is defined as if the patients complete every ERAS measure or not. We can defined it "yes " or "not".
Morbidity and mortality rates	30 days	Morbidity and mortality rates are defined as postoperative complications graded according to Clavien-Dindo within 30 days.