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

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

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Combination product: Single incision plus one port laparoscopic surgery

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: SILS plus one assistant ERAS; 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; 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.; Other Names: The program of enhanced recovery After Surgery

What is the study measuring?

Primary Outcome Measures

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

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

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University
• Investigators: Principal Investigator: Wang Yannan, M.D, Nanfang Hospital of Southern Medical University

Publications and helpful links

General Publications

• Zhang X, Li G, Li X, Liang Z, Lan X, Mou T, Xu Z, Fu J, Wu M, Li G, Wang Y. Effect of single-incision plus one port laparoscopic surgery assisted with enhanced recovery after surgery on colorectal cancer: study protocol for a single-arm trial. Transl Cancer Res. 2021 Dec;10(12):5443-5453. doi: 10.21037/tcr-21-1361.

Study record dates

Study Major Dates

• Study Start (Anticipated): February 15, 2020
• Primary Completion (Anticipated): February 15, 2022
• Study Completion (Anticipated): February 15, 2022

Study Registration Dates

• First Submitted: December 25, 2019
• First Submitted That Met QC Criteria: February 12, 2020
• First Posted (Actual): February 13, 2020

Study Record Updates

• Last Update Posted (Actual): February 13, 2020
• Last Update Submitted That Met QC Criteria: February 12, 2020
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Laparoscopic surgery; Colorectal Cancer; ERAS; Single Incision plus one
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: NFEC-2019-156

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No