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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04268290
• Other study ID #: NFEC-2019-156
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 15, 2020
• Est. completion date: February 15, 2022

Study information

• Verified date: November 2019
• Source: Nanfang Hospital of Southern Medical University
• Contact: Wang Yanan, M.D
• Phone: +86-131-8909-6629
• Email: wyn8116[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: February 15, 2022
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Surgical Wound

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rehabilitative rate	The percentage of patients who met discharge criteria in the fourth day after surgery	4 days
Primary	Postoperative hospital stays	Days from surgery to discharge	1 month
Secondary	Medical cost	The patient's expenses from surgery to discharge are recorded in RMB "yuan"	1 month
Secondary	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
Secondary	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
Secondary	Postoperative inflammatory immune response	It includes the number of white blood cells and lymphocytes,CRP, IL-6	3 days
Secondary	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
Secondary	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
Secondary	hospital readmissions	It can be defined as the number of patients readmitted within 30 days because of postoperative complications.	30days
Secondary	Morbidity and mortality rates	Morbidity and mortality rates are defined as postoperative complications graded according to Clavien-Dindo within 30 days.	30 days