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

Nanfang Hospital, Southern Medical University

Status and phase: Unknown; Phase 2

Conditions: Colorectal Cancer

Treatments: Combination Product: Single incision plus one port laparoscopic surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04268290

NFEC-2019-156

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

SILS plus one assistant ERAS

Experimental group

Description:

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.

Treatment:

Combination Product: Single incision plus one port laparoscopic surgery