Clinical trial NCT04268290: Single Incision Plus One Port Laparoscopic Surgery Assistant Enhanced Recovery After Surgery on Colorectal Cancer
Official title: Effect of Single Incision Plus One Port Laparoscopic Surgery Assistant Enhanced Recovery After Surgery on Colorectal Cancer : A Single Arm Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: Colorectal Cancer
ERAS
Single Incision plus one
Laparoscopic surgery
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rehabilitative rate
timeFrame: 4 days
measure: Postoperative hospital stays
timeFrame: 1 month
Secondary outcomes:
measure: Medical cost
timeFrame: 1 month
measure: Postoperative pain score
timeFrame: Once a day from 6 hours to the fourth day after surgery
measure: Postoperative recovery index
timeFrame: 1 month
measure: Postoperative inflammatory immune response
timeFrame: 3 days
measure: compliance with ERAS measures
timeFrame: perioperative
measure: 6 min postoperative walking test(6MWT)
timeFrame: Once a day from the frist to the fourth day after surgery
measure: hospital readmissions
timeFrame: 30days
measure: Morbidity and mortality rates
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Wang Yannan, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.