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
1 other identifier
interventional
120
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 colorectal-cancer
Started Feb 2020
Shorter than P25 for phase_2 colorectal-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 25, 2019
CompletedFirst Posted
Study publicly available on registry
February 13, 2020
CompletedStudy Start
First participant enrolled
February 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2022
CompletedFebruary 13, 2020
November 1, 2019
2 years
December 25, 2019
February 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Rehabilitative rate
The percentage of patients who met discharge criteria in the fourth day after surgery
4 days
Postoperative hospital stays
Days from surgery to discharge
1 month
Secondary Outcomes (8)
Medical cost
1 month
Postoperative pain score
Once a day from 6 hours to the fourth day after surgery
Postoperative recovery index
1 month
Postoperative inflammatory immune response
3 days
compliance with ERAS measures
perioperative
- +3 more secondary outcomes
Study Arms (1)
SILS plus one assistant ERAS
EXPERIMENTALPreoperative: 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 35116390DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wang Yannan, M.D
Nanfang Hospital, Southern Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 25, 2019
First Posted
February 13, 2020
Study Start
February 15, 2020
Primary Completion
February 15, 2022
Study Completion
February 15, 2022
Last Updated
February 13, 2020
Record last verified: 2019-11