Colorectal Cancer
Conditions
Keywords
Colorectal Cancer, ERAS, Single Incision plus one, Laparoscopic surgery
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.
Interventions
COMBINATION_PRODUCTSingle 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.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rehabilitative rate | 4 days | The percentage of patients who met discharge criteria in the fourth day after surgery |
| Postoperative hospital stays | 1 month | Days from surgery to discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative recovery index | 1 month | 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 |
| Postoperative inflammatory immune response | 3 days | It includes the number of white blood cells and lymphocytes,CRP, IL-6 |
| compliance with ERAS measures | perioperative | It is defined as if the patients complete every ERAS measure or not. We can defined it yes or not. |
| Medical cost | 1 month | The patient's expenses from surgery to discharge are recorded in RMB yuan |
| hospital readmissions | 30days | It can be defined as the number of patients readmitted within 30 days because of postoperative complications. |
| Morbidity and mortality rates | 30 days | Morbidity and mortality rates are defined as postoperative complications graded according to Clavien-Dindo within 30 days. |
| 6 min postoperative walking test(6MWT) | Once a day from the frist to the fourth day after surgery | Study site, subject preparation, trial procedures, and medical monitoring refer to the 6MWT guidelines issued by the American thoracic society in 2002. |
| Postoperative pain score | Once a day from 6 hours to the fourth day after surgery | 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. |
Contacts
Primary ContactWang Yanan, M.D
Outcome results
None listed