Single Incision Laparoscopic Colorectal Surgery
- Conditions
- Laparoscopic Colorectal Surgery
- Interventions
- Procedure: single incision laparoscopic surgeryProcedure: conventional laparoscopic surgery
- Registration Number
- NCT03151733
- Lead Sponsor
- Ruijin Hospital
- Brief Summary
Single incision laparoscopic surgery (SILS) is the further development of the concept of minimally invasive surgery for colorectal cancer,which rapidly developed in the field of colorectal surgery. Through the development of single hole laparoscopic colorectal cancer radical surgery and clinical study and follow up accordingly, evaluating the feasibility, surgical effectiveness and economy help to promote the popularization and application of single hole laparoscopic techniques in the field.
- Detailed Description
The patients with colorectal cancer will randomly divided into single incision laparoscopic surgery group and conditional laparoscopic surgery group. The operation time, blood loss, the incidence of lymph node , the number of postoperative complications, the gastrointestinal function recovery time, postoperative hospital stay，the number of local recurrence and distant metastasis, survival rate and the total cost of hospitalization will be evaluated to confirm the feasibility of single incision laparoscopic surgery is effective and economical. It is worthy of clinical application.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- 18 years < age < 80 years
- Tumor located in colon and high rectum ( the lower border of the tumor is above the peritoneal reflection)
- Pathological colorectal carcinoma
- Clinically diagnosed cT1-4aN0-2 M0 lesions according to the 7th Edition of AJCC Cancer Staging Manual
- Tumor size of 5 cm or less
- ECOG score is 0-1
- ASA score is Ⅰ-Ⅲ
- Informed consent
- Body mass index (BMI) >30 kg/m2
- The lower border of the tumor is located distal to the peritoneal reflection
- Pregnant woman or lactating woman
- Severe mental disease
- Previous abdominal surgery（except appendectomy and cholecystotomy）
- Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer
- Requirement of simultaneous surgery for other disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description single incision laparoscopic surgery single incision laparoscopic surgery patients with colorectal cancer and undergo single incision laparoscopic surgery Conventional laparoscopic surgery conventional laparoscopic surgery patients with colorectal cancer and undergo conventional laparoscopic surgery
- Primary Outcome Measures
Name Time Method Early morbidity rate 30 days morbidity rate 30 days after surgery
- Secondary Outcome Measures
Name Time Method Lymph node detection 14 days after surgery Lymph nodes harvested（numbers）
Tumor size 14 days after surgery The diameter of tumors（centimeters，cm）
3-year disease free survival rate 36 months after surgery 3-year disease free survival rate
Operative time intraoperative Operative time（minutes）
5-year overall survival rate 60 months after surgery 5-year overall survival rate
Intraoperative blood loss intraoperative Estimated blood loss（milliliters，ml）
Incision length intraoperative Incision length（centimeters，cm）
Incisal margin 14 days after surgery Length of proximal and distal margin （centimeters，cm）
Length of stay 1-14 days after surgery Duration of hospital stay（days after surgery）
Postoperative recovery course 1-14 days after surgery Time to first ambulation, flatus, liquid diet and soft diet （hours after surgery）
Pain score 1-3 days after surgery Postoperative pain is recorded using the visual analog scale (VAS) pain score （0-10 points）tool on postoperative day 1, 2, 3 and the day of discharge
Trial Locations
- Locations (1)
ruijin hospital North
🇨🇳Shanghai, Shanghai, China