Overall Survival, Postoperative Complications
Conditions
Keywords
Left colic artery, Laparoscopic Surgery, Anterior resection of rectum, Rectum cancer
Brief summary
Colorectal cancer is one of the most common tumors in Asia. According to the recent research, surgical procedure could provide more treatment benefit in rectal cancer. Therefore, it was consider that important to standardized and improved the surgical procedure for rectal cancer. With the development of anatomical technique, minimally surgery with laparoscopy had become the trend for surgical treatment. There were several studies has been done to evaluate the safety and feasibility of laparoscopic surgery. In order to achieve better surgical outcome and reduce operative complications, the investigators design stratified randomization, double blinded, muti - center clinical trail to investigate the value of left colic artery in laparoscopic radical rectectomy.
Interventions
PROCEDURELCA-nP
The group underwent lapaoroscopic radical rectectomy without preserving left colic artery.
PROCEDURELCA-P
The group underwent lapaoroscopic radical rectectomy with preserving left colic artery.
Sponsors
Shanghai Minimally Invasive Surgery Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Aged more then 18 years old; * Diagnosed as rectal cancer with colonoscopic biopsy; * Without metastasis; * No Invasion of surrounding tissues; * Limited operation; * Underwent laparoscopic radical proctectomy(L-Dixon); * BMI 18\ 30kg/m2; * Without multiple primary tumors; * Sign on the Medical informed Consent.
Exclusion criteria
* Simultaneous or simultaneous multiple primary colorectal cancer; * Preoperative imaging examination results show: (1) Tumor involves the surrounding organs and combined organ resection need to be done; (2)distant metastasis; (3)unable to perform R0 resection; * History of any other malignant tumor in recent 5 years; * Patients need emergency operation; * Not suitable for laparoscopic surgery; * Women during Pregnancy or breast feeding period; * Informed consent refusal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| The rate of postoperative coml[ications and mortality | 30 days |
| 3 years overall survival | 3 years |
| The rate of local and distant recurrence | 3 years |
| The rate of LN.253 metastasis | 2 weeks |
Countries
China
Contacts
Primary ContactMinhua Zheng, PhD
Backup ContactHiju Hong, PhD Student
Outcome results
None listed