A randomized controlled clinical trial to compare the short and long outcomes of low anterior resection for middle-low rectal cancer with or without pelvic peritonization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,000
Closure of the pelvic peritoneum after anastomosis for middle-low rectal caner.
Nonclosure of the pelvic peritoneum after anastomosis for middle-low rectal caner.
General Surgery Center of PLA
Chongqing, China
RECRUITINGGrade III-IV complications
The rate of grade III-IV complication according to Clavien-Dindo classification after low anterior resection
Time frame: 30 days
Rate of reoperation
The rate of reoperation after leakage
Time frame: 30 days
Detection of inflammation markers
C-reactive protein(1, 3, 5, 7 days after operation, and 1 day before discharge, all blood drawn is venous blood)
Time frame: 7 days
The rate of anastomotic leakage
Clinical diagnostic criteria for anastomotic leakage: 1. Abdominal and systemic infection symptoms: abdominal pain, bloating, fever, elevated white blood cells, PCT, CRP and other inflammation indicators; 2. Gas, pus, feces passing through the pelvic drainage tube, abdominal incision, etc.
Time frame: 30 days
Hospital time
Comparison of hospital stay between the two groups
Time frame: 30 days
Overall complication rate
Overall complication rate include I-IV grade
Time frame: 30days
Estimated blood loss
Blood loss will be measured according to the suction and the weight of wet gauze, and then minus the irrigation
Time frame: 1 day
Operation time
The time from start to end of surgery
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Time frame: 1 day
Postoperative bleeding
Postoperative intra-abdominal bleeding
Time frame: 7 days
Intestinal obstruction
Incidence of intestinal obstruction caused by various reasons after surgery
Time frame: 30 days
Readmission rate
Rate of hospital readmissions due to complications after discharge
Time frame: 30 days
LARS
Low Anterior resection syndrome caused by rectal surgery
Time frame: 12 months
Acute inflammatory Response
Procalcitonin(1, 3, 5, 7 days after operation, and 1 day before discharge, all blood drawn is venous blood)
Time frame: 7 days
Acute inflammatory Response
Check Neutrophils(1, 3, 5, 7 days after operation, and 1 day before discharge, all blood drawn is venous blood)
Time frame: 7 days
Detection of other inflammation markers
interleukin-6(1, 3, 5, 7 days after operation, and 1 day before discharge, all blood drawn is venous blood)
Time frame: 7 days
Treatment cost
Comparison of cost between the two groups
Time frame: 30 days