The Role of Pelvic Peritonization in Laparoscopic or Robotic Low Anterior Resection
- Conditions
- Rectum Cancer
- Interventions
- Procedure: Closure of the pelvic peritoneumProcedure: Nonclosure of the pelvic peritoneum
- Registration Number
- NCT03699761
- Lead Sponsor
- Southwest Hospital, China
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- Matching the diagnostic criteria of rectal adenocarcinoma
- Laparoscopic or robotic radical surgery for rectal cancer
- Preoperative TNM staging T1-3N0-2M0
- No history of malignant tumors by preoperative examination
- Middle and low rectal cancer
- Tumor size of 4 cm or less
- ASA 1-3 scores
- Written informed consent by the patient
- The patient is willing to randomize to any group
- Previous abdominal surgery
- Past malignant tumor history
- Preoperative examination suggests distant metastasis
- Be participating or have participated in other clinical studies related to rectal cancer surgery within 6 months
- Emergency operation
Elimination criteria
- The tumor is confirmed to be T4b during the operation or other tumors are found to be combined with other tumors during the operation
- The anastomosis is located above the peritoneum reflex
- Intraoperative conversion to laparotomy
- Change the surgical method to perform Miles or Hartmann surgery
- Postoperative pathologically confirmed non-adenocarcinoma
- The patient asked to withdraw
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pelvic Peritonization Nonclosure of the pelvic peritoneum - Pelvic Peritonization Closure of the pelvic peritoneum -
- Primary Outcome Measures
Name Time Method Grade III-IV complications 30 days The rate of grade III-IV complication according to Clavien-Dindo classification after low anterior resection
- Secondary Outcome Measures
Name Time Method Rate of reoperation 30 days The rate of reoperation after leakage
Hospital time 30 days Comparison of hospital stay between the two groups
Operation time 1 day The time from start to end of surgery
Treatment cost 30 days Comparison of cost between the two groups
LARS 12 months Low Anterior resection syndrome caused by rectal surgery
Detection of other inflammation markers 7 days interleukin-6(1, 3, 5, 7 days after operation, and 1 day before discharge, all blood drawn is venous blood)
Estimated blood loss 1 day Blood loss will be measured according to the suction and the weight of wet gauze, and then minus the irrigation
Acute inflammatory Response 7 days Check Neutrophils(1, 3, 5, 7 days after operation, and 1 day before discharge, all blood drawn is venous blood)
Detection of inflammation markers 7 days C-reactive protein(1, 3, 5, 7 days after operation, and 1 day before discharge, all blood drawn is venous blood)
Overall complication rate 30days Overall complication rate include I-IV grade
Readmission rate 30 days Rate of hospital readmissions due to complications after discharge
The rate of anastomotic leakage 30 days 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.
Postoperative bleeding 7 days Postoperative intra-abdominal bleeding
Intestinal obstruction 30 days Incidence of intestinal obstruction caused by various reasons after surgery
Trial Locations
- Locations (1)
General Surgery Center of PLA
🇨🇳Chongqing, China