Rectum Cancer
Conditions
Keywords
Anastomotic leakage, Complication, Reoperation, Pelvic Peritonization
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.
Interventions
PROCEDUREClosure of the pelvic peritoneum
Closure of the pelvic peritoneum after anastomosis for middle-low rectal caner.
PROCEDURENonclosure of the pelvic peritoneum
Nonclosure of the pelvic peritoneum after anastomosis for middle-low rectal caner.
Sponsors
Southwest Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grade III-IV complications | 30 days | The rate of grade III-IV complication according to Clavien-Dindo classification after low anterior resection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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. |
| Hospital time | 30 days | Comparison of hospital stay between the two groups |
| Overall complication rate | 30days | Overall complication rate include I-IV grade |
| 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 |
| Operation time | 1 day | The time from start to end of surgery |
| Rate of reoperation | 30 days | The rate of reoperation after leakage |
| Intestinal obstruction | 30 days | Incidence of intestinal obstruction caused by various reasons after surgery |
| Readmission rate | 30 days | Rate of hospital readmissions due to complications after discharge |
| LARS | 12 months | Low Anterior resection syndrome caused by rectal surgery |
| Acute inflammatory Response | 7 days | Procalcitonin(1, 3, 5, 7 days after operation, and 1 day before discharge, all blood drawn is venous blood) |
| 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) |
| Treatment cost | 30 days | Comparison of cost between the two groups |
| Postoperative bleeding | 7 days | Postoperative intra-abdominal bleeding |
Countries
China
Contacts
Primary ContactTang Bo, MD
Backup ContactLi Chuan
Outcome results
None listed