The Role of Pelvic Peritonization in Laparoscopic or Robotic Low Anterior Resection

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Pelvic Peritonization in Robotic or Laparoscopic Low Anterior Resection for Rectal Cancer

Conditions
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Rectum Cancer

Intervention / Treatment
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* Procedure: Closure of the pelvic peritoneum
* Procedure: Nonclosure of the pelvic peritoneum


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pelvic Peritonization<br> | Procedure: Closure of the pelvic peritoneum<br>* Closure of the pelvic peritoneum after anastomosis for middle-low rectal caner.<br>Procedure: Nonclosure of the pelvic peritoneum<br>* Nonclosure of the pelvic peritoneum after anastomosis for middle-low rectal caner.<br>|
| No Intervention: Without Pelvic Peritonization<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade III-IV complications | The rate of grade III-IV complication according to Clavien-Dindo classification after low anterior resection | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of reoperation | The rate of reoperation after leakage | 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) | 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. | 30 days | 
| Hospital time | Comparison of hospital stay between the two groups | 30 days | 
| Overall complication rate | Overall complication rate include I-IV grade | 30days | 
| Estimated blood loss | Blood loss will be measured according to the suction and the weight of wet gauze, and then minus the irrigation | 1 day | 
| Operation time | The time from start to end of surgery | 1 day | 
| Postoperative bleeding | Postoperative intra-abdominal bleeding | 7 days | 
| Intestinal obstruction | Incidence of intestinal obstruction caused by various reasons after surgery | 30 days | 
| Readmission rate | Rate of hospital readmissions due to complications after discharge | 30 days | 
| LARS | Low Anterior resection syndrome caused by rectal surgery | 12 months | 
| Acute inflammatory Response | Procalcitonin(1, 3, 5, 7 days after operation, and 1 day before discharge, all blood drawn is venous blood) | 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) | 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) | 7 days | 
| Treatment cost | Comparison of cost between the two groups | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anastomotic leakage, Complication, Reoperation, Pelvic Peritonization