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

Army Medical University

Status

Enrolling

Conditions

Rectum Cancer

Treatments

Procedure: Nonclosure of the pelvic peritoneum

Procedure: Closure of the pelvic peritoneum

Study type

Interventional

Funder types

Other

Identifiers

NCT03699761

POLAR

Details and patient eligibility

About

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.

Enrollment

1,000 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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