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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03699761
Other study ID # POLAR
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date September 1, 2024

Study information

Verified date May 2023
Source Southwest Hospital, China
Contact Tang Bo, MD
Phone +8613883902288
Email tangtbo@sina.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date September 1, 2024
Est. primary completion date August 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Closure of the pelvic peritoneum
Closure of the pelvic peritoneum after anastomosis for middle-low rectal caner.
Nonclosure of the pelvic peritoneum
Nonclosure of the pelvic peritoneum after anastomosis for middle-low rectal caner.

Locations

Country Name City State
China General Surgery Center of PLA Chongqing

Sponsors (1)

Lead Sponsor Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Grade III-IV complications The rate of grade III-IV complication according to Clavien-Dindo classification after low anterior resection 30 days
Secondary Rate of reoperation The rate of reoperation after leakage 30 days
Secondary 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
Secondary 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
Secondary Hospital time Comparison of hospital stay between the two groups 30 days
Secondary Overall complication rate Overall complication rate include I-IV grade 30days
Secondary 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
Secondary Operation time The time from start to end of surgery 1 day
Secondary Postoperative bleeding Postoperative intra-abdominal bleeding 7 days
Secondary Intestinal obstruction Incidence of intestinal obstruction caused by various reasons after surgery 30 days
Secondary Readmission rate Rate of hospital readmissions due to complications after discharge 30 days
Secondary LARS Low Anterior resection syndrome caused by rectal surgery 12 months
Secondary Acute inflammatory Response Procalcitonin(1, 3, 5, 7 days after operation, and 1 day before discharge, all blood drawn is venous blood) 7 days
Secondary 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
Secondary 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
Secondary Treatment cost Comparison of cost between the two groups 30 days
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