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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rectum Cancer
• Intervention / Treatment: Procedure: Closure of the pelvic peritoneum; Procedure: Nonclosure of the pelvic peritoneum

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tang Bo, MD; Phone Number: +8613883902288; Email: tangtbo@sina.cn
• Study Contact Backup: Name: Li Chuan; Phone Number: +86-18323479228; Email: lee_tran@126.com

Study Locations

• China
  • Chongqing, China, 400038
    • Recruiting
    • General Surgery Center of PLA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Southwest Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): August 1, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: October 5, 2018
• First Submitted That Met QC Criteria: October 5, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Anastomotic leakage; Complication; Reoperation; Pelvic Peritonization
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: POLAR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No