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

• Sponsor: Southwest Hospital, China (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03699761
• Collaborator: (none)
• Enrollment: 1,000
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 41.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rectum Cancer	Procedure: Closure of the pelvic peritoneum; Procedure: Nonclosure of the pelvic peritoneum	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1000 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Pelvic Peritonization in Robotic or Laparoscopic Low Anterior Resection for Rectal Cancer
• Anticipated Study Start Date: Sep 1, 2020
• Anticipated Primary Completion Date: Aug 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Grade III-IV complications [30 days]

   The rate of grade III-IV complication according to Clavien-Dindo classification after low anterior resection

Secondary Outcome Measures

1. Rate of reoperation [30 days]

   The rate of reoperation after leakage

2. 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)

3. 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.

4. Hospital time [30 days]

   Comparison of hospital stay between the two groups

5. Overall complication rate [30days]

   Overall complication rate include I-IV grade

6. 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

7. Operation time [1 day]

   The time from start to end of surgery

8. Postoperative bleeding [7 days]

   Postoperative intra-abdominal bleeding

9. Intestinal obstruction [30 days]

   Incidence of intestinal obstruction caused by various reasons after surgery

10. Readmission rate [30 days]

    Rate of hospital readmissions due to complications after discharge

11. LARS [12 months]

    Low Anterior resection syndrome caused by rectal surgery

12. Acute inflammatory Response [7 days]

    Procalcitonin(1, 3, 5, 7 days after operation, and 1 day before discharge, all blood drawn is venous blood)

13. Acute inflammatory Response [7 days]

    Check Neutrophils(1, 3, 5, 7 days after operation, and 1 day before discharge, all blood drawn is venous blood)

14. 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)

15. Treatment cost [30 days]

    Comparison of cost between the two groups

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	General Surgery Center of PLA	Chongqing		China	400038

Sponsors and Collaborators

• Southwest Hospital, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tang Bo, Principal Investigator, Southwest Hospital, China
• ClinicalTrials.gov Identifier: NCT03699761
• Other Study ID Numbers: POLAR
• First Posted: Oct 9, 2018
• Last Update Posted: Aug 20, 2020
• Last Verified: Aug 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Tang Bo, Principal Investigator, Southwest Hospital, China: Anastomotic leakage; Complication; Reoperation; Pelvic Peritonization
• Additional relevant MeSH terms: Rectal Neoplasms

Study Results

No Results Posted as of Aug 20, 2020