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

Rectum Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03699761
• Other study ID #: POLAR
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Rectal Neoplasms
• Rectum Cancer

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