Back to resultsThe Role of Pelvic Peritonization in Laparoscopic or Robotic Low Anterior Resection
Primary Purpose
Rectum Cancer
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Closure of the pelvic peritoneum
Nonclosure of the pelvic peritoneum
Sponsored by
About this trial
This is an interventional treatment trial for Rectum Cancer focused on measuring Anastomotic leakage, Complication, Reoperation, Pelvic Peritonization
Eligibility Criteria
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
Sites / Locations
- General Surgery Center of PLARecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pelvic Peritonization
Without Pelvic Peritonization
Arm Description
Outcomes
Primary Outcome Measures
Grade III-IV complications
The rate of grade III-IV complication according to Clavien-Dindo classification after low anterior resection
Secondary Outcome Measures
Rate of reoperation
The rate of reoperation after leakage
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)
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.
Hospital time
Comparison of hospital stay between the two groups
Overall complication rate
Overall complication rate include I-IV grade
Estimated blood loss
Blood loss will be measured according to the suction and the weight of wet gauze, and then minus the irrigation
Operation time
The time from start to end of surgery
Postoperative bleeding
Postoperative intra-abdominal bleeding
Intestinal obstruction
Incidence of intestinal obstruction caused by various reasons after surgery
Readmission rate
Rate of hospital readmissions due to complications after discharge
LARS
Low Anterior resection syndrome caused by rectal surgery
Acute inflammatory Response
Procalcitonin(1, 3, 5, 7 days after operation, and 1 day before discharge, all blood drawn is venous blood)
Acute inflammatory Response
Check Neutrophils(1, 3, 5, 7 days after operation, and 1 day before discharge, all blood drawn is venous blood)
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)
Treatment cost
Comparison of cost between the two groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03699761
Brief Title
The Role of Pelvic Peritonization in Laparoscopic or Robotic Low Anterior Resection
Official Title
Evaluation of Pelvic Peritonization in Robotic or Laparoscopic Low Anterior Resection for Rectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southwest Hospital, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectum Cancer
Keywords
Anastomotic leakage, Complication, Reoperation, Pelvic Peritonization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pelvic Peritonization
Arm Type
Experimental
Arm Title
Without Pelvic Peritonization
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Closure of the pelvic peritoneum
Intervention Description
Closure of the pelvic peritoneum after anastomosis for middle-low rectal caner.
Intervention Type
Procedure
Intervention Name(s)
Nonclosure of the pelvic peritoneum
Intervention Description
Nonclosure of the pelvic peritoneum after anastomosis for middle-low rectal caner.
Primary Outcome Measure Information:
Title
Grade III-IV complications
Description
The rate of grade III-IV complication according to Clavien-Dindo classification after low anterior resection
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Rate of reoperation
Description
The rate of reoperation after leakage
Time Frame
30 days
Title
Detection of inflammation markers
Description
C-reactive protein(1, 3, 5, 7 days after operation, and 1 day before discharge, all blood drawn is venous blood)
Time Frame
7 days
Title
The rate of anastomotic leakage
Description
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.
Time Frame
30 days
Title
Hospital time
Description
Comparison of hospital stay between the two groups
Time Frame
30 days
Title
Overall complication rate
Description
Overall complication rate include I-IV grade
Time Frame
30days
Title
Estimated blood loss
Description
Blood loss will be measured according to the suction and the weight of wet gauze, and then minus the irrigation
Time Frame
1 day
Title
Operation time
Description
The time from start to end of surgery
Time Frame
1 day
Title
Postoperative bleeding
Description
Postoperative intra-abdominal bleeding
Time Frame
7 days
Title
Intestinal obstruction
Description
Incidence of intestinal obstruction caused by various reasons after surgery
Time Frame
30 days
Title
Readmission rate
Description
Rate of hospital readmissions due to complications after discharge
Time Frame
30 days
Title
LARS
Description
Low Anterior resection syndrome caused by rectal surgery
Time Frame
12 months
Title
Acute inflammatory Response
Description
Procalcitonin(1, 3, 5, 7 days after operation, and 1 day before discharge, all blood drawn is venous blood)
Time Frame
7 days
Title
Acute inflammatory Response
Description
Check Neutrophils(1, 3, 5, 7 days after operation, and 1 day before discharge, all blood drawn is venous blood)
Time Frame
7 days
Title
Detection of other inflammation markers
Description
interleukin-6(1, 3, 5, 7 days after operation, and 1 day before discharge, all blood drawn is venous blood)
Time Frame
7 days
Title
Treatment cost
Description
Comparison of cost between the two groups
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tang Bo, MD
Phone
+8613883902288
Email
tangtbo@sina.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Li Chuan
Phone
+86-18323479228
Email
lee_tran@126.com
Facility Information:
Facility Name
General Surgery Center of PLA
City
Chongqing
ZIP/Postal Code
400038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tang Bo, M.D/Ph.D
Phone
+862368754167
Email
tangtbo@sina.com
12. IPD Sharing Statement
Learn more about this trial
The Role of Pelvic Peritonization in Laparoscopic or Robotic Low Anterior Resection
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