PR in Endoscopic LAR for Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
The anastomotic leakage remains the major early complication after laparoscopic anterior resection(LAR) for medium & low rectal cancer. Pelvic floor reconstruction (PR) is a key step in various standard resections for open radical rectal cancer surgery, which was considered to be helpful for decreasing the rate of leakage. However, PR in endoscopic LAR surgery is not routine practice and remains controversial. The purpose of this study is to evaluate the efficacy of PR during LAR for mid/low rectal carcinoma, especially in preventing anastomotic leakage.

Detailed Description
-----------------
Eligible patients with rectal cancer will be randomly assigned to group with pelvic floor reconstruction(PR) versus group without pelvic floor reconstruction(NPR). We want to investigate the rate of anastomotic leakage and re-operation between the two groups, some other relevant outcomes will be concerned all the same.

Official Title
-----------------
Pelvic Floor Reconstruction (PR) in Endoscopic Low Anterior Resection for Rectal Cancer

Conditions
-----------------
Rectal Carcinoma

Intervention / Treatment
-----------------
* Procedure: Pelvic floor Reconstruction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with histologically proven rectal adenocarcinoma tumor located in the middle and lower rectum and anastomosis under the peritoneal reflection Tumor assessed as a depth of invasion that was confined to pT1-pT3, bN0-1M0 by ultrasound colonoscopy and/or pelvic MRI Negative circumferential resection margin confirmed by MRI Performance status (ECOG) 0 1 Written informed consent for participation in the trial Exclusion Criteria: History of accepting lower abdominal surgery. More than one colorectal tumor Patients with unresectable distant metastasis or multiple metastases Received neoadjuvant radiotherapy before surgery Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery Patients and/or family members cannot understand and accept this study Non-rectal adenocarcinoma was confirmed by postoperative pathological examination

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PR<br> | Procedure: Pelvic floor Reconstruction<br>* Pelvic floor Reconstruction after laparoscopic anterior resection and double-stapling technique anastomosis were finished.<br>|
| Active Comparator: Non-PR<br> | Procedure: Pelvic floor Reconstruction<br>* Pelvic floor Reconstruction after laparoscopic anterior resection and double-stapling technique anastomosis were finished.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of anastomotic leakage after laparoscopic anterior resection for rectal cancer |  | 30 days after surgery | 
| Re-operation rate after anastomotic leakage |  | 30 days after surgery | 
| The rate of general complications |  | 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time |  | Operation day | 
| Postoperative hospital stay |  | 1 year after surgery | 
| Incidence of defecation dysfunction |  | From the date of operation until the date of complication,assessed up to 3 years | 
| 3-year local recurrence rate |  | From date of operation until the date of local-recurrence (up to 3 years) | 
| 5-year disease-free survival |  | From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years | 
| Postoperative quality of life as assessed by EORTC QLQ-C30 questionnaire |  | 1 year after operation | 
| Blood loss |  | Operation day | 
| White blood cells(WBC) ,C-reactive protein (CRP) and procalcitonin (PCT) count in the blood sample |  | 1 days after surgery | 
| White blood cells(WBC) ,C-reactive protein (CRP) and procalcitonin (PCT) count in the blood sample |  | 3 days after surgery | 
| White blood cells(WBC) ,C-reactive protein (CRP) and procalcitonin (PCT) count in the blood sample |  | 5 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
minimally invasive surgical