Extralevator Versus Standard Abdominoperineal Resection For Rectal Adenocarcinoma

Study Overview
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Brief Summary
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This is a study that compares two types of surgery for rectal cancer. There are two procedures that can be used during this surgery, conventional abdominal resection (APR) and extended (or extralevator) APR. The investigators are doing this research to see whether the extralevator APR increases the likelihood that the edge of the tissue that is removed will be more likely to be free from cancer cells compared with the conventional APR surgery. At this time there is no evidence that one type of procedure is better at this than the other. The objective of this research is to determine whether extralevator APR is more likely to have clean margins (free of cancer) compared to the standard APR surgery.

Official Title
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Multicenter Randomized Controlled Trial, Extralevator Versus Standard Abdominoperineal Resection For Rectal Adenocarcinoma

Conditions
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Rectal Adenocarcinoma

Intervention / Treatment
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* Procedure: extralevator APR
* Procedure: APR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Resectable, histologically proven primary adenocarcinoma of the low rectum with internal and/or external sphincter muscle involvement. Staged as follows prior to neoadjuvant chemoradiation: Stage T3 or T4 at MRI N0-2 at MRI M0 at CT scan Patient must undergo long term neoadjuvant chemoradiation: 20 fractions of radiation over ≥5 weeks: total of 50-60 Gy, and chemotherapeutic agents Exclusion Criteria: Squamous cell carcinoma Adenocarcinoma Stage T1-2, any N T4 with one of the following: with pelvic side wall involvement requiring sacrectomy requiring prostatectomy (partial or total) Distant metastasis (M1) Unresectable primary rectal cancer or Inability to complete R0 resection. Recurrent rectal cancer Previous pelvic malignancy Inability to sign informed consent Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: extralevator APR<br>This is a modified and more extensive procedure that is used to remove the levator muscle en bloc with the anal canal and the mesorectum, creating a more cylindrical specimen, so that the amount of tissue removed around the tumor will be larger, thereby reducing the probability that the CRM will be positive. | Procedure: extralevator APR<br>* Extralevator Abdominoperineal Resection For Rectal Adenocarcinoma. The aim of this modified and more extensive procedure is to remove the levator muscle en bloc with the anal canal and the mesorectum, creating a more cylindrical specimen, so that the amount of tissue removed around the tumor will be larger, thereby reducing the probability that the CRM will be positive.<br>|
| Active Comparator: standard APR<br>conventional abdominoperineal resection (APR) | Procedure: APR<br>* standard Abdominoperineal Resection For Rectal Adenocarcinoma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurement of circumferential resection margin | Measurement in millimeters (mm) of the circumferential resection margin. | 0-10 minutes post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative time | operative time from skin incision to skin closure | 4-6 hours | 
| hospital stay | duration of hospital stay (defined as from beginning of surgery to time of discharge, measured in hours) | from beginning of surgery through discharge, usually 4-5 days | 
| estimated blood loss | estimated blood loss (ml) recorded by the anesthesiologist (not by the surgeon) | 4-6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rectal adenocarcinoma, Standard APR, Extralevator APR