Extralevator Versus Standard Abdominoperineal Resection For Rectal Adenocarcinoma

Stony Brook University34 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Rectal Adenocarcinoma

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

State University Hospital Medical Center

Stony Brook, New York, United States

RECRUITING

Stony Broook University Medical Center

Stony Brook, New York, United States

RECRUITING

Stony Brook University Medical Center

Stony Brook, New York, United States

RECRUITING

Stony Brook University Medical Center

Stony Brook, New York, United States

RECRUITING

Outcomes

Primary Outcomes

measurement of circumferential resection margin

Measurement in millimeters (mm) of the circumferential resection margin.

Time frame: 0-10 minutes post surgery

Secondary Outcomes

operative time

operative time from skin incision to skin closure

Time frame: 4-6 hours

hospital stay

duration of hospital stay (defined as from beginning of surgery to time of discharge, measured in hours)

Time frame: 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)

Time frame: 4-6 hours

Extralevator Versus Standard Abdominoperineal Resection For Rectal Adenocarcinoma

Overview

Conditions

Interventions

Eligibility

Locations (4)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts