Rectal Adenocarcinoma
Conditions
Keywords
rectal adenocarcinoma, Standard APR, Extralevator APR
Brief summary
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.
Interventions
PROCEDUREextralevator APR
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.
PROCEDUREAPR
standard Abdominoperineal Resection For Rectal Adenocarcinoma
Sponsors
Stony Brook University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| measurement of circumferential resection margin | 0-10 minutes post surgery | Measurement in millimeters (mm) of the circumferential resection margin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| operative time | 4-6 hours | operative time from skin incision to skin closure |
| hospital stay | from beginning of surgery through discharge, usually 4-5 days | duration of hospital stay (defined as from beginning of surgery to time of discharge, measured in hours) |
| estimated blood loss | 4-6 hours | estimated blood loss (ml) recorded by the anesthesiologist (not by the surgeon) |
Countries
United States
Contacts
Primary ContactRoberto Bergamaschi, MD, PhD
Backup ContactEileen Finnin, RN
Outcome results
None listed