Laparoscopic-Assisted Resection or Open Resection in Treating Patients With Rectal Cancer
Colorectal Cancer

About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring rectal cancer, adenocarcinoma of the rectum
Eligibility Criteria
Eligibility Criteria:
- Histologic diagnosis of adenocarcinoma of the rectum (≤ 12 cm from the anal verge)
- T3, N0, M0, T1-3, N1-2, M0 disease as determined by pre-neoadjuvant therapy CT scans and pelvic MRI or transrectal ultrasound. Patients with T4 disease are not eligible.
- Completion of pre-operative 5FU based chemotherapy and/or radiation therapy. Capecitabine may be substituted for 5FU.
- Age ≥ 18 years
- ECOG (Zubrod) Performance Status ≤ 2
- Body Mass Index (BMI) ≤ 34
- No evidence of conditions that would preclude use of a laparoscopic approach (eg, multiple previous major laparotomies, severe adhesions)
No systemic disease (cardiovascular, renal, hepatic) that would preclude surgery. No other severe incapacitating disease:
- ASA IV: A patient with severe systemic disease that is a constant threat to life. OR
- ASA V: A moribund patient who is not expected to survive without the operation.
- No concurrent or previous invasive pelvic malignancy (cervical, uterine and rectal) within five years prior to registration
- No history of psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
NOTE: Incompetent patients are not eligible for this trial.
Sites / Locations
- Mayo Clinic Scottsdale
- Cancer Care Center at John Muir Health - Concord Campus
- Kaiser Permanente Medical Center - Los Angeles
- California Pacific Medical Center - California Campus
- John Muir/Mt. Diablo Comprehensive Cancer Center
- Cleveland Clinic Florida - Weston
- John B. Amos Cancer Center
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
- Evanston Hospital
- Clarian North Medical Center
- Indiana University Melvin and Bren Simon Cancer Center
- Veterans Affairs Medical Center - Indianapolis
- William N. Wishard Memorial Hospital
- Kendrick Regional Center for Colon and Rectal Care - Mooresville
- Holden Comprehensive Cancer Center at University of Iowa
- Lahey Clinic Medical Center - Burlington
- Blodgett Hospital at Spectrum Health
- Mayo Clinic Cancer Center
- Boone Hospital Center
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
- Overlook Hospital
- Memorial Sloan-Kettering Cancer Center
- Stony Brook University Cancer Center
- SUNY Upstate Medical University Hospital
- Duke Cancer Institute
- Cleveland Clinic Taussig Cancer Center
- INTEGRIS Cancer Institute of Oklahoma - Proton Campus
- Providence Cancer Center at Providence Portland Medical Center
- Forbes Regional Hospital
- Allegheny Cancer Center at Allegheny General Hospital
- Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
- Lankenau Cancer Center at Lankenau Hospital
- M. D. Anderson Cancer Center at University of Texas
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
- Medical College of Wisconsin Cancer Center
- St. Paul's Hospital at Providence Health Care - Vancouver
- St. Joseph's Hospital - Charlton Campus
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm 1: Open laparotomy and rectal resection
Arm 2: Laparoscopic-assisted rectal resection
Patients undergo open laparotomy and rectal resection. The standard form of surgery is open laparotomy rectal resection. During open laparotomy, the surgeon makes a large incision or cut in the abdomen, and goes in through that cut to remove the tumor and lymph nodes from the rectum.
Patients undergo laparoscopic-assisted rectal resection. Laparoscopic-assisted rectal resection is performed using small instruments on long handles introduced into the abdomen through small ports called trocars in 3 - 6 positions on the abdomen through incisions measuring 5 -10 mm, under the guidance of a video camera. The abdominal wall is held up with carbon dioxide under pressure. The piece of bowel or intestine is removed through another incision (about 8 centimeters), and the ends of the intestine are reconnected to provide normal bowel function.