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Title:

A Phase III Prospective Randomized Trial Comparing Laparoscopic-assisted Resection Versus Open Resection for Rectal Cancer ACOSOG Z6051

Protocol Number:

ACOSOGZ6051

Phase:

Phase III

Physician:

Jonathan Efron

Purpose:

To compare laparoscopic-assisted surgery of rectal cancer to open rectal surgery. And to assess: patient-related benefit of laparoscopic-assisted surgery of rectal cancer vs. open rectal surgery (blood loss, length of stay, pain medicine utilization), disease free survival and local pelvic recurrence at two years, quality of life, sexual function, bowel and ostomy function at scheduled time points throughout the trial.

Eligibility:

Adults greater than 18 years of age who have confirmed diagnosis of cancer of the rectum. Completion of pre-operative chemotherapy and/or radiation therapy. Body Mass Index (BMI) less than 34. No multiple previous major abdominal surgeries. No systemic disease (cardiovascular, renal, hepatic, etc.) that would exclude the surgery. A patient with severe systemic disease that is a constant threat to life or a moribund patient who is not expected to survive without the operation is not eligible. No concurrent or previous invasive pelvic malignancy (cervical, uterine and rectal) within five years prior to registration. No history of psychiatric or addictive disorders.

Treatment:

Patients will be divided into one of the following treatment arms for treatment purposes: _ Arm 1: Open rectal surgery _ Arm 2: Laparoscopic-assisted rectal surgery

Population:

Adult

Last Update

05/22/2013 04:02 AM

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