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Laparoscopic-Assisted Resection or Open Resection in Treating Patients With Stage IIA, Stage IIIA, or Stage IIIB Rectal Cancer

2014-08-27 03:28:39 | BioPortfolio

Summary

RATIONALE: Laparoscopic-assisted resection is a less invasive type of surgery for rectal cancer and may have fewer side effects and improve recovery. It is not yet known whether laparoscopic-assisted resection is more effective than open resection in treating patients with rectal cancer.

PURPOSE: This randomized phase III trial is studying laparoscopic-assisted resection to see how well it works compared with open resection in treating patients with stage IIA, stage IIIA, or stage IIIB rectal cancer.

Description

OBJECTIVES:

Primary

- To test the hypothesis that laparoscopic-assisted resection is not inferior to open resection, based on a composite primary endpoint of oncologic factors that are indicative of a safe and feasible surgical resection, in patients with stage IIA, IIIA, or IIIB rectal cancer.

Secondary

- To compare the patient-related benefit of laparoscopic-assisted resection vs open resection, in terms of blood loss, length of stay, and utilization of pain medication.

- To compare the disease-free survival and local pelvic recurrence at 2 years.

- To compare the quality of life, sexual function, and bowel and stoma function.

OUTLINE: This is a multicenter study. Patients are stratified according to site of primary tumor (high vs middle vs low rectum), registering surgeon, and planned operative procedure (low anterior resection vs abdominal perineal resection). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo open laparotomy and rectal resection.

- Arm II: Patients undergo laparoscopic-assisted rectal resection. Quality of life is assessed periodically using EORTC Quality of Life Questionnaires (EORTC QLQ-C30 and -CR38), the Linear Analog Self-Assessment (LASA), the Stoma Quality of Life Scale (SQOLS), and the Mayo Bowel Function Questionnaire (MBFQ).

After completion of study treatment, patients are followed periodically for up to 5 years.

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Conditions

Colorectal Cancer

Intervention

therapeutic conventional surgery, therapeutic laparoscopic surgery

Location

Mayo Clinic Scottsdale
Scottsdale
Arizona
United States
85259-5499

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:28:39-0400

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Medical and Biotech [MESH] Definitions

Surgical procedures conducted with the aid of computers. This is most frequently used in orthopedic and laparoscopic surgery for implant placement and instrument guidance. Image-guided surgery interactively combines prior CT scans or MRI images with real-time video.

Procedures that avoid use of open invasive surgery in favor of closed or local surgery. These generally involve use of laparoscopic devices and remote-control manipulation of instruments with indirect observation of the surgical field through an endoscope or similar device. With the reduced trauma associated with minimally invasive surgery, long hospital stays may be reduced with increased rates of short stay or day surgery.

Procedures that avoid use of open, invasive surgery in favor of closed or local surgery. These generally involve use of laparoscopic devices and remote-controlled manipulation of instruments with indirect observation of the surgical field through an endoscope or similar device.

Moving a patient into a specific position or POSTURE to facilitate examination, surgery, or for therapeutic purposes.

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