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A Phase III Prospective Randomized Trial Comparing Laparoscopic-Assisted Resection Versus Open Resection for Rectal Cancer
Provider Data DescriptionThis dataset will allow users to reproduce the analysis for the primary publication in trial NCT00726622. This dataset is identical to NCT00726622-D1 except it also includes a patient reference (patref) field that can be tied to patient information submitted to NCTN Navigator submissions.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis study is being done to compare two types of surgery currently used for rectal cancer. The two types of surgery are laparoscopic-assisted rectal resection and open laparotomy rectal resection. Although laparoscopic-assisted rectal resection is being used for rectal cancer in some medical centers, the effectiveness of this type of surgery compared to open surgery is unknown. The study will compare the safety and effectiveness of the surgeries, recovery from surgery in the hospital, overall recovery from surgery and cancer outcome.
Intervention TypeProcedure: Open laparotomy and rectal resection Procedure: Laparoscopic-assisted rectal resection
Blinding MethodNone (Open Label)
Arms InterventionArm 1: Open laparotomy and rectal resection - Active Comparator Arm 2: Laparoscopic-assisted rectal resection - Experimental