CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 486 enrolled
Drug / intervention
Open laparotomy and rectal resection +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00726622
NCT00726622Phase 3Completed

A Phase III Prospective Randomized Trial Comparing Laparoscopic-Assisted Resection Versus Open Resection for Rectal Cancer

Alliance for Clinical Trials in Oncology·interventional·Posted Aug 1, 2008·Updated May 7, 2020

In Brief

A Phase 3 clinical trial evaluating Open laparotomy and rectal resection and Laparoscopic-assisted rectal resection for Colorectal Cancer. Completed, enrolled 486 participants across 37 sites in 2 countries.

Detailed Summary

This 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States

Timeline

Phase 3CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 1, 2008
Enrollment StartAug 1, 2008
Primary CompletionOct 1, 2013
Study CompletionAug 1, 2019
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 17.9 years ago

Interventions

Open laparotomy and rectal resectionprocedure

Patients undergo open laparotomy and rectal resection.

Laparoscopic-assisted rectal resectionprocedure

Patients undergo laparoscopic-assisted rectal resection.