NCT03837782

Outcome of Resection for Colorectal Cancer

Minimally Invasive Versus Abdominal Radical Resection for Colorectal Cancer

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,300 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

There are limited data from retrospective studies regarding whether short-term and long-term outcomes after laparoscopic or robot-assisted radical colectomy (minimally invasive surgery) are equivalent to those after open abdominal radical colectomy (open surgery) among patients with early and medium-stage colorectal cancer. This trial is a multicenter,prospective, randomized trial evaluating short-term and survival outcomes concerning minimally invasive surgery and open surgery for colorectal cancer.

Detailed description

Radical colectomy and proctectomy with regional lymphadenectomy remain the standard recommendation for patients with early and medium-stage colorectal cancer. Current guidelines from the National Comprehensive Cancer Network indicate that either laparotomy (open surgery) or laparoscopy (minimally invasive surgery performed with either conventional or robotic techniques) is an acceptable approach to radical resection in patients with early- and medium stage (I to III) colorectal cancer. These recommendations have led to widespread use of a minimally invasive approach for radical resection, although there is a paucity of adequately powered, prospective, randomized trials evaluating short term and survival outcomes. Retrospective studies involving patients with early and medium-stage colorectal cancer have shown that laparoscopic resection is associated with less intraoperative blood loss, a shorter length of hospital stay, and a lower risk of postoperative complications than open abdominal radical resection. Similarly, the minimally invasive approach has not been associated with lower 5-year rates of disease-free survival or overall survival than the open approach. In addition, retrospective studies have shown that recurrence rates and survival rates do not differ significantly between the two approaches. The investigators hypothesized that minimally invasive surgery was not inferior or superior to open radical resection in terms of short-term and long-term outcome. In the present trial, the Laparoscopic Resection and Laparotomy for Colorectal Cancer (LRLCC) Trial, the investigators tested this hypothesis by prospectively assigning patients to minimally invasive (conventional laparoscopic or robotic) or open abdominal radical surgery and comparing the short-term outcome, the rate of recurrence, and the overall survival rate between the two groups.

Conditions

• Laparoscopy

Interventions

Type	Name	Description
PROCEDURE	minimally invasive surgery	Each participating site required accreditation by the trial management committee to ensure proper surgical technique during minimally invasive surgery. No individual surgeons performed only the open approach or only the minimally invasive approach. The committee members reviewed the patients' outcomes and the videos to ensure the adequacy of the surgeon's technique.

Timeline

• Start date: 2019-02-15
• Primary completion: 2019-11-01
• Completion: 2026-12-01
• First posted: 2019-02-12
• Last updated: 2019-02-12

Locations

1 site across 1 country: China