A Randomized Trial of Laparoscopic versus Open Surgery for Rectal Cancer

Hoa Tang, Mercer University College of Pharmacy 2015

According to the Centers for Disease Control and Prevention (CDC), colorectal cancer is the second leading cause of cancer-related death in the United State. In 2011, over 135,000 people were diagnosed and more than 50,000 people died from colorectal cancer.1   Different types of treatment for patients with colon cancer include surgery, radiofrequency ablation, cryosurgery, chemotherapy, radiation therapy, and targeted therapy. The National Cancer Institute states that open surgery has been a standard treatment for patients with colon cancer. Laparoscopic surgery, which is a minimally invasive technique, is also a surgical option for patients with colorectal cancer.2

A recently published study compared three-year rates of locoregional recurrence between laparoscopic surgery and open surgery.3

Title: A Randomized Trial of Laparoscopic versus open Surgery for Rectal Cancer (COLOR II Trial)
Design Multicenter, randomized, open label, non-inferiority trial; N=1044
Objective To compare three-year rates of laparoscopic recurrence and survival after laparoscopic and open resection of rectal cancer
Study Groups Laparoscopic surgery group (N=699) versus open surgery group (N=345)
Methods Eligible patients were randomly assigned to 2:1 ratio to undergo either laparoscopic surgery or open surgery.
Duration January 2004 through May 2010; Follow up for 5 year after surgery
Primary Outcome Measure The primary endpoint was locoregional recurrence 3 years after the index surgery.

The secondary endpoints were disease-free and overall survival.

Baseline Characteristics Laparoscopic surgery group- mean age 66.8 years, male 64%, upper rectum tumor 32%, macroscopic completeness of resection 84%

Open surgery group- mean age 65.8 years, male 61%, upper rectum tumor 34%, macroscopic completeness of resection 88%

Results The three-year rate of locoregional recurrence: 5% in both laparoscopic and open surgery groups (90% confidence interval (CI), -2.6 to 2.6)

The three-year rate of disease-free survival: 74.8% in laparoscopic surgery group and 70.8% in open surgery group (95% CI, -1.9 to 9.9)

The overall survival rate: 86.7% in laparoscopic surgery group and 83.6% in the open surgery group (95% CI, -1.6 to7.8)

Adverse Events Common Adverse Events: not reported
Serious Adverse Events: not reported
Percentage that discontinued due to Adverse Events: not reported
Study Author Conclusions In conclusion, long-term outcomes of the COLOR II trial indicate that laparoscopic surgery is as safe and effective as open surgery in patients with rectal cancers without invasion of adjacent tissues.

This trial shows that three-year rates of locoregional recurrence in both laparoscopic group and open surgery group are no different. Moreover, the rates of disease-free survival and overall survival rates are similar between two groups. The American Society of Colon and Rectal Surgeons suggests that laparoscopic surgery may provide less discomfort, a shorter hospital stay and a shorter recovery time due to small incisions compared to open surgery.4  Therefore, laparoscopic surgery may be an acceptable surgical option for patients with rectal cancer if they qualify for it.


  1. Centers for Disease Control and Prevention (CDC). Colorectal Cancer Statistics. http://www.cdc.gov/cancer/colorectal/statistics/index.htm. Accessed April 8, 2015.
  2. National Cancer Institute. Colon Cancer Treatment. http://www.cancer.gov/cancertopics/pdq/treatment/colon/HealthProfessional. Accessed April 8, 2015.
  3. Bonjer HJ, Deijen CL, Abis GA, et al. A randomized trial of laparoscopic versus open surgery for rectal cancer. N Engl J Med. 2015;372(14):1324-32. http://www.nejm.org/doi/pdf/10.1056/NEJMoa1414882. Accessed April 7, 2015.
  4. American Society of Colon and Rectal Surgeons. Minimally Invasive Surgery Expanded Version. https://www.fascrs.org/patients/disease-condition/minimally-invasive-surgery-expanded-version. Accessed April 8, 2015.

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