COLOR II: Laparoscopic Versus Open Rectal Cancer Removal

COLOR II is a randomized, international, multi center study comparing the outcomes of laparoscopic and conventional resection of rectal carcinoma below 15 cm with curative intent. Clinical and operative data will be collected centrally in the coordinating centre in Halifax, Canada. Quality of life and costs will be assessed on a national basis.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* solitary rectal cancer observed at colonoscopy or on barium X-ray
* no evidence of distant metastases
* distal border of the tumor within 15 cm of the anal verge at rigid rectoscopy or under linea conjugata at lateral barium enema radiography
* suitable for elective surgical resection
* informed consent

Exclusion Criteria:

* T1 tumors treated by locl excision
* T4 tumors
* patients under 18 years of age
* signs of acute intestinal obstruction
* more than one colorectal tumor
* Familial Adenomatosis Polyposis, Hereditary Non-Polyposis Colorectal Cancer
* active crohn's or active ulcerative colitis
* scheduled need for other synchronous colon surgery
* preoperative indication of invasion of adjacent organs, immobile at palpation or CT showing invasion
* preoperative evidence of metastases (at least chest X-ray and liver ultrasound)
* other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri
* absolute contraindications to general anesthesia or prolonged pneumoperitoneum (ASA class \> III)
* pregnancy

• DERIVEDAndersson J, Angenete E, Gellerstedt M, Haglind E. Developing a multivariable prediction model of global health-related quality of life in patients treated for rectal cancer: a prospective study in five countries. Int J Colorectal Dis. 2024 Mar 5;39(1):35. doi: 10.1007/s00384-024-04605-y. PMID 38441657
• DERIVEDKoedam TWA, Bootsma BT, Deijen CL, van de Brug T, Kazemier G, Cuesta MA, Furst A, Lacy AM, Haglind E, Tuynman JB, Daams F, Bonjer HJ; on behalf of the COLOR COLOR II study group. Oncological Outcomes After Anastomotic Leakage After Surgery for Colon or Rectal Cancer: Increased Risk of Local Recurrence. Ann Surg. 2022 Feb 1;275(2):e420-e427. doi: 10.1097/SLA.0000000000003889. PMID 32224742
• DERIVEDPetersson J, Koedam TW, Bonjer HJ, Andersson J, Angenete E, Bock D, Cuesta MA, Deijen CL, Furst A, Lacy AM, Rosenberg J, Haglind E; COlorectal cancer Laparoscopic or Open Resection (COLOR) II Study Group. Bowel Obstruction and Ventral Hernia After Laparoscopic Versus Open Surgery for Rectal Cancer in A Randomized Trial (COLOR II). Ann Surg. 2019 Jan;269(1):53-57. doi: 10.1097/SLA.0000000000002790. PMID 29746337
• DERIVEDBonjer HJ, Deijen CL, Abis GA, Cuesta MA, van der Pas MH, de Lange-de Klerk ES, Lacy AM, Bemelman WA, Andersson J, Angenete E, Rosenberg J, Fuerst A, Haglind E; COLOR II Study Group. A randomized trial of laparoscopic versus open surgery for rectal cancer. N Engl J Med. 2015 Apr 2;372(14):1324-32. doi: 10.1056/NEJMoa1414882. PMID 25830422
• DERIVEDAndersson J, Abis G, Gellerstedt M, Angenete E, Angeras U, Cuesta MA, Jess P, Rosenberg J, Bonjer HJ, Haglind E. Patient-reported genitourinary dysfunction after laparoscopic and open rectal cancer surgery in a randomized trial (COLOR II). Br J Surg. 2014 Sep;101(10):1272-9. doi: 10.1002/bjs.9550. Epub 2014 Jun 12. PMID 24924798
• DERIVEDAndersson J, Angenete E, Gellerstedt M, Angeras U, Jess P, Rosenberg J, Furst A, Bonjer J, Haglind E. Health-related quality of life after laparoscopic and open surgery for rectal cancer in a randomized trial. Br J Surg. 2013 Jun;100(7):941-9. doi: 10.1002/bjs.9144.