COLOR III Trial: Transanal vs Laparoscopic TME

Launched by AMSTERDAM UMC, LOCATION VUMC · Apr 7, 2016

Keywords

ClinConnect Summary

To improve oncological and functional outcomes of patients with rectal cancer new surgical techniques are being developed. The adoption of the TME technique has resulted in better oncological outcome in the last decades. The addition of neoadjuvant therapy has further improved oncological outcome. The minimal invasive laparoscopic resection of rectal cancer has shown to be safe and to result in improved short-term outcomes and reduced morbidity.

Nevertheless, the laparoscopic resection of mid and low rectal cancer remains challenging due to the anatomy of the narrow pelvis and is associate...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Solitary mid (5.1-10cm from anal verge on MRI) or low (0-5cm from anal verge on MRI) rectal cancer observed at colonoscopy and histologically proven through biopsy
• • Distal border of the tumour within 10cm from the anal verge on MRI-scan
• • Tumour with threatened margins downstaged after neoadjuvant therapy to free margins
• • No evidence for distal metastases on imaging of thorax and abdomen
• • Suitable for elective surgical resection
• • Informed consent according to local requirements
• Exclusion Criteria:
• • T3 tumours with margins less than 1mm to the MRF, determined by MRI-scan (as staged after preoperative chemo- and/or radiotherapy)
• • T4 tumours, as staged after preoperative chemo- and/or radiotherapy
• • Tumours with in growth more than 1/3 of anal sphincter complex or levator ani
• • Malignancy other than adenocarcinoma at histological examination
• • Patients under 18 years of age
• • Pregnancy
• • Previous rectal surgery (excluding local excision, EMR (endoscopic mucosal resection) or polypectomy)
• • Signs of acute intestinal obstruction
• • Multiple colorectal tumours
• • Familial Adenomatosis Polyposis Coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), active Crohn's disease or active ulcerative colitis
• • Planned synchronous abdominal organ resections
• • Preoperative suspicion of invasion of adjacent organs through MRI-scan
• • Preoperative evidence for distant metastases through imaging of the thorax and abdomen
• • 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 anaesthesia or prolonged pneumoperitoneum, as severe cardiovascular or respiratory disease (ASA class \> III)