Rectal cancer
Conditions
Interventions
Transanal Total Mesorectal Excision.
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Solitary adenocarcinoma rectal cancer within 10 cm from anal verge defined by MRI 2) Stage 1-3 based on AJCC classification including downstaged tumours 3) Intention for LAR with colorectal anastomosis or with coloanal anastomosis 4) Suitable for elective laparoscopic surgical resection 5) Informed consent according to local requirements
Exclusion criteria
Exclusion criteria: 1) T3 tumour with margins less than 1 mm to the mesorectal fascia or T4 tumour, determined by MRI-scan (staged after (chemo)radiotherapy if applicable) 2) Intention for complete intersphincteric APR with coloanal anastomosis 3) Malignancy other than adenocarcinoma at histological examination 4) Patients under 18 years of age 5) Pregnancy 6) Previous prostate or rectal surgery (excluding local excision) 8) Signs of acute intestinal obstruction 9) Multiple colorectal tumours 10) Familial Adenomatosis Polyposis Coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), active Crohn*s disease or active ulcerative colitis 11) Planned synchronous abdominal organ resections 14) Other malignancies in medical history, except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri 15) Absolute contraindication to general anaesthesia or prolonged pneumoperitoneum, as severe cardiovascular or respiratory disease (ASA class > III)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the percentage of patients with local recurrence after 3-years follow-up. (defined as local macroscopic tumour assessed by colono- or proctoscopy, (PET-)CT-scan or MRI of the pelvis) | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological • Quality of specimen (as proposed and published by Quirke et al.) • Involved circumferential resection margin • Distal resection margin (defined as distance in cm from distal border of the tumour to distal resection surface) • Translational research will be performed on predictive/prognostic biomarkers and imaging methods. Clinical • Length of hospital stay postoperatively (calculated as time from surgery to discharge in days) • Morbidity within 28 days after surgery and within 90 days (graded by Clavien-Dindo Classification) • Mortality within 28 days after surgery and within 90 days • Local recurrence at three and five years (defined as cancer recurrence within the pelvic and perineal area) • Disease-free survival at three and five years (calculated as time from surgery to last follow- up or date of recurrence) • Overall survival at three and five years (calculated as time from surgery to last follow- up or death) Quality of life • Percentage of sphincter saving procedures (defined as colostomy percentage at 1 year postoperatively) • Postoperative health related quality of life (quality adjusted life years) and functional outcome (measured with EORTC QLQ-CR29 and C30, EQ5D and LARS score). | — |
Countries
Netherlands
Outcome results
None listed