Methods |
RCT
Multicenter
Sample size calculation
Conversion rate 29%
Intention to treat
Preoperative randomisation
Follow‐up 36.8 months (median) |
Participants |
n=794
Inclusion criteria: adenocarcinoma of the colon or rectum
Exclusion criteria:
Transverse colon cancer, contraindications to pneumoperitoneum (chronic cardiac or pulmonary disease), acute intestinal obstruction, malignant disease in the past 5 years, synchronous adenocarcinomas, pregnancy, associated gastrointestinal diseases needing surgical intervention. |
Interventions |
Laparoscopically‐assisted vs open
Tumour location:
colon or rectum
Type of resection: right or left
Adj. therapy: radiotherapy and chemotherapy were allowed at the physician`s discretion
Type of resection: left or right hemicolectomy, sigmoidectomy, anterior resection, APR |
Outcomes |
Adjuvant therapy, type of resection, localisation of the tumor, tumor stage, TME, number of positive resection margins, duration of follow‐up, local tumor recurrence, distant metastases, cancer‐related mortality. |
Notes |
Halpern and Preston quality score: 20 out of 22 |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |