| Methods |
RCT
Multicenter
Sample size calculation
Preoperative randomisation
Number of patients not randomised: unclear
Conversion rate 21%
Intention to treat
Follow‐up: 4.4 years (median) |
| Participants |
n=863
Inclusion criteria: adenocarcinoma of the colon, age of at least 18 years, absence of prohibitive abdominal adhesions
Exclusion criteria: advanced local or metastatic disease, rectal or transverse colon cancer, acute bowel obstruction or perforation from cancer, severe medical illness, inflammatory bowel disease, pregnancy, concurrent or previous malignant tumour
Seven patients were excluded after randomisation due to the fact that they did not receive the allocated treatment. |
| Interventions |
Laparoscopically assisted vs open Tumour location: left, right or sigmoid colon
Adj. therapy: postoperative chemotherapy was allowed at the physician`s discretion
Type of resection: right or left hemicolectomy, sigmoidectomy |
| Outcomes |
Tumor localisation, tumor stage, number of lymph nodes harvested, duration of follow‐up, recurrence free survival and overall survival |
| 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 |
