Methods |
RCT
Single centre
No sample size calculation
Preoperative randomisation
Number of patients not randomised: unclear
Conversion rate 15%
Conversions were analysed in the open arm of the trial
Follow‐up 30.1 months (mean) |
Participants |
n=37
Inclusion criteria: adenocarcinoma of the right, left, or sigmoid colon, 18 years of age or older, able to participate in close follow‐up evaluations postoperatively
Exclusion criteria: prohibitive scars from previous abdominal surgery, advanced local disease, stage IV colon cancer, rectal cancer, acutely perforated or obstructing cancers, cancers of the transverse colon, ASA IV or V, associated gastrointestinal diseases requiring extensive operative intervention, concurrent or previous malignant tumour within 5 years (excl. non melanoma skin cancer), pregnancy
Six patients were lost to follow‐up. |
Interventions |
Laparoscopic vs open
Tumour location: right, left, or sigmoid colon
Adj. therapy: postoperative chemotherapy according to tumour stage and other patient‐related factors, no postoperative radiation
Type of resection: Right or left hemicolectomy, sigmoidectomy |
Outcomes |
Adjuvant therapy, tumor localisation, duration of follow‐up, incidence of incisional hernia, reoperations for incisional hernia |
Notes |
Halpern and
Preston
quality score: 15 out of 22 |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |