| Methods |
RCT
sample size calculation;
intraoperative randomisation after diagnostic laparoscopy;
conversions analysed as
intention to treat |
| Participants |
n = 109
Inclusion: right sided or sigmoid cancer, upper rectal cancer, lower rectal cancer requiring APR.
Exclusion: emergency or urgent surgery, disseminated disease, infiltration of adjacent organs, tumor > 8cm in diameter, transverse or descending colon tumors, midrectal tumors, BMI > 32 kg/m², declined to participate, dense adhesions, bowel distension, pregnancy, cardiovascular problems, refusal of insurance to pay for laparoscopic surgery |
| Interventions |
laparoscopic vs. conventional
Conversions: adhesions 4.
Tumor location: ascending colon, sigmoid, upper rectum, lower rectum.
Type of resection: right colon 29 vs. 26, left colon and ant. rectal resection 19 vs. 24, APR 7 vs. 4.
Tumor stage: UICC I 10 vs. 9,
UICC II 13 vs. 11, UICC III 16 vs. 14, UICC IV 3 vs. 4. |
| Outcomes |
Main study criterium: pulmonary function.
Data given for: operative time, analgetics, duration of ileus, morbidity, hospital stay. |
| Notes |
Laparoscopic technique: gas insufflation.
Conventional incision: midline incision.
Anesthesia/Analgesia: standardized, systemic pca;
Analgetic drugs: morphine.
Evans & Pollock: Design 33, Analysis 23,
Presentation 18, Total 74. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
