Fa‐Si‐Oen 2005.
| Methods | Central trial office of randomisation, computer generated. Concealment OK. Blinding: not described. Withdrawal/dropout: no exclusions. Follow up: 3 months. | |
| Participants | Inclusion criteria: elective colon surgery. Exclusion criteria: previous radiotherapy and/or chemotherapy; idiopathic inflammatory bowel disease; obstructive tumours; emergency laparotomy; MBP one week before the surgery; ileocaecal resections and resections below the peritoneal reflection. Diseases: recurrent diverticular disease, colon malignancy, other. Number: 250 (114 male; 136 female). Age: 27.7‐89.0 years. Location: 5 centres in the Netherlands (4) and Belgium (1). Date: 1 October 1998‐1 October 2002. Antibiotics: cefazolin (2 g) + metronidazole (1.5 g) or gentamicin (240 mg) + metronidazole (1.5 g), 30 minutes before surgery. | |
| Interventions | Group A ‐ MBP (n = 125): 4 litres of PEG. Group B ‐ normal meal up to ten hours before surgery (n = 125). | |
| Outcomes | Anastomotic leakage: Group A = 7, Group B = 6;
Wound infection: Group A = 9, Group B = 7. Reoperation: Group A = 13, Group B = 11. |
|
| Notes | Primary data. Multicentre study. Sample size was calculated. All participants were included as intention to treat. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | A ‐ Adequate |