Scabini 2010.
| Methods | Randomisation: patients were prospectively randomised by individual computer‐generated randomisation into two groups. Blinding: not described. Withdrawal/dropout: 62 patients were excluded after randomisation due to the exclusion criteria. Duration of follow‐up: 30 days postoperative. |
|
| Participants | Inclusion criteria: patients undergoing elective colon and rectal surgery with primary anastomosis. Exclusion criteria: abdominal perineal resection, transanal resection for T1, total mesorectal excision with sphincter saving procedure after neo‐adjuvant therapy for middle or low rectal cancer, R2‐ resection, randomisation in other studies, urgency or emergency procedures, patients who required a diverting stoma proximal to the anastomosis and those who were found to have an abdominal abscess at the time of surgery. Diseases: colorectal cancer. Number of participants: 244 (125 male; 110 female). Age: 60 ‐ 80 years. Location of study: Oncologic Unit Surgery, San Martino Hospital, Genoa, Italy. Time of study: 2005 (July) ‐ 2009 (September). Antibiotics: cephalosporin 2 g + metronidazole 500 mg. |
|
| Interventions | Group A ‐ MBP (n = 120): 12 to 16 hours before surgery with polyethylene glycol. Group B ‐ no MBP (n = 124). Patients undergoing rectal surgery were given one enema one day before surgery. |
|
| Outcomes | Anastomotic leakage: Group A = 7, Group B = 5. ‐ Colon: Group A = 2, Group B = 2. ‐ Rectum: Group A = 5, Group B = 3. Wound infection: Group A = 11, Group B = 6. Abdominal abscess: Group A = 6, Group B = 3. Total of infectious complications: Group A = 24, Group B = 14. |
|
| Notes | Surgery localization: ‐ Colon: Group A = 87, Group B = 95. ‐ Rectum (upper): Group A = 33, Group B = 29. Surgical procedure: ‐ Right colectomy: Group A = 40, Group B = 50. ‐ Transverse colectomy: Group A = 9, Group B = 4. ‐ Left colectomy: Group A = 13, Group B = 26. ‐ Sigmoidectomy: Group A = 25, Group B = 15. ‐ Anterior resection: Group A = 33, Group B = 29. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | A ‐ Adequate |