Burke 1994.
| Methods | Stated that randomised, but no details provided about randomisation method.
Blinding: single‐blind: surgeons were aware of participants' bowel preparation.
Withdrawal/dropout: 31% withdrew (17/186), there were no dropouts.
Follow up: not related. On a day 7 before surgery, the colorectal anastomosis was checked, in the first half of the series. |
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| Participants | Inclusion criteria: participants admitted for elective colorectal surgery with primary anastomosis. Exclusion criteria: any participants who could not tolerate the preparation; participants who had the bowel "prepared" for another procedure within previous week. Diseases: 72% colorectal cancer (133/186); 3% inflammatory bowel disease (6/186); 14% diverticular disease (26/186); 2% other (4/186). Number: 186 (95 male; 74 female; 17 undetermined). Age: mean age 64 years. Location of study: Dublin, Ireland. Date: October 1988‐September 1992. Antibiotics: Ceftriaxone 1 g + metronidazole 500 mg intravenously started at induction of anaesthesia. Metronidazole 500 mg: 8 and 16 h, after initial dose. | |
| Interventions | Group A ‐ MBP group (n = 82): sodium picosulphate 10 mg, the day before surgery (dose in morning and afternoon). Group B ‐ normal diet and no other bowel preparation (n = 87). | |
| Outcomes | Death: Group A =2; Group B = 0. Cardiorespiratory complications: Group A = 8; Group B = 9. Wound infection: Group A = 4; Group B = 3. Anastomotic dehiscence: Group A = 3; Group B = 4. Reoperation: Group A = 2; Group B = 4. | |
| Notes | Representative sample: consecutive participants.
Surgical procedures that were excluded: participants submitted to Hartman's resection (Group A = 5: Group B = 5); defunctioning colostomy (Group A = 0: Group B = 2); abdominal excision of the rectum (Group A = 1: Group B = 2); coloanal anastomosis with colostomy (Group A = 0: Group B = 1); colostomy for rectal polyp (Group A = 1: Group B = 0).
All surgery was performed by one of two consultant surgeons or a senior registrar.
Participants without anastomosis were excluded. The outcome "Anastomotic leakage" was stratified, by the author: Left colectomy: Group A = 43; Group B = 51. Anterior resection: Group A = 39; Group B = 36. Anastomotic leakage/low anterior resection: Group A = 3/39; Group B = 4/36. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |