Fillmann 1995.
| Methods | Randomisation: no details.
Blinding: double‐blind (orange juice for the control group; no details about blinding the surgeons).
Withdrawals/dropouts: no withdrawals or dropouts. Follow up: 30 days after surgery. |
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| Participants | Inclusion criteria: participants admitted for elective colorectal surgery with primary anastomosis.
Exclusion criteria: no exclusions.
Diseases (Group A/B): colorectal cancer (22/21); diverticular disease (5/6); inflammatory bowel disease (2/3); ischemics colitis (1/0).
Number: 60 (33 male; 27 female).
Age: 31‐82 years.
Location: Porto Alegre, RS, Brazil.
Date: 1992‐1993. Antibiotics: metronidazole + gentamicin 1 h before surgery, and then for 48 h. |
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| Interventions | Group A ‐ MBP (n = 30): 500 ml mannitol 20% + 500 ml orange juice. Group B ‐ orange juice (n = 30). | |
| Outcomes | Wound infection: Group A = 1; Group B = 2.
Peritonitis: Group A = 2; Group B = 1.
Extra‐abdominal complications (non‐infectious): ‐Mechanical obstruction: Group A = 0; Group B = 1. ‐Dehiscence of wall suture: Group A = 0; Group B = 1. ‐Pulmonary embolism: Group A = 1; Group B = 0. Extra‐abdominal complications (infections): ‐Pneumonia: Group A = 1; Group B = 1. ‐Urinary infection: Group A = 1; Group B = 2. |
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| Notes | The sample size was calculated, but no details given. Included participants without anastomosis. Recurrence was not mentioned. No deaths in this trial. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | A ‐ Adequate |