Mennigen 1989.
Methods | Sequence generation: random number tables Allocation concealment: not described Blinded: not described |
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Participants | Inclusion criteria: elective resection, intra‐abdominal anastomosis Exclusion criteria: obstruction, perforation or sepsis present at time of performing anastomosis, i.e. emergency operation Type of disease: 77/100 carcinoma, 6/100 adenoma, 7/100 diverticular disease, 9/100 inflammatory colon disease, 1/100 type of disease not reported (for 1 drop‐out) Type of anastomosis: 59/100 left hemicolectomy, 33/100 right hemicolectomy, 7/100 subtotal colectomy, 1/100 not described Number of participants: 100 Age range: 15‐87 years Gender: 49 male, 50 female Place of study: Germany (single centre) Time of study: June 1984 to November 1986 |
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Interventions | Treatment: silicone drain Control: no drain |
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Outcomes | Primary outcome: anastomotic dehiscence Secondary outcomes: mortality, surgical re‐intervention, radiological anastomotic dehiscence and wound infection |
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Notes | Publication: journal article | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number tables |
Allocation concealment (selection bias) | Unclear risk | No description |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Unclear |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No description |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No description |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Drop‐out 1/100 (1%) |
Selective reporting (reporting bias) | Low risk | Reported all outcomes that were pre‐stated in the methods section |
Other bias | Unclear risk | No studies reported substantial baseline differences in the treatment and control groups. We found no other potential sources of bias within the included studies Sample size calculation not described. Source of bias |