Schulze 1992.
Methods | RCT Approved by the ethics committee and written informed consent obtained Setting: Denmark Funding: charity |
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Participants | 25 patients aged 67 to 79 years undergoing elective left‐side colonic resection Exclusion criteria were signs of endocrinological, renal, hepatic, immunological or severe cardiopulmonary disease or infection within 2 weeks before the operation |
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Interventions |
Treatment group: thoracic epidural analgesia with lidocaine for surgery and bupivacaine plus morphine for 48 hours after surgery plus intrathecal 5% lidocaine and 30 mg/kg of methylprednisolone IV before surgery plus routine systematic indomethacin after surgery (n = 11) Control group: intermittent morphine and acetaminophen on request (n = 9) |
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Outcomes | Time to first faeces Pain at rest and during coughing at 6, 24, 48 and 72 hours Gastointestinal anastomotic leakage Length of hospital stay |
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Notes | Email sent 30 May 2016, for additional information; study authors replied that data are no longer available; therefore, we could extract only gastrointestinal leakage data | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomized", no details |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not mentioned |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not mentioned |
Incomplete outcome data (attrition bias) All outcomes | High risk | Excluded if blood losses exceeded 1 L, or if left colonic flexure mobilization was required Five participants were excluded ‐ 2 because of excessive bleeding (> 1 L), 2 because of excessive surgery due to tumour invasion and 1 because no tumour was found at operation |
Selective reporting (reporting bias) | Low risk | All results reported |
Other bias | High risk | Treatment group also received a high dose of steroid and routine systemic co‐analgesia Not in intention‐to‐treat |