Eatock 2005.
Methods | Randomised, parallel‐group, open‐label, 2‐armed, active‐controlled trial Setting: Tertiary care hospital Trial duration: October 1997 to July 2000 |
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Participants |
Number randomised: 27 (NG), 23 (NJ)
Number analysed: 27 (NG), 23 (NJ)
Age: NG feed: 63 years (47 to 74), NJ feed: 58 years (48 to 64)
Gender (M/F): NG feed: 14/13, NJ feed: 13/10 Inclusion criteria: Patients with severe acute pancreatitis Definition of pancreatitis: Abdominal pain and serum amylase >= 3 times the upper limit of reference range Scale of severity used: Glasgow score >= 3, APACHE II >= 6, CRP > 150 mg/L Exclusion criteria:
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Interventions |
Intervention: NG feed (N = 27), tube in stomach
Control: NJ feed (N = 22), tube in proximal jejunum Feeding starts ‐ hours form onset of pain: 72 (NG), 72 (NJ) Interval to full rate of feed ‐ hours after feeding commenced: 36 (NG), 36 (NJ) Type of feed used: low‐fat semi‐elemental Method of insertion: bedside (NG), endoscopic (NJ) Confirmation of correct position: aspiration and pH measurement or X‐ ray (NG), endoscopy (NJ) Endoscopy treatment: ES (endoscopic sphincterotomy) in 7 NG and 9 NJ Surgical treatment: not reported Treatment supervised: yes |
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Outcomes |
Outcomes sought and reported
Outcomes sought but not reported
Outcomes not sought but reported
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Notes |
Country: Scotland Funding source: Not reported Conflicts of interest: Not reported 1 randomised participant in NJ group was subsequent discovery of an incorrect diagnosis of acute pancreatitis. Feeding tube could not be passed into jejunum in 2 participants in the NJ group; they received NG feed but were analysed as ITT (NJ group). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote from report, "Randomization was by computerized random number generation" |
Allocation concealment (selection bias) | Unclear risk | Quote from report, "... sequence was implemented using numbered containers." Comment: It is unclear from the report if the containers were opaque and sequentially numbered. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote from report, "... No blinding of participants or investigators was attempted." Comment: This was an open‐label study, but there were no differences in co‐interventions between groups. |
Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Although this was an open‐label study, objective outcomes were unlikely to have been affected by detection bias. |
Blinding of outcome assessment (detection bias) Subjective outcomes (pain) | Unclear risk | This was an open‐label study, and the detection of pain using the VAS could potentially have been affected by knowledge of the intervention. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcome data were available for all participants, and analysis was by intention‐to‐treat. |
Selective reporting (reporting bias) | Low risk | The trial was not prospectively registered, and no study protocol was available, but the pre‐stated outcomes in the methods were reported. |
Other bias | Unclear risk | Source of funding and conflicts of interest were not mentioned. |