Singh 2012.
Methods | Randomised, parallel‐group, open‐label, 2‐armed, non‐inferiority, active‐controlled trial Settings: Hospital in India Duration of trial: January 2005 to December 2007 |
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Participants |
Number randomised: 78 (NG 39, NJ 39)
Number analysed: 78 (NG 39, NJ 39)
Age: NG feed: 39.1 ± 16.7 years, NJ feed: 39.7 ± 12.3 years
Gender (M/F): NG feed: 28/11, NJ feed: 25/14 Inclusion criteria: All patients with SAP admitted within 7 days of onset of pain were included Definition of pancreatitis: Diagnosis was based on clinical features, raised amylase levels (3 times the reference), and evidence of acute pancreatitis on imaging studies, namely, ultrasonography and/or contrast enhanced computed tomographic scan of the abdomen Scale of severity used: Severe AP was defined by at least 1 of the following criteria:
Scale of severity used: Standard criteria for diagnosis APACHE, CTSI, or Atlanta (organ failure) Exclusion criteria:
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Interventions |
Intervention: NG feed (N = 39), tube placed in stomach
Control: NJ feed (N = 39), tube placed in jejunum beyond ligament of Treitz Days after admission the feeding was initiated: attempted to start feeding after 48 hours of admission Days after admission the adequate calorie intake was achieved: all participants achieved nutrient requirement within 3 days from the start of feeding Days between disease onset and initiation of feeding: 10 (4 to 23, NG tube); 11 (3 to 48, NJ tube) Type of feed used: semi‐elemental Method of insertion: bedside for NG feeding; endoscopic guidance for NJ feeding Confirmation of correct position: air test and aspiration of gastric content (NG tube); radiologically (NJ tube) Surgical treatment: NG feed (4), NJ feed (2) |
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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: India Funding: ICMR, New Delhi Conflicts of interest: None Retrospectively registered: CTRI/2009/091/000948 |
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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 done by a random number sequence generated by a statistician not associated with the conduct of the study. Block randomization with variable block size was used to generate random numbers" |
Allocation concealment (selection bias) | Low risk | Quote from report, "The method of allocation concealment was the sequentially numbered, sealed, opaque envelopes technique." |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | This was an open‐label study as blinding is impractical. There is no evidence of differences in the care and management of patients in the two groups. |
Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Quote from report, "It was not possible to blind the present study because of the nature of the treatment arms. A statistician (blinded to the route of feeding) performed the statistical analyses on the outcome measures" |
Blinding of outcome assessment (detection bias) Subjective outcomes (pain) | Low risk | This was an open‐label study, and the reporting of pain could potentially have been affected by knowledge of the intervention. However, in this study pain had to be accompanied by an increase in serum amylase to fulfil the study definition of pain exacerbation. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All randomised participants were included in the final analysis. |
Selective reporting (reporting bias) | Low risk | The trial was retrospectively registered at Clinical Trial Registry ‐ India. The prespecified outcomes in the methods were reported in the results. |
Other bias | Low risk | Authors received funding from ICMR, which was not associated with the conduct of the study or data analysis. The authors reported no conflict of interest. |
APACHE: acute physiology and chronic health evaluation BPM: beat per minute CRP: c reactive protein CT: computed tomography CTSI: computed tomography severity index ERCP: endoscopic retrograde cholangiopancreatography ES: endoscopic sphincterotomy HR: heart rate ICP: intracranial pressure ICU: intensive care unit IQR: interquartile range ITT: intention to treat MRCP: magnetic resonance cholangiopancreatography NG: nasogastric NJ: nasojejunal pCO2: partial pressure of carbon dioxide RR: respiratory rate SBP: systolic blood pressure VAS: visual analogue scale WBC: white blood cell