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ISRCTN
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ISRCTN78326544
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ClinicalTrials.gov identifier
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Public title
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A prospective randomised clinical trial for closure of the pancreatic remnant following distal pancreatectomy
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Scientific title
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Acronym
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N/A
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Serial number at source
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7/2001
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Study hypothesis
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Pancreatic fistula and intra-abdominal fluid collection are the most common complications of distal pancreatectomy. Our aim is to compare post-operative complication rates of the techniques of the closure of the pancreatic stump such as the simple stapling or the combined method of covering the stapled stump with a seromuscular patch of the jejunum.
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Ethics approval
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Regional Committee of Science and Research Ethics. Date of approval: 20/11/2001 (ref: 76-1-73/A/09)
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Study design
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Prospective randomised single-centre clinical trial
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Countries of recruitment
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Hungary
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Disease/condition/study domain
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Pancreatic fistula and/or intra-abdominal fluid collection
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Participants - inclusion criteria
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1. Aged 18 to 80 years, either sex
2. Distal pancreatectomy is indicated because of a benign or malignant tumour of the pancreas, chronic pancreatitis or malignant neoplasm of other organs infiltrating the pancreas, provided the parenchyma of the pancreas is suitable for stapling
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Participants - exclusion criteria
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1. Aged under the age of 18 or over the age of 80 years
2. Too thick or wide parenchyma of the pancreas
3. Death in the first 72 hours of the post-operative period
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Anticipated start date
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01/01/2002
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Anticipated end date
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31/12/2006
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Status of trial
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Completed
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Patient information material
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Target number of participants
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70 patients
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Interventions
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Distal pancreatectomy was performed in both groups. In the control group the pancreatic stump was closed by a stapler. In the intervention group the pancreatic remnant was first closed by a stapler then covered by a seromuscular patch of the jejunum.
The total duration of follow-up was 3 months in both groups.
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Primary outcome measure(s)
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The rate of post-operative pancreatic fistula and intra-abdominal fluid collection. The 3-month post-operative period was analysed.
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Secondary outcome measure(s)
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1. The rate of re-interventions, either surgical or radiological
2. Length of hospital stay
The 3-month post-operative period was analysed.
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Sources of funding
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Petz Aladar Teaching Hospital (Hungary)
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Trial website
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Publications
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Contact name
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Prof
Attila
Olah
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Address
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Petz Aladar Teaching Hospital
Vasvari P. u. 2.
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City/town
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Gyor
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Zip/Postcode
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9024
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Country
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Hungary
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Sponsor
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Petz Aladar Teaching Hospital (Hungary)
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Address
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PO Box 92
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City/town
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Gyor
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Zip/Postcode
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9024
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Country
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Hungary
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Date applied
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09/07/2008
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Last edited
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21/07/2008
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Date ISRCTN assigned
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21/07/2008
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