A prospective randomised clinical trial for closure of the pancreatic remnant following distal pancreatectomy

ISRCTN	ISRCTN78326544
DOI	https://doi.org/10.1186/ISRCTN78326544
Protocol serial number	7/2001
Sponsor	Petz Aladar Teaching Hospital (Hungary)
Funder	Petz Aladar Teaching Hospital (Hungary)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof Attila Olah
Scientific

Petz Aladar Teaching Hospital
Vasvari P. u. 2.
Gyor
9024
Hungary

Primary study design	Interventional
Study design	Prospective randomised single-centre clinical trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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.
Ethics approval(s)	Regional Committee of Science and Research Ethics. Date of approval: 20/11/2001 (ref: 76-1-73/A/09)
Health condition(s) or problem(s) studied	Pancreatic fistula and/or intra-abdominal fluid collection
Intervention	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.
Intervention type	Other
Primary outcome measure(s)	The rate of post-operative pancreatic fistula and intra-abdominal fluid collection. The 3-month post-operative period was analysed.
Key secondary outcome measure(s)	1. The rate of re-interventions, either surgical or radiological 2. Length of hospital stay The 3-month post-operative period was analysed.
Completion date	31/12/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	70
Key inclusion criteria	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
Key exclusion criteria	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
Date of first enrolment	01/01/2002
Date of final enrolment	31/12/2006

Petz Aladar Teaching Hospital

Gyor
9024
Hungary

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan