Condition category
Digestive System
Date applied
09/07/2008
Date assigned
21/07/2008
Last edited
21/07/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Attila Olah

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7/2001

Study information

Scientific title

Acronym

Study hypothesis

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

Regional Committee of Science and Research Ethics. Date of approval: 20/11/2001 (ref: 76-1-73/A/09)

Study design

Prospective randomised single-centre clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

The rate of post-operative pancreatic fistula and intra-abdominal fluid collection. The 3-month post-operative period was analysed.

Secondary outcome measures

1. The rate of re-interventions, either surgical or radiological
2. Length of hospital stay

The 3-month post-operative period was analysed.

Overall trial start date

01/01/2002

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

70 patients

Participant 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

Recruitment start date

01/01/2002

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Hungary

Trial participating centre

Petz Aladar Teaching Hospital
Gyor
9024
Hungary

Sponsor information

Organisation

Petz Aladar Teaching Hospital (Hungary)

Sponsor details

PO Box 92
Gyor
9024
Hungary

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Petz Aladar Teaching Hospital (Hungary)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes