Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
EK-BR-23/07-1
Study information
Scientific title
Acronym
PANDRA
Study hypothesis
The hypothesis of the present study is that a short-time (two days) abdominal drainage does not decrease the rate of re-interventions after pancreas resection. Therefore it is not necessary to place an intra-abdominal drainage.
Ethics approval
Ethics approval received from the Sächsische Landesärztekammer Ethics Committee on the 20th June 2007 (ref: EK-BR-23/07-1).
Study design
Prospective, pre-operatively randomised controlled trial performed as a parallel group design.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Pancreas resection
Intervention
Each participant will be randomised to one of the following two groups:
Intervention group: intra-abdominal drainage for two days following pancreas resection
Control group: no drainage following pancreas resection
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The rate of re-interventions (operative and interventional) after pancreas resection.
Secondary outcome measures
The following will be monitored for 14 days after operation:
1. Surgical overall morbidity
2. Pancreatic fistula
3. Intra-abdominal abscess
4. Mortality
Overall trial start date
01/07/2007
Overall trial end date
31/12/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age equal or above 18 years
2. Patients with resectable malignancies of the pancreas
3. Patients with benign tumours of the pancreas
4. Patients with chronic pancreatitis
5. Patients with other rare indications for pancreatic resection (i.e., bleeding)
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
188 participants each group
Participant exclusion criteria
1. Patients with a cardiac infarction within six months before operation
2. Chemotherapy within eight weeks before operation
3. Malignancy that has not responded to treatment within five years before operation
4. Lack of compliance
5. Pregnancy
6. Participation in another trial with interference of intervention or outcome
Recruitment start date
01/07/2007
Recruitment end date
31/12/2010
Locations
Countries of recruitment
Germany
Trial participating centre
Hospital of Dresden-Friedrichstadt
Dresden
01067
Germany
Sponsor information
Organisation
Hospital of Dresden-Friedrichstadt (Germany)
Sponsor details
Department of General and Visceral Surgery
Friedrichstrasse 41
Dresden
01067
Germany
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Hospital of Dresden-Friedrichstadt (Germany)
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