Intra-abdominal drainage for two days versus no DRAinage following PANcreas resection

ISRCTN	ISRCTN04937707
DOI	https://doi.org/10.1186/ISRCTN04937707
Secondary identifying numbers	EK-BR-23/07-1

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Helmut Witzigmann
Scientific

Hospital of Dresden-Friedrichstadt
Department of General and Visceral Surgery
Friedrichstrasse 41
Dresden
01067
Germany

Study design	Prospective, pre-operatively randomised controlled trial performed as a parallel group design.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Intra-abdominal drainage for two days versus no DRAinage following PANcreas resection
Study acronym	PANDRA
Study objectives	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(s)	Ethics approval received from the Sächsische Landesärztekammer Ethics Committee on the 20th June 2007 (ref: EK-BR-23/07-1).
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/07/2007
Completion date	31/12/2010

Participant type(s)	Patient
Age group	Not Specified
Lower age limit	18 Years
Sex	Both
Target number of participants	188 participants each group
Total final enrolment	438
Key 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)
Key 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
Date of first enrolment	01/07/2007
Date of final enrolment	31/12/2010

Hospital of Dresden-Friedrichstadt

Dresden
01067
Germany

Hospital of Dresden-Friedrichstadt (Germany)
Hospital/treatment centre

Department of General and Visceral Surgery
Friedrichstrasse 41
Dresden
01067
Germany

Website	http://www.khdf.de
"ROR"	https://ror.org/035xba693

Hospital/treatment centre

Hospital of Dresden-Friedrichstadt (Germany)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2016	31/12/2020	Yes	No

31/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.