Condition category
Injury, Occupational Diseases, Poisoning
Date applied
27/06/2007
Date assigned
06/07/2007
Last edited
06/05/2008
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 Helmut Witzigmann

ORCID ID

Contact details

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

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

http://www.khdf.de

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

Publication citations

Additional files

Editorial Notes