Primary objectiveThe primary objective of this study is to assess the feasibility and safety of omitting prophylactic postoperative drainage after pancreatic surgery. This study was designed in order to gather conclusive information regarding the…
ID
Source
Brief title
Condition
- Exocrine pancreas conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Endpoints: The primary outcome of interest is the number of (re-)interventions,
specifically for pancreaticojenunostomy-, gastrojejunostomy- or
hepaticojejunostomy anastomosis leakage, abscess, intra-abdominal fluid
collections and postoperative haemorrhage, which are defined as drain related
complications. Re-interventions are defined as the administration of
antibiotics, endovascular coiling or stenting, ultrasound or CT guided drainage
or relaparotomy. Furthermore all complications will be monitored.
Secondary outcome
The secondary outcomes of interest are functional recovery and delay in
discharge, readmissions, mortality and total length of hospital stay.
Background summary
Prophylactic abdominal drainage after pancreaticoduodenectomy has been standard
of care for many years. However, recent studies assessing the efficacy of such
drains show these drains seem to have no advantage over avoiding prophylactic
postoperative drainage. In fact, some of these studies show that the use of
such drainage may even be harmful.
Study objective
Primary objective
The primary objective of this study is to assess the feasibility and safety of
omitting prophylactic postoperative drainage after pancreatic surgery. This
study was designed in order to gather conclusive information regarding the use
of postoperative prophylactic drainage after pancreaticoduodenectomy.
Secondary objective
Avoidance of drainage after surgery is an aspect of Enhanced Recovery After
Surgery pathways. If conclusive information should confirm the feasibility and
efficacy of omitting postoperative prophylactic drainage, implementation in the
ERAS-pathway for pancreatic surgery will follow to improve recovery.
Study design
The PANDA-Trial is a multicentre, randomized control trial with an experimental
design, conducted after elective pancreaticoduodenectomy. Prophylactic
postoperative drainage versus a no drain policy within an enhanced recovery
after surgery pathway will be assessed
Intervention
Intervention: Omitting prophylactic, postoperative, abdominal drainage
Comparison: Prophylactic postoperative drainage versus a no drain policy within
an Enhanced Recovery After Surgery pathway.
Study burden and risks
Discontinuing postoperative drainage was demonstrated not to result in higher
complication or mortality rates.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
- Diagnosis of pancreas head tumour
- Elective Pancreaticoduodenectomy
- Age > 18 years
- ASA I / II / III
- Written informed consent
Exclusion criteria
- Emergency surgery
- ASA IV / V
- Impossibility to obtain informed consent
- Pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL37950.068.11 |
| OMON | NL-OMON20546 |