The study compares regular use of surgical drains and no use of surgical drains in patients subjected to pancreaticoduodenectomy with expected low to intermediate risk for post operative pancreatic fistula.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Linkoping University Hospital
Linköping, Sweden
RECRUITINGSkanes University Hospital
Lund, Sweden
RECRUITINGOverall morbidity rate
Post operative morbidity
Time frame: 90 days post operatively
Mortality rate (in-hospital, 30 and 90 days)
Time frame: 90 days post operatively
Severe morbidity rate as classified by Clavien-Dindo >3
Time frame: 90 days post operatively
Fistula rate according to ISGPF
Time frame: 90 days post operatively
Intraabdominal abscess rate
Time frame: 90 days post operatively
Wound infection rate
Time frame: 90 days post operatively
Delayed gastric emptying according to ISGPF
Time frame: 90 days post operatively
Postpancreatectomy bleeding according to ISGPF
Time frame: 90 days post operatively
Need of interventional radiology
Time frame: 90 days post operatively
Need for reoperation
Time frame: 90 days post operatively
Hospital stay
Time frame: 90 days post operatively
Readmission rate
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Time frame: 90 days post operatively