Prophylactic abdominal drainage or no drainage after distal pancreatectomy: a binational multicenter randomized controlled trial

Prophylactic abdominal drainage is current standard practice after distal
pancreatectomy (DP), with the aim to divert pancreatic juice in case of a
postoperative pancreatic fistula (POPF) aimed to prevent further complications.
Whereas POPF after pancreatoduodenectomy, by definition, involves infection due
to anastomotic dehiscence, a POPF after DP is essentially sterile since the
bowel is not opened and no anastomoses are created. Routine drainage could
therefore be omitted after DP and this could even be beneficial because of the
hypothetical prevention of drain-induced infections.5 Abdominal drainage (i.e.
the act of placing a surgical drain), moreover, should only be done if it
provides additional safety or comfort to the patient. In clinical practice,
drains cause clear discomfort amongst patients in the postoperative phase so
the omitting of a drain would benefit them. The only currently available
multicenter randomized controlled trial confirmed the safety of omitting
abdominal drainage but did not stratify patients according to their risk of
POPF and did not describe a standardized strategy for pancreatic transection.
This is relevant since it might influence the outcome of omitting abdominal
drainage. Therefore, a large pragmatic multicenter randomized controlled trial
is required, stratifying patients for their baseline risk of POPF.

To evaluate the non-inferiority of omitting routine intra-abdominal drainage
after distal pancreatectomy on postoperative morbidity (Clavien-Dindo score >=
3), and, secondarily, POPF grade B/C.

Binational multicenter randomized controlled trial, stratifying patients to
high and low risk for POPF grade B/C and incorporating a standardized strategy
for pancreatic transection.

Distal pancreatectomy without prophylactic abdominal drainage via a
percutaneous drain.

The only other randomized controlled trial showed leaving out the drain can be
done without an increase of postoperative comnplications. This trial involves a
standerdized transsection techique and will be stratified bases on risk factors
of developing a POPF. This way we hope the differentiate between different
groups of patients so we can see which ones won't need a drain anymore.
Patients will benefit from this study in the way that they will not receive a
drain, so they won't have the pain and/or discomfort of the drain. They will be
closely monitored in the ward, as always, and when there is a clinical
indication the will receive a scan to check for fluid collections that need to
be drained.