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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55011

Enrollment

140

Registered

2020-09-25

Start date

2020-10-05

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prophilatic drainage

Interventions

Distal pancreatectomy without prophylactic abdominal drainage via a percutaneous drain.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: At least 18 years old; Elective indication for DP, with or without splenectomy, minimally invasive or open, for all indications Fit to undergo surgery; Oral and written informed consent;

Exclusion criteria

Exclusion criteria: o Pregnancy; o DP as a secondary procedure during gastric or colonic resection; o Colonic resection required for cancer extension (gastric resection allowed) o Participation to another study with interference with study outcome;

Design outcomes

Primary

Measure	Time frame
Primary outcome is postoperative morbidity (Clavien-Dindo score >= 3).	—

Secondary

Measure	Time frame
The most relevant secondary outcome is grade B/C POPF. Other secondary outcomes include surgical reintervention, percutaneous catheter drainage, endoscopic catheter drainage, abdominal collections (not requiring drainage), wound infection, delayed gastric emptying, post-pancreatectomy hemorrhage as defined by the international study group for pancreatic surgery (ISGPS)6, length of stay (LOS), readmission within 30 days, in-hospital mortality, 30-day mortality and 90-day mortality.	—

Measure

Time frame

The most relevant secondary outcome is grade B/C POPF. Other secondary outcomes include surgical reintervention, percutaneous catheter drainage, endoscopic catheter drainage, abdominal collections (not requiring drainage), wound infection, delayed gastric emptying, post-pancreatectomy hemorrhage as defined by the international study group for pancreatic surgery (ISGPS)6, length of stay (LOS), readmission within 30 days, in-hospital mortality, 30-day mortality and 90-day mortality.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)