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

Phase 3

Completed

• Conditions: prophilatic drainage; 10014705

• Registration Number: NL-OMON55011
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-07-28
• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 169

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

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;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome is postoperative morbidity (Clavien-Dindo score >= 3). </p><br>

Secondary Outcome Measures

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