First-day Versus Early Drain Removal Following Pancreaticoduodenectomy: a Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Design: This is a randomized, controlled, open-label study. All patients will be randomized on POD1, using computer-generated randomization codes. Group A: Drain removal on POD 1 (in case of POD 1 DFA\< 300 U/L) Group B: Drain removal on POD 3 (in case of POD 1 DFA\< 300 U/L)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• Patients (age ≥ 18 or \< 85 years) undergoing elective pancreaticoduodenectomy providing informed consent.
• Intraoperative low to moderate risk for POPF (ISGPS class A-B-C)
• POD 1 DFA \< 300U/L
Locations
Other Locations
Italy
Cdcpederzoli
RECRUITING
Peschiera Del Garda
Contact Information
Primary
isabella frigerio, MD
isabella.frigerio@ospedalepederzoli.it
00390456449187
Backup
giovanni butturini, MD
butturinichirurgo@gmail.com
00390456449283
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2026-03-30
Participants
Target number of participants: 224
Treatments
Active_comparator: Drain removal on POD 1
in case of POD 1 DFA\< 300 U/L
Active_comparator: Drain removal on POD 3
in case of POD 1 DFA\< 300 U/L
Related Therapeutic Areas
Sponsors
Collaborators: University of Padova
Leads: Casa di Cura Dott. Pederzoli