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First-day Versus Early Drain Removal Following PD: a Randomized Controlled Trial

NCT06468917 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2024-06-21

No results posted yet for this study

Summary

Pancreatic surgery is a complex discipline with a high risk of post-operative morbidity such as pancreatic fistula (POPF) with variable impact on clinical outcome. Controversies on ID placement have emerged from both randomized and non-randomized clinical studies investigating its possible role in increasing POPF and postoperative morbidity. The optimal timing for drain removal after PD is still a subject of debate: most studies have shown that outcomes are best when ID are removed in postoperative day (POD) 3 when POPF is excluded.

AIM we aim to compare postoperative surgical outcomes after PD in patients with low/medium risk for POPF (ISGPS risk class A-B-C), who undergo POD1 drains removal versus POD3 removal.

Primary aim: 1) grade B/C POPF; 2) post-pancreatectomy hemorrhage (PPH). Secondary aims: occurrence of fluid collection, sepsis, SSI, need for reintervention, length of stay, CD\>3, 90 days mortality, re-admission.

Study 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)

Conditions

  • Pancreas Fistula Abdominal Drains

Interventions

BEHAVIORAL

1st day removal of abdominal drain

once POPF is excluded in middle-low risk pancreatic resection, abdominal drains can be removed

Sponsors & Collaborators

  • University of Padova

    collaborator OTHER

  • Casa di Cura Dott. Pederzoli

    lead OTHER

Principal Investigators

  • isabella frigerio, MD · Casa di Cura Dott. Pederzoli

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2025-12-31
Completion
2026-03-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06468917 on ClinicalTrials.gov