PANDA-trial.

A multicentre, randomized control trial after pancreaticoduodenectomy, within an enhanced recovery after surgery pathway. Prophylactic postoperative drainage versus a no drain policy.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20546

Enrollment

360

Registered

2012-01-04

Start date

2012-03-01

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

pancreas, pancreaticoduodenectomy, postoperative recovery, complications

Interventions

Control group (group A): Conventional prophylactic drainage applied adhering to routine protocols, drain removal on POD 4

Study group (group B): No prophylactic drainage after surgery.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnosis of pancreas head tumour; 2. Elective Pancreaticoduodenectomy; 3. Age > 18 years; 4. ASA I / II / III; 5. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Emergency surgery; 2. ASA IV / V; 3. Impossibility to obtain informed consent; 4. Pregnancy.

Design outcomes

Primary

Measure	Time frame
1. Need for radiological or surgical drainage; 2. Overall complications.	—

Secondary

Measure	Time frame
1. Postoperative lenght of hospital stay; 2. Functional recovery; 3. Mortality; 4. Readmission.	—

Contacts

Public ContactR.M. Dam, van

Department of Surgery Maastricht University Medical Centre P.O. Box 5800

r.van.dam@mumc.nl+31 (0)43 3876543

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)