Status:
NOT_YET_RECRUITING
Prophylactic Abdominal Drainage vs no Drainage After Distal Pancreatectomy
Lead Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra
Conditions:
Postoperative Pancreatic Fistula
Distal Pancreatectomy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Postoperative pancreatic fistula (POPF) is a major source of morbidity and mortality after pancreatic resection, especially after distal pancreatectomy (PD). Today, POPF remains one of the main causes...
Detailed Description
A prospective, randomised, multicentre, multicentre, randomised non-inferiority study is designed. The aim is to study whether patients who undergo distal pancreatectomy can benefit from the non-place...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Adult patients (over 18 years of age) undergoing elective distal pancreatectomy surgery for any indication, with or without splenectomy, minimally invasive or open. It is not necessary to integrate gender perspective as it is not relevant and there is no influence on the results of POPF or morbidity.
- Signed informed consent was obtained from each of the patients included in the study.
- Exclusion criteria
- Patients undergoing distal pancreatectomy as a secondary procedure
- Additional liver, gastric or colonic resection
- Pregnancy
- Participation in another study
- History of previous surgery involving the pancreas
- Patients with American Society of Anaesthesiologists classification 4
- Arterial resection other than the splenic artery
Exclusion
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT06141044
Start Date
January 1 2024
End Date
December 1 2027
Last Update
November 21 2023
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