Prophylactic Abdominal Drainage vs no Drainage After Distal Pancreatectomy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinica Universidad de Navarra, Universidad de Navarra

About this trial

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 of hospital length of stay and healthcare costs. Numerous surgical techniques have been tested to reduce its incidence without success, so the current standard for the management of POPF, and the avoidance of associated complications, is intraoperative drain placement. However, surgically placed drains are not without risk. In recent years many studies, mostly retrospective, have attempted to determine whether omission of prophylactic drainage is associated with increased morbidity. These studies suggest that patients may benefit from not having a drain placed. This evidence challenges standard practice and the debate of whether or not to place a drain after distal pancreatectomy remains open. The investigators designed a prospective multicentre randomised non-inferiority study to determine whether prophylactic intraoperative drainage is associated with a lower morbidity rate after distal pancreatectomy.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Patients undergoing distal pancreatectomy as a secondary procedure

Additional liver, gastric or colonic resection

Pregnancy

Participation in another study

Trial design

Treatments tested in this trial

  • Avoid surgical drainage

Treatment groups

104 Participants
are divided into 2 treatment groups

Locations

This trial has no locations