Study Protocol for an Investigator Initiated, Observational Prospective Study, Evaluating the Rate of Postoperative Pancreatic Fistula in Distal Pancreatectomy Using AEON™ Endostapler

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

This prospective, observational study evaluates the rate of postoperative pancreatic fistula (POPF) following distal pancreatectomy (DP) using the AEON™ Endostapler. The study involves 110 patients undergoing DP and assesses primary outcomes based on the International Study Group of Pancreatic Fistula (ISGPF) classification, alongside secondary perioperative parameters. The findings aim to optimize surgical techniques, reduce complications, and improve healthcare outcomes.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Age 18 years or older.

• Ability to understand the nature and consequences of the study.

• Provision of written informed consent.

• Scheduled for minimally invasive or open distal pancreatectomy (DP) for any indication, with or without splenectomy and/or left adrenalectomy.

Locations
Other Locations
Germany
University Hospital Heidelberg
RECRUITING
Heidelberg
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2025-10-31
Participants
Target number of participants: 110
Sponsors
Leads: University Hospital Heidelberg

This content was sourced from clinicaltrials.gov