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OpenTrials
Completed

NCT Number: NCT05711433

Risk Factors for Postoperative Pancreatic Fistula Following Non-traumatic Pancreatic Surgery. Retrospective Observational Study.

Postoperative pancreatic fistula is a potentially fatal sequela with substantial morbidity and mortality. A retrospective observational study was conducted in the surgical unit of Zagazig university hospital . Three hundred forty-seven patients were admitted with a clinical diagnosis of pancreatic fistula following both open and laparoscopic approaches for pancreatic benign and malignant tumors.

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Key information

About this study

Postoperative pancreatic fistula is a potentially fatal sequela with substantial morbidity and mortality. POPF incidence and risk factors vary.

A retrospective observational study was conducted in the surgical unit of Zagazig university hospital . Three hundred forty-seven patients were admitted with a clinical diagnosis of pancreatic fistula following both open and laparoscopic approaches for pancreatic benign and malignant tumors.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • > 18 years,
  • both sexes,
  • respectablee pancreaticoduodenal tumors, or chronic pancreatitis

Exclusion criteria

  • <18 years,
  • Patients who underwent total pancreatectomies,
  • Patients discovered intraoperatively to be fixed to portal vein or superior mesenteric artery, traumatic pancreatic surgeries, postoperative associated gastric or biliary leak, pancreaticoduodenal cancers infiltrating the colon, stomach or liver.

Treatment and study plan

Pancreatic surgery

Procedure

pancreaticoduodenectomy and distal pancreatectomy

Primary outcomes

  1. incidence of postoperative pancreatic fistula

    Time frame: 3.5 years

    an amylase level in the fluid collected from the drain on the third postoperative day (POD) that was > three times the serum amylase level

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2022
First posted
Feb 3, 2023
Registry last updated
Feb 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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