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

February 2, 2023 updated by: Tamer.A.A.M.Habeeb, Zagazig University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

347

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A retrospective observational study was conducted in the surgical unit of Zagazig university hospital from July 2014 to July 2019. 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2014

Primary Completion (ACTUAL)

July 1, 2019

Study Completion (ACTUAL)

September 1, 2022

Study Registration Dates

First Submitted

October 21, 2022

First Submitted That Met QC Criteria

February 2, 2023

First Posted (ACTUAL)

February 3, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 3, 2023

Last Update Submitted That Met QC Criteria

February 2, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • zagazig 16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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