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NCT05711433 Clinical Trial

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

Pancreas Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05711433
Other study ID # zagazig 16
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2014
Est. completion date September 1, 2022

Study information
Verified date February 2023
Source Zagazig University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 347
Est. completion date September 1, 2022
Est. primary completion date July 1, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• pancreatic surgery
pancreaticoduodenectomy and distal pancreatectomy

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Zagazig University

Outcome
Type Measure Description Time frame Safety issue
Primary incidence of postoperative pancreatic fistula 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
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