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
• Status: Completed
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Fistula
• Pancreas Neoplasm
• Pancreatic Fistula
• Pancreatic Neoplasms

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