NCT05711433

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
347

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 3, 2023

Completed
Last Updated

February 3, 2023

Status Verified

February 1, 2023

Enrollment Period

5 years

First QC Date

October 21, 2022

Last Update Submit

February 2, 2023

Conditions

Pancreas Neoplasm

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

pancreatic surgeryPROCEDURE

pancreaticoduodenectomy and distal pancreatectomy

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • \<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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
42 Months
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professour of general and laparoscopic surgery

Study Record Dates

First Submitted

October 21, 2022

First Posted

February 3, 2023

Study Start

July 1, 2014

Primary Completion

July 1, 2019

Study Completion

September 1, 2022

Last Updated

February 3, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share