NCT04673552

Brief Summary

Retrospective analysis of the cases of traditional open surgery for acute necrotizing pancreatitis, with evaluation of indications for surgery, intraoperative findings, mortality rate and risk factors of mortality.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
146

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

January 1, 2008

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

10 years

First QC Date

December 12, 2020

Last Update Submit

March 20, 2024

Conditions

Pancreatitis,Acute Necrotizing

Keywords

necrotizing pancreatitislaparotomydebridement

Outcome Measures

Primary Outcomes (2)

  • survival

    patient's discharge from the hospital

    01.001.2008 - 31.12.2017

  • death

    patient's death after the surgery

    01.001.2008 - 31.12.2017

Interventions

laparotomyPROCEDURE

Any open procedure such as laparotomy or lumbotomy for acute necrotizing pancreatitis will be evaluated, with assessment of results, complications and deaths

Also known as: lumbotomy, minimally invasive debridement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In-hospital patients of the First Emergency City Hospital named after E. E. Volosevich

You may qualify if:

  • laparotomy or lumbotomy performed for acute necrotizing pancreatitis from January, 2008 to December, 2017

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northern State Medical University

Arkhangelsk, Arkhangelskaya oblast, 163000, Russia

Location

MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing

Interventions

Laparotomy

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Denis Mizgirev, DoctMedSci

    Northern State Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2020

First Posted

December 17, 2020

Study Start

January 1, 2008

Primary Completion

December 31, 2017

Study Completion

February 12, 2020

Last Updated

March 21, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)