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Open Surgery for Necrotizing Pancreatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04673552
Recruitment Status : Completed
First Posted : December 17, 2020
Last Update Posted : March 21, 2024
Sponsor:
Information provided by (Responsible Party):
Northern State Medical University

Study Description
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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.

Condition or disease Intervention/treatment
Pancreatitis,Acute Necrotizing Procedure: laparotomy

Detailed Description:
All cases of laparotomy/lumbotomy will be retrospectively analysed, with evaluation of mortality, complications, in-hospital stay, indications for surgery, findings during operation, combination with minimally invasive procedures (radiological drainage, necrosectomy). Assessment of risk factors, like erosive bleeding, intraperitoneal perforation of collection, gut resection, splenectomy, relaparotomy will be done.
Study Design
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Study Type : Observational
Actual Enrollment : 146 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Open Surgery for Necrotizing Pancreatitis in the Era of Minimally Invasive Approach: 10-year Experience in a High-volume Centre
Actual Study Start Date : January 1, 2008
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : February 12, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Groups and Cohorts
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Intervention Details:
  • Procedure: laparotomy
    Any open procedure such as laparotomy or lumbotomy for acute necrotizing pancreatitis will be evaluated, with assessment of results, complications and deaths
    Other Names:
    • lumbotomy
    • minimally invasive debridement

Outcome Measures
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Primary Outcome Measures :
  1. survival [ Time Frame: 01.001.2008 - 31.12.2017 ]
    patient's discharge from the hospital

  2. death [ Time Frame: 01.001.2008 - 31.12.2017 ]
    patient's death after the surgery


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
In-hospital patients of the First Emergency City Hospital named after E. E. Volosevich
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04673552


Locations
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Russian Federation
Northern State Medical University
Arkhangel'sk, Arkhangelsk Region, Russian Federation, 163000
Sponsors and Collaborators
Northern State Medical University
Investigators
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Principal Investigator: Denis Mizgirev, DoctMedSci Northern State Medical University
More Information
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Responsible Party: Northern State Medical University
ClinicalTrials.gov Identifier: NCT04673552    
Other Study ID Numbers: denimsur1974
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: March 21, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Northern State Medical University:
necrotizing pancreatitis
laparotomy
debridement
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Acute Necrotizing
Pancreatic Diseases
Digestive System Diseases