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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

Tracking Information
First Submitted Date December 12, 2020
First Posted Date December 17, 2020
Last Update Posted Date March 21, 2024
Actual Study Start Date January 1, 2008
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 23, 2020)
  • survival [ Time Frame: 01.001.2008 - 31.12.2017 ]
    patient's discharge from the hospital
  • death [ Time Frame: 01.001.2008 - 31.12.2017 ]
    patient's death after the surgery
Original Primary Outcome Measures
 (submitted: December 12, 2020)
  • survival [ Time Frame: 01.001.2008 - 31.12.2017 ]
    patient was discharged from the hospital
  • death [ Time Frame: 01.001.2008 - 31.12.2017 ]
    patient died after the surgery
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Open Surgery for Necrotizing Pancreatitis
Official Title Open Surgery for Necrotizing Pancreatitis in the Era of Minimally Invasive Approach: 10-year Experience in a High-volume Centre
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population In-hospital patients of the First Emergency City Hospital named after E. E. Volosevich
Condition Pancreatitis,Acute Necrotizing
Intervention 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
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 12, 2020)		 146
Original Actual Enrollment Same as current
Actual Study Completion Date February 12, 2020
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number NCT04673552
Other Study ID Numbers denimsur1974
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Northern State Medical University
Original Responsible Party Same as current
Current Study Sponsor Northern State Medical University
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Denis Mizgirev, DoctMedSci Northern State Medical University
PRS Account Northern State Medical University
Verification Date March 2024