Open Surgery for Necrotizing Pancreatitis

Open Surgery for Necrotizing Pancreatitis in the Era of Minimally Invasive Approach: 10-year Experience in a High-volume Centre

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.

Study Overview

• Status: Completed
• Conditions: Pancreatitis,Acute Necrotizing
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 146

Contacts and Locations

Study Locations

• Russian Federation
  • Arkhangelsk Region
    • Arkhangel'sk, Arkhangelsk Region, Russian Federation, 163000
      • Northern State Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• N/A

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Northern State Medical University
• Investigators: Principal Investigator: Denis Mizgirev, DoctMedSci, Northern State Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2008
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): February 12, 2020

Study Registration Dates

• First Submitted: December 12, 2020
• First Submitted That Met QC Criteria: December 12, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: laparotomy; debridement; necrotizing pancreatitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Pancreatitis, Acute Necrotizing
• Other Study ID Numbers: denimsur1974

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No