Pancreatitis,Acute NecrotizingNCT04673552
Open Surgery for Necrotizing Pancreatitis
An observational study of Pancreatitis,Acute Necrotizing, run by Northern State Medical University at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis,Acute Necrotizing
- What is being tested?
- laparotomy
- Type of treatment
- Surgery or procedure
- How many people
- 146 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jan 2008to 12 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In-hospital patients of the First Emergency City Hospital named after E. E. Volosevich
Who may be able to join
- laparotomy or lumbotomy performed for acute necrotizing pancreatitis from January, 2008 to December, 2017
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
Russia1 site
Northern State Medical University
Arkhangelsk, Arkhangelskaya oblast, 163000
About this study
Official title: 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.
Read the 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.
- Conditions
- Pancreatitis,Acute Necrotizing
- Being tested
- laparotomy
- Keywords
- necrotizing pancreatitis, laparotomy, debridement
- Medical subject headings
- Pancreatitis, Acute Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparotomyProcedure or surgery
Also called lumbotomy, minimally invasive debridement
Any open procedure such as laparotomy or lumbotomy for acute necrotizing pancreatitis will be evaluated, with assessment of results, complications and deaths
What is being measured
The primary outcome is the main question the study is designed to answer.
survival
patient's discharge from the hospital
Measured: 01.001.2008 - 31.12.2017
death
patient's death after the surgery
Measured: 01.001.2008 - 31.12.2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start1 Jan 2008
- Primary completion31 Dec 2017
- Study completion12 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatitis,Acute NecrotizingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denis Mizgirev, DoctMedSci, Principal investigator, Northern State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673552
- Sponsor's protocol ID
- denimsur1974
- Status last verified
- Mar 2024
- First submitted
- 12 Dec 2020
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Surgery for Necrotizing Pancreatitis in the Era of Minimally Invasive Approach: 10-year Experience in a High-volume Centre
- ClinicalTrials.gov ID
- NCT04673552
- Acronym / sponsor ID
- denimsur1974
- Conditions
- Pancreatitis,Acute Necrotizing
- Keywords
- necrotizing pancreatitis, laparotomy, debridement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Northern State Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 12 Feb 2020 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In-hospital patients of the First Emergency City Hospital named after E. E. Volosevich
Key inclusion criteria (1 listed)
- laparotomy or lumbotomy performed for acute necrotizing pancreatitis from January, 2008 to December, 2017
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparotomyAlso: lumbotomy, minimally invasive debridementAny open procedure such as laparotomy or lumbotomy for acute necrotizing pancreatitis will be evaluated, with assessment of results, complications and deaths | Procedure or surgery | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis Mizgirev, DoctMedSci principal investigator
Northern State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatitis,Acute Necrotizing, run by Northern State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival (time frame: 01.001.2008 - 31.12.2017). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.