- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04562363
Prevention of Postoperative Ventral Hernias
February 11, 2022 updated by: Ryazan State Medical University
Prevention of Postoperative Ventral Hernias After Median Laparotomy in Urgent Surgery
The research is aimed at identifying factors of herniation after median laparotomy and developing surgical methods for preventing postoperative ventral hernias and eventrations.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
At the first stage, an analysis of the prevalence of postoperative ventral hernias in patients after median laparotomies in urgent surgery will be performed, with the identification of factors contributing to the development of postoperative ventral hernias.
At the next stage, the investigators will search for the most reliable methods of suturing the white line of the abdomen, taking into account the risk of hernia formation, with their implementation in patients operated in an emergency through median laparotomic access in comparison with traditionally used methods.
In conclusion, an algorithm will be developed for selecting the method of surgical prevention of postoperative ventral hernias, taking into account the risk of their development.
Study Type
Observational
Enrollment (Actual)
700
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Ryazan, Russian Federation
- RyazSMU
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Ryazan Region
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Ryazan, Ryazan Region, Russian Federation, 390026
- RyazSMU
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The prospective study included 700 patients, including those operated through a midline laparotomic approach to identify factors of herniation, and those who are planned to have a midline laparotomy in order to choose a rational method of suturing a laparotomic wound, taking into account the risk of incisional hernia formation.
Taking into account the degree of risk of postoperative ventral hernia development and the choice of the method of its prevention, the patients were divided into 4 groups.
Description
Inclusion Criteria:
- Patients of both sexes aged 18 years and older who are expected to perform median laparotomy on a planned or emergency basis.
- Patients who have signed an informed consent to participate in the study, after the purpose and meaning of the study have been explained to them.
- Patients who follow the doctor's instructions.
Exclusion Criteria:
- The death of the patient.
- Stage IV cancer
- Hernia repair with hernioplasty, including simultaneous surgery
- Refusal of the patient to cooperate with the researcher.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Low risk of herniation.
Use of any method of suturing, including modified.
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Suturing the white line of the abdomen with the help of developed techniques aimed at preventing hernias and eventrations
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The average risk of hernia formation
The application of modified methods of closure of laparotomy wound.
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Suturing the white line of the abdomen with the help of developed techniques aimed at preventing hernias and eventrations
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high risk of herniation
The use of alloplastic methods of closure of laparotomy wound.
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Suturing the white line of the abdomen with the help of developed techniques aimed at preventing hernias and eventrations
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The presence of eventrations
The use of alloplastic methods of suturing a laparotomic wound in the absence of suppuration.
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Suturing the white line of the abdomen with the help of developed techniques aimed at preventing hernias and eventrations
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wound complications
Time Frame: 2 weeks
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Frequency of wound complications in the early postoperative period.
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2 weeks
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Eventration
Time Frame: 2 weeks
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Frequency of events in the early postoperative period
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2 weeks
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Pain syndrome
Time Frame: 2 year
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The severity of pain syndrome in the postoperative scar after midline laparotomy using a verbal scale of pain syndrome
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2 year
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Postoperative ventral hernia
Time Frame: 2 year
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Frequency of postoperative ventral hernia in the late postoperative period
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2 year
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Defects in the aponeurosis
Time Frame: 2 year
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Frequency of aponeurosis defects in the late postoperative period
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2 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alexander Inyutin, PhD MD, RyazSMU
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 12, 2018
Primary Completion (Actual)
December 12, 2021
Study Completion (Actual)
December 12, 2021
Study Registration Dates
First Submitted
August 28, 2020
First Submitted That Met QC Criteria
September 18, 2020
First Posted (Actual)
September 24, 2020
Study Record Updates
Last Update Posted (Actual)
February 14, 2022
Last Update Submitted That Met QC Criteria
February 11, 2022
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- POVG12122021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Undecided Basic demographic data, including sex, age, and ethnicity are to be shared if allowed by the privacy policy.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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