Gangrenous Postoperative Ventral Hernia (Diagnosis)NCT04562363
Prevention of Postoperative Ventral Hernias
An observational study of Gangrenous Postoperative Ventral Hernia (Diagnosis) and Dehiscence of Laparotomy Wound, run by Ryazan State Medical University at 2 sites in Russia.
Trial summary
The research is aimed at identifying factors of herniation after median laparotomy and developing surgical methods for preventing postoperative ventral hernias and eventrations. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Gangrenous Postoperative Ventral Hernia (Diagnosis), Dehiscence of Laparotomy Wound
- What is being tested?
- Suturing of a laparotomic wound with modified methods
- Type of treatment
- Surgery or procedure
- How many people
- 700 participants
- Where
- 2 sitesRussia
- Study dates
- 12 Dec 2018to 12 Dec 2021
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- The death of the patient.
- Stage IV cancer
- Hernia repair with hernioplasty, including simultaneous surgery
- Refusal of the patient to cooperate with the researcher.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Suturing of a laparotomic wound with modified methods
- Keywords
- Postoperative ventral hernia, eventrat, defects of the fascia, laparotomic wound suture, preventive prosthetics of a laparotomic wound
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suturing of a laparotomic wound with modified methodsProcedure or surgery
Suturing the white line of the abdomen with the help of developed techniques aimed at preventing hernias and eventrations
| Study group | Role | What they receive |
|---|---|---|
| Low risk of herniation. | Use of any method of suturing, including modified. Receives: Procedure: Suturing of a laparotomic wound with modified methods | |
| The average risk of hernia formation | The application of modified methods of closure of laparotomy wound. Receives: Procedure: Suturing of a laparotomic wound with modified methods | |
| high risk of herniation | The use of alloplastic methods of closure of laparotomy wound. Receives: Procedure: Suturing of a laparotomic wound with modified methods | |
| The presence of eventrations | The use of alloplastic methods of suturing a laparotomic wound in the absence of suppuration. Receives: Procedure: Suturing of a laparotomic wound with modified methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound complications
Frequency of wound complications in the early postoperative period.
Measured: 2 weeks
Eventration
Frequency of events in the early postoperative period
Measured: 2 weeks
Pain syndrome
The severity of pain syndrome in the postoperative scar after midline laparotomy using a verbal scale of pain syndrome
Measured: 2 year
Postoperative ventral hernia
Frequency of postoperative ventral hernia in the late postoperative period
Measured: 2 year
Defects in the aponeurosis
Frequency of aponeurosis defects in the late postoperative period
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start12 Dec 2018
- Primary completion12 Dec 2021
- Study completion12 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gangrenous Postoperative Ventral Hernia (Diagnosis)Studies 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
- Prospective
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ryazan State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Inyutin, PhD MD, Principal investigator, RyazSMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562363
- Sponsor's protocol ID
- POVG12122021
- Status last verified
- Oct 2021
- First submitted
- 28 Aug 2020
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Undecided Basic demographic data, including sex, age, and ethnicity are to be shared if allowed by the privacy policy.
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Postoperative Ventral Hernias After Median Laparotomy in Urgent Surgery
- ClinicalTrials.gov ID
- NCT04562363
- Acronym / sponsor ID
- POVG12122021
- Keywords
- Postoperative ventral hernia, eventrat, defects of the fascia, laparotomic wound suture, preventive prosthetics of a laparotomic wound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Ryazan State Medical UniversityUniversity, hospital or other
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 12 Dec 2021 (actual)
- Study completion
- 12 Dec 2021 (actual)
- First posted
- 24 Sep 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.
The research is aimed at identifying factors of herniation after median laparotomy and developing surgical methods for preventing postoperative ventral hernias and eventrations.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low risk of herniation. | – | Procedure: Suturing of a laparotomic wound with modified methodsUse of any method of suturing, including modified. |
| The average risk of hernia formation | – | Procedure: Suturing of a laparotomic wound with modified methodsThe application of modified methods of closure of laparotomy wound. |
| high risk of herniation | – | Procedure: Suturing of a laparotomic wound with modified methodsThe use of alloplastic methods of closure of laparotomy wound. |
| The presence of eventrations | – | Procedure: Suturing of a laparotomic wound with modified methodsThe use of alloplastic methods of suturing a laparotomic wound in the absence of suppuration. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- The death of the patient.
- Stage IV cancer
- Hernia repair with hernioplasty, including simultaneous surgery
- Refusal of the patient to cooperate with the researcher.
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 |
|---|---|---|
| Suturing of a laparotomic wound with modified methodsSuturing the white line of the abdomen with the help of developed techniques aimed at preventing hernias and eventrations | Procedure or surgery | Low risk of herniation., The average risk of hernia formation, The presence of eventrations, high risk of herniation |
Primary outcome
Wound complications
Time frame: 2 weeks
Frequency of wound complications in the early postoperative period.
Eventration
Time frame: 2 weeks
Frequency of events in the early postoperative period
Pain syndrome
Time frame: 2 year
The severity of pain syndrome in the postoperative scar after midline laparotomy using a verbal scale of pain syndrome
Postoperative ventral hernia
Time frame: 2 year
Frequency of postoperative ventral hernia in the late postoperative period
Defects in the aponeurosis
Time frame: 2 year
Frequency of aponeurosis defects in the late postoperative period
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 14 Feb 2022.
- Individual participant dataSharing planned: No. Undecided Basic demographic data, including sex, age, and ethnicity are to be shared if allowed by the privacy policy.
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.
Alexander Inyutin, PhD MD principal investigator
RyazSMU
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gangrenous Postoperative Ventral Hernia (Diagnosis) and Dehiscence of Laparotomy Wound, run by Ryazan State Medical University at 2 sites 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 3 inclusion and 4 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 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Wound complications (time frame: 2 weeks). The study lists 5 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 14 Feb 2022.