Ventral Hernias in Cirrhotic PatientsNCT04726644
Evaluation of Surgical Techniques in Cirrhotic Patients With Ventral Hernias
An observational study of Ventral Hernias in Cirrhotic Patients, run by Assiut University.
Trial summary
ventral hernias are defects of the anterior abdominal wall, which can be congenital or acquired including epigastric, umbilical and incisional hernia. Umbilical hernias represent a common surgical problem in cirrhotic patient with ascites with 20% incidence. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ventral Hernias in Cirrhotic Patients
- What is being tested?
- hernia repair
- Type of treatment
- Surgery or procedure
- How many people
- 148 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 12 Dec 2018
- How long will I take part?
- 2 Years
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: all patients with liver cirrhosis present with ventral hernias
Who may be able to join
- all cirrhotic patients with ventral hernia
Who cannot join
- hepatic encephalopathy
About this study
Official title: Ventral Hernias in Cirrhotic Patients
ventral hernias are defects of the anterior abdominal wall, which can be congenital or acquired including epigastric, umbilical and incisional hernia. Umbilical hernias represent a common surgical problem in cirrhotic patient with ascites with 20% incidence. This work was deigned to assess outcome of different techniques of closure of ventral hernias in cirrhotic patients.
Read the detailed description
Ventral hernias are defects of the anterior abdominal wall, which can be congenital or acquired including epigastric, umbilical and incisional hernia. Incisional ventral hernia is a frequent complication of laparotomy that occurs in up to 11 % of surgical abdominal wounds
Umbilical hernia represent a common surgical problem in cirrhotic patient with ascites with 20% incidence.Factors that play role in occurance of umbilical hernia in cirrhotic patient with ascites patients is chronic increased intra-abdominal pressure, recanalization of the left umbilical vein, muscle wasting and fascial weakening from nutritional deficiencies (3,4).
Most of interventions for umbilical herniorrhaphy in cirrhotic patients with ascites done in emergency setting due to the concept of high perioperative morbidity and mortality rates in those patients. However, this strategy leads to a high risk of life-threatening complications such as incarceration and skin rupture.
- Conditions
- Ventral Hernias in Cirrhotic Patients
- Being tested
- hernia repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hernia repairProcedure or surgery
different methods for hernia repair
| Study group | Role | What they receive |
|---|---|---|
| patients | cirrhotic patients with ventral hernia Receives: Procedure: hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
ventral hernia repair
different technique for repair of ventral hernia
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start1 Jan 2017
- Primary completion12 Dec 2018
- Study completion12 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral Hernias in Cirrhotic PatientsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 148 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohammed Abu Elfatth, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726644
- Sponsor's protocol ID
- El-rajhi Liver Hospital
- Status last verified
- Jan 2021
- First submitted
- 23 Jan 2021
- Last updated
- 27 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventral Hernias in Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT04726644
- Acronym / sponsor ID
- El-rajhi Liver Hospital
- Conditions
- Ventral Hernias in Cirrhotic Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 12 Dec 2018 (actual)
- First posted
- 27 Jan 2021 (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.
ventral hernias are defects of the anterior abdominal wall, which can be congenital or acquired including epigastric, umbilical and incisional hernia. Umbilical hernias represent a common surgical problem in cirrhotic patient with ascites with 20% incidence. This work was deigned to assess outcome of different techniques of closure of ventral hernias in cirrhotic patients.
Detailed description
Ventral hernias are defects of the anterior abdominal wall, which can be congenital or acquired including epigastric, umbilical and incisional hernia. Incisional ventral hernia is a frequent complication of laparotomy that occurs in up to 11 % of surgical abdominal wounds
Umbilical hernia represent a common surgical problem in cirrhotic patient with ascites with 20% incidence.Factors that play role in occurance of umbilical hernia in cirrhotic patient with ascites patients is chronic increased intra-abdominal pressure, recanalization of the left umbilical vein, muscle wasting and fascial weakening from nutritional deficiencies (3,4).
Most of interventions for umbilical herniorrhaphy in cirrhotic patients with ascites done in emergency setting due to the concept of high perioperative morbidity and mortality rates in those patients. However, this strategy leads to a high risk of life-threatening complications such as incarceration and skin rupture.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | – | Procedure: hernia repaircirrhotic patients with ventral hernia |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- all patients with liver cirrhosis present with ventral hernias
Key inclusion criteria (1 listed)
- all cirrhotic patients with ventral hernia
Key exclusion criteria (1 listed)
- hepatic encephalopathy
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 |
|---|---|---|
| hernia repairdifferent methods for hernia repair | Procedure or surgery | patients |
Primary outcome
ventral hernia repair
Time frame: Baseline
different technique for repair of ventral hernia
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 27 Jan 2021.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventral Hernias in Cirrhotic Patients, run by Assiut University.
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 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
ventral hernia repair (time frame: Baseline). 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 27 Jan 2021.