Umbilical HerniaNCT04088253
Umbilical Hernial Repair Using IPOM
A study testing umbilical herneal repair in people with Umbilical Hernia, run by Assiut University at 1 site in Egypt.
Trial summary
local repair of umbilical hernia in cirrhotic patient using intraperitoneal onlay mesh technique Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Umbilical Hernia
- What is being tested?
- umbilical herneal repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2019to 1 Sep 2022
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- informed consent patient age: ≥ 18 years elective surgery for umbilical hernia hernia diameter ≥ 1cm
Who cannot join
- previous history of median laparotomy navel site infection pregnancy incarcerated hernia recurrent hernia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Local Repair of Umbilical Hernia in Cirrhotic Patient Using Intraperitoneal Onlay Mesh Technique
local repair of umbilical hernia in cirrhotic patient using intraperitoneal onlay mesh technique
Read the detailed description
Umbilical hernia is common in cirrhotic patients suffering from ascites, with a prevalence up to 20%, which is 10 times higher than in the general population. Ascites is the major predisposing factor since it causes muscle wasting and increases intra-abdominal pressure. A unique feature of cirrhosis is low physiologic reserve, which increases the risk of death from complications of umbilical hernia and makes the patient more vulnerable to perioperative complications during repair. Because of the high operative risk, umbilical hernia repair has traditionally been reserved for the most complicated cases, such as strangulation of the bowel or rupture of the skin with leakage of ascitic fluid Many patients are thus managed conservatively, with watchful waiting. However, the natural course of umbilical hernia tends toward complications (eg, bowel incarceration, rupture of the overlying skin), which necessitate urgent repair. The risk of death with hernia repair in this urgent setting is seven times higher than for elective hernia repair in cirrhotic patients. More recent data indicate that elective repair in patients with well-compensated cirrhosis carries complication and mortality rates similar to those in noncirrhotic patients. Therefore, patients who should undergo umbilical hernia repair are not only those with complicated umbilical hernia (strangulation or ascites leak), but also those with well-compensated cirrhosis at risk of complications. Factors that pose a particularly high risk of complications of repair are large hernia (> 5 cm), hernia associated with pain, intermittent incarceration, and trophic alterations of the overlying skin. In these patients, elective repair should be considered if hepatic function is preserved, if ascites is well managed (sodium restriction, diuretics, and sometimes even preoperative transjugular intrahepatic portosystemic shunt placement), and if the patient is not expected to undergo liver transplantation in the near future. If liver transplantation is anticipated in the short term, umbilical hernia can be managed concomitantly. Management of ascites after umbilical hernia repair is essential for prevention of recurrence.
Aim of Work This study is aiming to assess the outcome of local repair of umbilical hernia in cirrhotic patient using intraperitoneal onlay mesh technique
Surgical Steps:
small skin incision over the hernia. Dissection and division the hernia sac
Reduction of the contents of the sac into the abdomen and excision of the redundant hernia sac.
Insertion of a finger or peanut sponge into the defect to clear the underside of the peritoneum of adhesions or bowel. Clear enough space around the defect to place a patch twice the size of the hernia defect.
Complete immersion of the mesh (in sterile saline for 1-3 seconds) immediately prior to placement in order to maximize the flexibility of the prosthesis.
Insertion of a small retractor into the defect to pull anterior and cephalad to make room for the mesh. Choose either the small, medium or large patch to insert into the defect. The chosen patch size should be approximately twice the size of the hernia defect. Gently fold or roll the patch parallel to the opening between the strap with the barrier side facing out carefully avoiding any sharp folding or kinking that might compromise the memory ring. Care should also be taken not to cut or nick the memory recoil ring. Gently insert the patch all the way through the defect and into the intraabdominal space, using an atraumatic clamp. Prevent the patch from touching the patients skin.
Remove the clamp and the small retractor. The memory recoil ring will allow the patch to "pop open." Gently pull up on the looped positioning strap until the patch rests against the abdominal wall without pulling harder than necessary. This allows the patch to evenly rest tension-free against the abdominal wall in all four quadrants.
While gently pulling up on the looped positioning strap, use a retractor to peer in between the anterior portion of the patch and the peritoneum to ensure that no tissue such as a bowel or omentum is caught between the patch and the abdominal wall Gently separate the two straps to allow access to the inner positioning pocket to ensure that the patch is lying flat in the intraabdominal space, against the anterior abdominal wall Utilizing the anterior mesh straps and pocket, place interrupted U-stitches in a minimum of two quadrants for the small patch (4.3 cm) and in four quadrants for the medium (6.4 cm) and large (8.0 cm) patches.
Care should be taken to ensure the sutures secure the fascia to the anterior polypropylene pocket only. For the appropriate amount of sutures follow your surgical judgement and adjust to specific patient needs.
Use nonabsorbable sutures to secure the patch by suturing the positioning straps to the margins of the defect. Cut off the excess positioning straps and discard. The patch recoil technology and abdominal pressure will ensure that the patch lies flat Reapproximate the fascia and then close the subcutaneous tissues. Lastly, reapproximate the wound
- Conditions
- Umbilical Hernia
- Being tested
- umbilical herneal repair
- Medical subject headings
- Hernia, Umbilical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
umbilical herneal repairProcedure or surgery
reduction of the herneal content an repair of the defect with IPOM
| Study group | Role | What they receive |
|---|---|---|
| cirrhotic patient | Experimental | cirrhotic patient with umbilical hernia to be operated Receives: Procedure: umbilical herneal repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
early wound complications
wound infection (with or without removal of the mesh) wound necrosis wound hematoma
Measured: 1 weak
late wound complications
wound infection (with or without removal of the mesh) wound necrosis wound hematoma
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start1 Oct 2019 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Umbilical HerniaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam mohamed, Assiut University
- Investigators
- Ahmed Soliman, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04088253
- Sponsor's protocol ID
- IPOM hernioplasty
- Status last verified
- Sep 2019
- First submitted
- 11 Sep 2019
- Last updated
- 13 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: age, sex , clinical diagnosis
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Repair of Umbilical Hernia in Cirrhotic Patient Using Intraperitoneal Onlay Mesh Technique
- ClinicalTrials.gov ID
- NCT04088253
- Acronym / sponsor ID
- IPOM hernioplasty
- Conditions
- Umbilical Hernia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 12 Sep 2019 (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.
local repair of umbilical hernia in cirrhotic patient using intraperitoneal onlay mesh technique
Detailed description
Umbilical hernia is common in cirrhotic patients suffering from ascites, with a prevalence up to 20%, which is 10 times higher than in the general population. Ascites is the major predisposing factor since it causes muscle wasting and increases intra-abdominal pressure. A unique feature of cirrhosis is low physiologic reserve, which increases the risk of death from complications of umbilical hernia and makes the patient more vulnerable to perioperative complications during repair. Because of the high operative risk, umbilical hernia repair has traditionally been reserved for the most complicated cases, such as strangulation of the bowel or rupture of the skin with leakage of ascitic fluid Many patients are thus managed conservatively, with watchful waiting. However, the natural course of umbilical hernia tends toward complications (eg, bowel incarceration, rupture of the overlying skin), which necessitate urgent repair. The risk of death with hernia repair in this urgent setting is seven times higher than for elective hernia repair in cirrhotic patients. More recent data indicate that elective repair in patients with well-compensated cirrhosis carries complication and mortality rates similar to those in noncirrhotic patients. Therefore, patients who should undergo umbilical hernia repair are not only those with complicated umbilical hernia (strangulation or ascites leak), but also those with well-compensated cirrhosis at risk of complications. Factors that pose a particularly high risk of complications of repair are large hernia (> 5 cm), hernia associated with pain, intermittent incarceration, and trophic alterations of the overlying skin. In these patients, elective repair should be considered if hepatic function is preserved, if ascites is well managed (sodium restriction, diuretics, and sometimes even preoperative transjugular intrahepatic portosystemic shunt placement), and if the patient is not expected to undergo liver transplantation in the near future. If liver transplantation is anticipated in the short term, umbilical hernia can be managed concomitantly. Management of ascites after umbilical hernia repair is essential for prevention of recurrence.
Aim of Work This study is aiming to assess the outcome of local repair of umbilical hernia in cirrhotic patient using intraperitoneal onlay mesh technique
Surgical Steps:
small skin incision over the hernia. Dissection and division the hernia sac
Reduction of the contents of the sac into the abdomen and excision of the redundant hernia sac.
Insertion of a finger or peanut sponge into the defect to clear the underside of the peritoneum of adhesions or bowel. Clear enough space around the defect to place a patch twice the size of the hernia defect.
Complete immersion of the mesh (in sterile saline for 1-3 seconds) immediately prior to placement in order to maximize the flexibility of the prosthesis.
Insertion of a small retractor into the defect to pull anterior and cephalad to make room for the mesh. Choose either the small, medium or large patch to insert into the defect. The chosen patch size should be approximately twice the size of the hernia defect. Gently fold or roll the patch parallel to the opening between the strap with the barrier side facing out carefully avoiding any sharp folding or kinking that might compromise the memory ring. Care should also be taken not to cut or nick the memory recoil ring. Gently insert the patch all the way through the defect and into the intraabdominal space, using an atraumatic clamp. Prevent the patch from touching the patients skin.
Remove the clamp and the small retractor. The memory recoil ring will allow the patch to "pop open." Gently pull up on the looped positioning strap until the patch rests against the abdominal wall without pulling harder than necessary. This allows the patch to evenly rest tension-free against the abdominal wall in all four quadrants.
While gently pulling up on the looped positioning strap, use a retractor to peer in between the anterior portion of the patch and the peritoneum to ensure that no tissue such as a bowel or omentum is caught between the patch and the abdominal wall Gently separate the two straps to allow access to the inner positioning pocket to ensure that the patch is lying flat in the intraabdominal space, against the anterior abdominal wall Utilizing the anterior mesh straps and pocket, place interrupted U-stitches in a minimum of two quadrants for the small patch (4.3 cm) and in four quadrants for the medium (6.4 cm) and large (8.0 cm) patches.
Care should be taken to ensure the sutures secure the fascia to the anterior polypropylene pocket only. For the appropriate amount of sutures follow your surgical judgement and adjust to specific patient needs.
Use nonabsorbable sutures to secure the patch by suturing the positioning straps to the margins of the defect. Cut off the excess positioning straps and discard. The patch recoil technology and abdominal pressure will ensure that the patch lies flat Reapproximate the fascia and then close the subcutaneous tissues. Lastly, reapproximate the wound
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cirrhotic patient | Experimental | Procedure: umbilical herneal repaircirrhotic patient with umbilical hernia to be operated |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- informed consent patient age: ≥ 18 years elective surgery for umbilical hernia hernia diameter ≥ 1cm
Key exclusion criteria (1 listed)
- previous history of median laparotomy navel site infection pregnancy incarcerated hernia recurrent hernia
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 |
|---|---|---|
| umbilical herneal repairreduction of the herneal content an repair of the defect with IPOM | Procedure or surgery | cirrhotic patient |
Primary outcome
early wound complications
Time frame: 1 weak
wound infection (with or without removal of the mesh) wound necrosis wound hematoma
late wound complications
Time frame: 1 month
wound infection (with or without removal of the mesh) wound necrosis wound hematoma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
- Individual participant dataSharing planned: Yes. age, sex , clinical diagnosis
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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.
Ahmed Soliman study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing umbilical herneal repair in people with Umbilical Hernia, run by Assiut University at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 13 Sep 2019. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hossam zaher (+201069369274, hossamzaher3@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early wound complications (time frame: 1 weak). 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 13 Sep 2019.