AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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.

Egypt1 site, 1 recruiting
  • Assiut university

    Asyut

    Recruiting

Other trials in Egypt

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

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 groups in NCT04088253
Study groupRoleWhat they receive
cirrhotic patientExperimentalcirrhotic 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.

  1. early wound complications

    wound infection (with or without removal of the mesh) wound necrosis wound hematoma

    Measured: 1 weak

  2. 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.

  1. First posted12 Sep 2019
  2. Study start1 Oct 2019 (estimated)
  3. Primary completion1 Mar 2022 (estimated)
  4. Study completion1 Sep 2022 (estimated)

Resources

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)
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

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.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in