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Hernia Incisional VentralNCT04430816

Management Of Large Incisional Hernia, Double Mesh Modification Of Chevrel's Technique Versus On Lay Mesh Hernioplasty

A study testing double mesh modification of chevrel's technique and on lay mesh hernioplasty in people with Hernia Incisional Ventral, run by Zagazig University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

comparison between two groups of large midline incisional hernia, the first group managed by double mesh modification of chevrel's technique the second one managed by conventional onlay mesh repair Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hernia Incisional Ventral
What is being tested?
double mesh modification of chevrel's technique and on lay mesh hernioplasty
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteEgypt
Study dates
1 Jan 2017to 31 Dec 2019
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • above 18 years old suffering large midline incisional hernia.

Who cannot join

  • complicated incisional hernia,
  • advanced cardiac, respiratory, liver and renal diseases
  • patients with abdominal and abdominal wall malignancy
  • ASA III and IV

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Zagazig Faculty of Medicine

    Zagazig, Sharqya, 44519

Other trials in Egypt

About this study

Official title: Management Of Large Incisional Hernia, Double Mesh Modification Of Chevrel's Technique Versus On Lay Mesh Hernioplasty, A Comparative Study

comparison between two groups of large midline incisional hernia, the first group managed by double mesh modification of chevrel's technique the second one managed by conventional onlay mesh repair

Read the detailed description

This comparative study was carried out in general surgery unit, Zagazig university hospitals, between January 2018 and December 2020, on 43 cases with large incisional hernia, participants were randomly allocated according to the deemed option of management into two groups, group A, the modified Chevrel group, 22 participants were treated by double mesh modification of Chevrel's technique, and group B, the on-lay group, participants treated by anatomical repair and fixation of non-absorbable mesh in on-lay position.

inclusion criteria

  • > 18 years old suffering large midline incisional hernia. exclusion criteria
  • complicated incisional hernia,
  • advanced cardiac, respiratory, liver and renal diseases
  • patients with abdominal and abdominal wall malignancy
  • ASA III and IV The study condition is the large midline incisional hernia defined as hernia following mid line incision, its defect is 10 cm or more in any of its diameters.

The main outcome of the study is recurrence of hernia and local complications mainly skin sloughing, seroma formation and wound infection.

All the study participants signed an informed written consent, the study was approved by our local ethical committee and institutional review board All the study participants were subjected to thorough history taking and full systemic and abdominal examination chest X ray, abdomino-pelvic ultrasound examination, measuring of the defect by ultrasound or abdominal CT if needed, preoperative routine laboratory tests, fractionated heparin was given when indicated as a prophylaxis for deep venous thrombosis (BMI >35, previous history of DVT,), they were given third generation cephalosporins just before the induction of anesthesia.

Procedures :

In participants of the double mesh modification of Chevrel's technique, after excision of the previous scar, skin and subcutaneous tissue was dissected off the hernia sac, the sac was then opened, released off intra-abdominal adhesions and resected, the real defect size was measured, the skin and subcutaneous tissue was dissected off the anterior rectus sheath, dissection was limited to less than 2 cm lateral to the hernia defect edges.

Then, a bilateral vertical incisions of the anterior rectus sheath was done parallel to the midline and at maximum 2 cm far from it thus two medial anterior rectus sheath flaps could be created and dissected off the rectus abdominis muscles on both sides, dissection of both recti abdominis muscles was continued to be separated off the posterior rectus sheath opening the retro-rectus space, linea alba was reformed by suturing each of the newly formed medial anterior rectus sheath flaps to its fellow of the other side, using Vicryl\0 sutures, the flaps help tension free closure of the defect and formation of a common posterior rectus sheath,

A prolene mesh was spread in the retro-rectus space, extending between the two lateral ends of the space and 4 cm beyond the vertical edges of the defect, fixed to the posterior sheath with prolene sutures .

At the end the anterior rectus sheath was closed with prolene mesh tailored to the space between lateral flaps of anterior rectus sheath, and sutured to their medial edges with interrupted non absorbable sutures .

In the group of on-lay mesh repair the old scar was excised, the sac was laid open at its fundus, adhesolysis was done to free the abdominal viscera from the parietal peritoneum, the sac was excised, skin and subcutaneous tissue were dissected of the anterior rectus sheath till the linea semilunaris, taking care to preserve the perforating vessels, anatomical repair was done by midline closure with prolene 1\0 non absorbable interrupted suture, a prolene mesh was fixed in on-lay position by prolene 2\0 sutures.

In both groups after proper hemostasis a suction drain was left over the mesh, subcutaneous tissue was approximated by vicryl 3\0 skin closed by prolene 3\0.in the postoperative period patients received non-steroid pain killer according to need and third generation cephalosporin intravenous injection, wounds were observed after 24 hours for assessment of any local wound complications specially skin flap ischemia, after discharge patients were followed up in the outpatients clinic by the attending surgeon, follow up data including (wound complications as sloughing of skin flap, drainage amount and duration, corset feeling, parasthesia of abdominal wall and corset feeling) was collected in each visit, two months after operation an abdominal wall ultrasound examination was done for detection of early recurrence, a clinic visits or phone contact was done every 6 months till the end of the study.

Continues data was presented in mean and standard deviation, statistically analyzed using t test, z test, in SPSS program 22

Being tested
double mesh modification of chevrel's technique, on lay mesh hernioplasty
Keywords
midline incisional hernia chevrel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • double mesh modification of chevrel's techniqueProcedure or surgery

    repair of midline incisional hernia by double mesh modification of chevrel's technique

  • on lay mesh hernioplastyProcedure or surgery

    repair of midline incisional hernia by online mesh hernioplasty

Study groups in NCT04430816
Study groupRoleWhat they receive
modified chevrel techniqueActive comparator22 participant with large midline incisional hernia underwent repair by double mesh modification of chevrel's technique
Receives: Procedure: double mesh modification of chevrel's technique
ON LAY mesh hernioplastyActive comparator21 participant with large midline incisional hernia underwent repair by online mesh hernioplasty
Receives: Procedure: on lay mesh hernioplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. incidence of skin flap ischemia

    impaired capillary filling of wound skin flaps , measured by clinical examination (capillary filling time > 2 seconds)

    Measured: 24 hours postoperative

  2. incidence of seroma formation

    presence of more than 20 ml serous fluid collected around the mesh prosthesis measured by superficial probe ultrasound

    Measured: 24 hours after drain removal

  3. incidence of hernia recurrence

    presence of hernia defect of any size in the midline or near it detected by ultrasound or coputerized tomography scan of the anterior abdominal wall

    Measured: in the first 2 years post operative

Secondary outcomes (1)
  1. difference between operative time of both groups

    the time between the start point of the operative procedure and the end of the operative procedure

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2020
  2. Study start1 Jan 2017
  3. Primary completion31 Dec 2019
  4. Study completion31 Dec 2019

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
Randomised
Intervention model
Parallel groups
Model description
two groups of patients with incisional hernia group A underwent double mesh modification of chevrel's technique, group B underwent onlay mesh hernioplasty
Masking
Single blind
Who is masked
Participant
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04430816
Sponsor's protocol ID
compared chevrel hazem
Status last verified
Jun 2020
First submitted
7 Jun 2020
Last updated
12 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing double mesh modification of chevrel's technique and on lay mesh hernioplasty in people with Hernia Incisional Ventral, run by Zagazig 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 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 12 Jun 2020. 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?

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?

incidence of skin flap ischemia (time frame: 24 hours postoperative). The study lists 3 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 12 Jun 2020.

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