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.
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.
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
- Conditions
- Hernia Incisional Ventral
- 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 group | Role | What they receive |
|---|---|---|
| modified chevrel technique | Active comparator | 22 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 hernioplasty | Active comparator | 21 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.
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
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
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)
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.
- First posted12 Jun 2020
- Study start1 Jan 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia Incisional VentralStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- 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)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hazem Nour Abdellatif, Zagazig University
- Investigators
- hazem nour, MD, Principal investigator, zag university
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management Of Large Incisional Hernia, Double Mesh Modification Of Chevrel's Technique Versus On Lay Mesh Hernioplasty, A Comparative Study
- ClinicalTrials.gov ID
- NCT04430816
- Acronym / sponsor ID
- compared chevrel hazem
- Conditions
- Hernia Incisional Ventral
- Keywords
- midline incisional hernia chevrel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 12 Jun 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.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| modified chevrel technique | Active comparator | Procedure: double mesh modification of chevrel's technique22 participant with large midline incisional hernia underwent repair by double mesh modification of chevrel's technique |
| ON LAY mesh hernioplasty | Active comparator | Procedure: on lay mesh hernioplasty21 participant with large midline incisional hernia underwent repair by online mesh hernioplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- above 18 years old suffering large midline incisional hernia.
Key exclusion criteria (4 listed)
- complicated incisional hernia,
- advanced cardiac, respiratory, liver and renal diseases
- patients with abdominal and abdominal wall malignancy
- ASA III and IV
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 |
|---|---|---|
| double mesh modification of chevrel's techniquerepair of midline incisional hernia by double mesh modification of chevrel's technique | Procedure or surgery | modified chevrel technique |
| on lay mesh hernioplastyrepair of midline incisional hernia by online mesh hernioplasty | Procedure or surgery | ON LAY mesh hernioplasty |
Primary outcome
incidence of skin flap ischemia
Time frame: 24 hours postoperative
impaired capillary filling of wound skin flaps , measured by clinical examination (capillary filling time > 2 seconds)
incidence of seroma formation
Time frame: 24 hours after drain removal
presence of more than 20 ml serous fluid collected around the mesh prosthesis measured by superficial probe ultrasound
incidence of hernia recurrence
Time frame: in the first 2 years post operative
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
1 secondary outcome
difference between operative time of both groups
Time frame: 1 day
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 12 Jun 2020.
- Individual participant dataSharing planned: No
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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.
hazem nour, MD principal investigator
zag 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 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.