Incisional Hernia of Midline of Upper AbdomenNCT04166201
Double Mesh Modification of Incisional Hernia Can be Effective Without Severe Local Complications
A study testing double mesh hernioplasty with modified chevrel's technique in people with Incisional Hernia of Midline of Upper Abdomen and Incisional Hernia of Midline of Lower Abdomen, run by Zagazig University at 1 site in Egypt.
Trial summary
22 patients of incisional hernia underwent treatment by double mesh modification of the original Chevrel's technique the primary outcome was recurrence, skin necrosis secondery out come was pain hematoma seroma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia of Midline of Upper Abdomen, Incisional Hernia of Midline of Lower Abdomen, Incisional Hernia of Midline of Abdomen
- What is being tested?
- double mesh hernioplasty with modified chevrel's technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2017to 30 Dec 2018
- 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
- adult with midline incisional hernia
Who cannot join
- (ASA) 3, and 4,
- inflammatory bowel disease,
- urgent setting,
- recurrences and previous abdominal neoplasms with high risk of local recurrence (rectal cancer).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Double Mesh Modification of Chevrel's Technique in Management of Midline Incisional Hernia
22 patients of incisional hernia underwent treatment by double mesh modification of the original Chevrel's technique the primary outcome was recurrence, skin necrosis secondery out come was pain hematoma seroma
Read the detailed description
This study is a clinical trial carried out on 22 patients with midline incisional hernia, using the double mesh modification of Chevrel's technique, all the procedures were performed by the same group of surgeons.
The exclusion criteria were American Society of Anesthesiologists (ASA) 3, and 4, inflammatory bowel disease, urgent setting, recurrences and previous abdominal neoplasms with high risk of local recurrence (rectal cancer). All patients were informed and consented before recruitment in the study All patients received an intravenous antibiotic prophylaxis with subcutaneous administration of fractionated heparin before surgery when indicated.
Surgical technique All patients were operated on with the double mesh modification of Chevrel's technique. The previous scar was excised then, dissection of the subcutaneous space was performed deep to the neck of the hernia, not wider than 1cm from the edges of the defect, then the sac was opened and resected, the defect size was measured, the skin and subcutaneous tissue was dissected off the anterior rectus sheath only allowing dissection of an anterior rectus sheath flap just sufficient to close the defect without tension After that a bilateral longitudinal incisions was done on the anterior surface of the anterior rectus sheath and a medial anterior rectus sheath flap was dissected off the rectus abdominis muscle, both recti muscles was dissected off the posterior rectus sheath opening the retrorectus space, each of the medial anterior rectus sheath flaps was sutured to that of the other side with slowly absorbed sutures closing the defect without any tension and reforming the posterior rectus sheath
A sizable prolene mesh was fixed with prolene sutures in the retrorectus space spreading between lateral ends of the space and tunneled up 4 cm in the retrorectus space far from vertical edges of the defect,Then the anterior rectus sheath was closed using a prolene mesh tailored to the size of the space between the lateral flaps of both sides and sutured to the edges of the lateral flaps with interrupted non absorbable sutures.
suction drain is left in site, subcutaneous tissue was closed with Vicryl (3\0) , skin was closed with prolene (3\0), drain was removed when the amount of drainage is below 30 ml \ day .
Data of the patients as demographic data, preoperative investigations, operative findings as defect size, operative time, early postoperative data as viability of skin flaps, wound infection, seroma and early hernia recurrence, late postoperative data as hernia recurrence. All data were collected, properly presented and analyzed using the SPSS package 22.
- Conditions
- Incisional Hernia of Midline of Upper Abdomen, Incisional Hernia of Midline of Lower Abdomen, Incisional Hernia of Midline of Abdomen
- Being tested
- double mesh hernioplasty with modified chevrel's technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
double mesh hernioplasty with modified chevrel's techniqueProcedure or surgery
hernioplasty done by modification of the chevrel's technique , no dissection further than 1 cm of the midline laterally, the medial flaps of the anterior rectus sheath is dissected of the anterior surface of the rectus abdominis muscle and sutured together reforming the posterior rectus sheath , one polypropylene mesh was fixed over the posterior rectus sheath and the other was tailored to raw area of the rectis abdominis muscle and sutured to the lateral free edges of the anterior rectus sheath
| Study group | Role | What they receive |
|---|---|---|
| modified chevrel technique | Other | hernioplasty done with double mesh modification of chevrels technique Receives: Procedure: double mesh hernioplasty with modified chevrel's technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence of the hernia
the incisional hernia recurs back measured by clinical examination or abdominal CT
Measured: 2 years
necrosis of the edges of the wound
gangrene of the medial edges of the midline incision after dissection of the skin and subcutaneous tissue off the rectus sheath measured by clinical examination
Measured: 1 week
Secondary outcomes (3)
seroma
presence of serous fluid collection in the subcutaneous space measured by superficial probe ultrasound examination
Measured: 1 week
hematoma
blood collection around the mesh prosthesis measured by superficial probe ultrasound examination
Measured: 1 week
abdominal wall pain
pain related to the surgical wound or the mesh prosthesis fixation sutures , measured by visual analogue scale
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start1 Jan 2017
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional Hernia of Midline of Upper AbdomenStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- 22 patients with Incisional Hernia of Midline of the abdomen underwent hernioplasty by double mesh modification of Chevrel's technique follow up carried out for around 2 years for hernia recurrence pain early and late postoperative complications
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hazem Nour Abdellatif, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166201
- Sponsor's protocol ID
- modified chevrel technique
- Status last verified
- Nov 2019
- First submitted
- 14 Nov 2019
- Last updated
- 22 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Double Mesh Modification of Chevrel's Technique in Management of Midline Incisional Hernia
- ClinicalTrials.gov ID
- NCT04166201
- Acronym / sponsor ID
- modified chevrel technique
- Conditions
- Incisional Hernia of Midline of Upper Abdomen, Incisional Hernia of Midline of Lower Abdomen, Incisional Hernia of Midline of Abdomen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 18 Nov 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.
22 patients of incisional hernia underwent treatment by double mesh modification of the original Chevrel's technique the primary outcome was recurrence, skin necrosis secondery out come was pain hematoma seroma
Detailed description
This study is a clinical trial carried out on 22 patients with midline incisional hernia, using the double mesh modification of Chevrel's technique, all the procedures were performed by the same group of surgeons.
The exclusion criteria were American Society of Anesthesiologists (ASA) 3, and 4, inflammatory bowel disease, urgent setting, recurrences and previous abdominal neoplasms with high risk of local recurrence (rectal cancer). All patients were informed and consented before recruitment in the study All patients received an intravenous antibiotic prophylaxis with subcutaneous administration of fractionated heparin before surgery when indicated.
Surgical technique All patients were operated on with the double mesh modification of Chevrel's technique. The previous scar was excised then, dissection of the subcutaneous space was performed deep to the neck of the hernia, not wider than 1cm from the edges of the defect, then the sac was opened and resected, the defect size was measured, the skin and subcutaneous tissue was dissected off the anterior rectus sheath only allowing dissection of an anterior rectus sheath flap just sufficient to close the defect without tension After that a bilateral longitudinal incisions was done on the anterior surface of the anterior rectus sheath and a medial anterior rectus sheath flap was dissected off the rectus abdominis muscle, both recti muscles was dissected off the posterior rectus sheath opening the retrorectus space, each of the medial anterior rectus sheath flaps was sutured to that of the other side with slowly absorbed sutures closing the defect without any tension and reforming the posterior rectus sheath
A sizable prolene mesh was fixed with prolene sutures in the retrorectus space spreading between lateral ends of the space and tunneled up 4 cm in the retrorectus space far from vertical edges of the defect,Then the anterior rectus sheath was closed using a prolene mesh tailored to the size of the space between the lateral flaps of both sides and sutured to the edges of the lateral flaps with interrupted non absorbable sutures.
suction drain is left in site, subcutaneous tissue was closed with Vicryl (3\0) , skin was closed with prolene (3\0), drain was removed when the amount of drainage is below 30 ml \ day .
Data of the patients as demographic data, preoperative investigations, operative findings as defect size, operative time, early postoperative data as viability of skin flaps, wound infection, seroma and early hernia recurrence, late postoperative data as hernia recurrence. All data were collected, properly presented and analyzed using the SPSS package 22.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 22 patients with Incisional Hernia of Midline of the abdomen underwent hernioplasty by double mesh modification of Chevrel's technique follow up carried out for around 2 years for hernia recurrence pain early and late postoperative complications
| Arm | Type | Receives |
|---|---|---|
| modified chevrel technique | Other | Procedure: double mesh hernioplasty with modified chevrel's techniquehernioplasty done with double mesh modification of chevrels technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult with midline incisional hernia
Key exclusion criteria (4 listed)
- (ASA) 3, and 4,
- inflammatory bowel disease,
- urgent setting,
- recurrences and previous abdominal neoplasms with high risk of local recurrence (rectal cancer).
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 hernioplasty with modified chevrel's techniquehernioplasty done by modification of the chevrel's technique , no dissection further than 1 cm of the midline laterally, the medial flaps of the anterior rectus sheath is dissected of the anterior surface of the rectus abdominis muscle and sutured together reforming the posterior rectus sheath , one polypropylene mesh was fixed over the posterior rectus sheath and the other was tailored to raw area of the rectis abdominis muscle and sutured to the lateral free edges of the anterior rectus sheath | Procedure or surgery | modified chevrel technique |
Primary outcome
recurrence of the hernia
Time frame: 2 years
the incisional hernia recurs back measured by clinical examination or abdominal CT
necrosis of the edges of the wound
Time frame: 1 week
gangrene of the medial edges of the midline incision after dissection of the skin and subcutaneous tissue off the rectus sheath measured by clinical examination
3 secondary outcomes
seroma
Time frame: 1 week
hematoma
Time frame: 1 week
abdominal wall pain
Time frame: 1 year
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 22 Nov 2019.
- Individual participant dataSharing planned: Undecided
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.
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 hernioplasty with modified chevrel's technique in people with Incisional Hernia of Midline of Upper Abdomen and Incisional Hernia of Midline of Lower Abdomen, 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 22 Nov 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?
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?
recurrence of the hernia (time frame: 2 years). 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 22 Nov 2019; AzTrials last refreshed its copy on 3 Nov 2026.