- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04430816
Management Of Large Incisional Hernia, Double Mesh Modification Of Chevrel's Technique Versus On Lay Mesh Hernioplasty
Management Of Large Incisional Hernia, Double Mesh Modification Of Chevrel's Technique Versus On Lay Mesh Hernioplasty, A Comparative Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sharqya
-
Zagazig, Sharqya, Egypt, 44519
- Zagazig Faculty of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
• above 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: modified chevrel technique
22 participant with large midline incisional hernia underwent repair by double mesh modification of chevrel's technique
|
repair of midline incisional hernia by double mesh modification of chevrel's technique
|
Active Comparator: ON LAY mesh hernioplasty
21 participant with large midline incisional hernia underwent repair by online mesh hernioplasty
|
repair of midline incisional hernia by online mesh hernioplasty
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
24 hours postoperative
|
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
|
24 hours after drain removal
|
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
|
in the first 2 years post operative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
difference between operative time of both groups
Time Frame: 1 day
|
the time between the start point of the operative procedure and the end of the operative procedure
|
1 day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- compared chevrel hazem
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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