Incisional Hernia Repair by Abdominal Wall Component Release With Contemporary Onlay Mesh Fixation
1 other identifier
interventional
17
1 country
1
Brief Summary
There is a great expansion in the presentation of complex incisional hernia defects. Primary closure for most cases is impossible with a high rate of recurrence. Component separation provides an autologous repair of the defect but still has considerable recurrence rate. Reinforcement of component separation provides a more strength full repair and may be less recurrence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedFirst Submitted
Initial submission to the registry
December 16, 2023
CompletedFirst Posted
Study publicly available on registry
December 21, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedDecember 21, 2023
December 1, 2023
1 year
December 16, 2023
December 16, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
detect black color at the incision site
the detection by vision
postoperative day 1 and 2
Secondary Outcomes (1)
detect pulge at incision site
from postoperative day 1 to 6 months postoperative
Study Arms (1)
Abdominal Wall Component Release with Contemporary Onlay Mesh Fixation
OTHERAbdominal Wall Component Release with Contemporary Onlay Mesh Fixation in patients with incisional hernia
Interventions
patients with incisional hernia will be operated by hernia reduction and sac closure followed by placement of onlay mesh after creating suitable flaps.
Eligibility Criteria
You may qualify if:
- Age of 16 years and older.
- Both sexes.
- Patients with clean incisional hernia of stage I, II and III according to the ventral hernia staging system were included.
You may not qualify if:
- \- Obese patients with BMI ≥35 kg/m2, Patients with contaminated hernia stage II and III, patients with collagen disease, patients with history of aortobifemoral bypass, Patients refusing mesh hernioplasty, Females in childbearing age who looks for further children, Patients unfit for surgery according to ASA criteria, Patients with a parastomal hernia, patient with a stoma and patients with uncontrolled diabetics, active smokers, and patients with COPD were excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zagazig University
Zagazig, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assisstant professor
Study Record Dates
First Submitted
December 16, 2023
First Posted
December 21, 2023
Study Start
December 1, 2022
Primary Completion
December 1, 2023
Study Completion
June 1, 2024
Last Updated
December 21, 2023
Record last verified: 2023-12