NCT06178965

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 21, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

December 21, 2023

Status Verified

December 1, 2023

Enrollment Period

1 year

First QC Date

December 16, 2023

Last Update Submit

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

OTHER

Abdominal Wall Component Release with Contemporary Onlay Mesh Fixation in patients with incisional hernia

Procedure: Incisional Hernia Repair by Abdominal Wall Component Release with Contemporary Onlay Mesh Fixation

Interventions

patients with incisional hernia will be operated by hernia reduction and sac closure followed by placement of onlay mesh after creating suitable flaps.

Abdominal Wall Component Release with Contemporary Onlay Mesh Fixation

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

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

Locations