Incisional Hernia Repair by Abdominal Wall Component Release With Contemporary Onlay Mesh Fixation

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Incisional Hernia; Onlay Mesh; Abdominal Wall Component Release
• Intervention / Treatment: Procedure: Incisional Hernia Repair by Abdominal Wall Component Release with Contemporary Onlay Mesh Fixation

Detailed Description

the surgical correction was done under general anesthesia. After scrubbing and draping, an elliptical incision was performed .

Open the hernia sac then reduce the contents with adhesolysis as required. subcutaneous flaps on both sides were created in a manner that permit to spread an 8 cm mesh after the closure of the abdominal wall. approximate the facia after trimming of its edges with clamps with a manner that allow 1to 2 cm overlap in the midline without tension.

In case of tension do selective myofascial advancement (sequential components release). Our steps would be first a unilateral posterior rectus sheath release (1-2 cm longuitodinal incision lateral to linea alba) and reassess, if tension still present, bilateral posterior sheath release should be performed.If tension still present, do a unilateral then bilateral external oblique release as required (1-2 cm lateral to the linea semilunaris along the length of the abdominal wall).

close the defect with prolene 1 then cover with onlay wide pore mesh fixation with 2/0 prolene. Close the skin after placement of 2 subcutaneous suction drains.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Zagazig, Egypt
    • Zagazig University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• - 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Abdominal Wall Component Release with Contemporary Onlay Mesh Fixation; 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; patients with incisional hernia will be operated by hernia reduction and sac closure followed by placement of onlay mesh after creating suitable flaps.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
detect black color at the incision site	the detection by vision	postoperative day 1 and 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
detect pulge at incision site	detect by vision	from postoperative day 1 to 6 months postoperative

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): December 1, 2023
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: December 16, 2023
• First Submitted That Met QC Criteria: December 16, 2023
• First Posted (Estimated): December 21, 2023

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 16, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: incisional hernia repair

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No