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

Incisional Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06178965
• Other study ID #: incisional hernia repair
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: December 2023
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 17
• Est. completion date: June 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia

Intervention

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.

Locations

Country	Name	City	State
Egypt	Zagazig University	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	detect black color at the incision site	the detection by vision	postoperative day 1 and 2
Secondary	detect pulge at incision site	detect by vision	from postoperative day 1 to 6 months postoperative