Evaluation of Posterior Component Separation Technique in the Management of Complex Ventral Hernia.

Ventral Hernia Clinical Trial

Official title:

Posterior Component Separation in the Management of the Complex Ventral Hernia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06352489
• Other study ID #: Posterior component separation
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: June 2026

Study information

• Verified date: April 2024
• Source: Assiut University
• Contact: Mohamed M Yehya
• Phone: 00201212405820
• Email: mohammedyahya484[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

- Assess short term outcome of posterior component separation technique(PCS) including the regain of the physiological function of the abdominal wall. - Detect most common post operative complications related to AWR techniques in a 6 months duration after operation.

Description:

posterior component separation(PCS) is one of the surgical techniques used in abdominal wall reconstruction plan foe management of relatively complex ventral hernia ,which cannot be treated with the conventional surgical way. With or without transverses abdominis release(TAR) technique, (PCS) became widely accepted as surgical technique specially for large sized hernia defect, previous multiple laparotomies or unhealth abdominal soft tissue. This study has a primary outcome which is detection of recurrence rate in patients under went posterior component separation technique in a period of 6 month after operation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• patients with complex ventral hernia with contraindication to the conventional surgical therapy.

Exclusion Criteria:

1. patients with contraindication to long standing anesthesia.

2. patients with emergency hernia situation.

3. pregnant patients.

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Ventral Hernia

Intervention

Procedure:
• Posterior component separation technique.
By dividing the posterior rectus sheath, a posterior plane is reached which can be advanced by dividing the transversus abdominis muscle with reinforcement of the midline with synthetic mesh.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

Kockerling F, Reinpold W, Schug-Pass C. [Abdominal wall hernias part 2 : Operative treatment techniques]. Chirurg. 2021 Aug;92(8):755-768. doi: 10.1007/s00104-021-01383-z. Epub 2021 Apr 1. German. — View Citation

Novitsky YW, Elliott HL, Orenstein SB, Rosen MJ. Transversus abdominis muscle release: a novel approach to posterior component separation during complex abdominal wall reconstruction. Am J Surg. 2012 Nov;204(5):709-16. doi: 10.1016/j.amjsurg.2012.02.008. Epub 2012 May 16. — View Citation

Ramirez OM, Ruas E, Dellon AL. "Components separation" method for closure of abdominal-wall defects: an anatomic and clinical study. Plast Reconstr Surg. 1990 Sep;86(3):519-26. doi: 10.1097/00006534-199009000-00023. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hernia recurrence	develop ventral hernia recurrence	six month after operation
Secondary	post operative short term complications	wound infection(hematoma, seroma) and wound dehiscence	One month after operation