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

NCT06352489 | Not Yet Recruiting

• 1 other identifier: Posterior component separation
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ventral Hernia

Outcome Measures

Primary Outcomes (1)

• Hernia recurrence

  develop ventral hernia recurrence

  six month after operation

Secondary Outcomes (1)

• post operative short term complications

  One month after operation

Study Arms (2)

PCS with TAR

ACTIVE COMPARATOR

The posterior component separation technique utilizes the retro-rectus space, accessed by incising the posterior rectus sheath and dissecting the posterior sheath between the internal oblique and transversus abdominis muscle.

Procedure: Posterior component separation technique.

PCS without TAR

ACTIVE COMPARATOR

by performing posterior component separation technique through inscion in the posterior rectus sheath and mesh placement in this plane without performing more advancement towards tranversus abdominis muscle.

Procedure: Posterior component separation technique.

Interventions

Posterior component separation technique. PROCEDURE

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.

PCS with TAR; PCS without TAR

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• patients with contraindication to long standing anesthesia.
• patients with emergency hernia situation.
• pregnant patients.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• 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.

  PMID: 2143588 BACKGROUND

• 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.

  PMID: 22607741 BACKGROUND

• 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.

  PMID: 33792765 BACKGROUND

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Samir A Ammar

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Mohamed M Yehya

CONTACT

00201212405820; mohammedyahya484@yahoo.com

Mohamed E Bakiet

CONTACT

00201020846778; Surgeonesmat@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2026
• Study Completion: June 1, 2026
• Last Updated: April 8, 2024

Record last verified: 2024-04