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

NCT ID: NCT06352489

Last Updated: 2024-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2026-06-30

Brief Summary

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* 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.

Detailed Description

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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.

Conditions

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Ventral Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PCS with TAR

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.

Group Type ACTIVE_COMPARATOR

Posterior component separation technique.

Intervention Type 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 without TAR

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.

Group Type ACTIVE_COMPARATOR

Posterior component separation technique.

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Mahmoud Mohamed Yehya

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Samir A Ammar

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

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Mohamed M Yehya

Role: CONTACT

00201212405820

Mohamed E Bakiet

Role: CONTACT

00201020846778

References

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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.

Reference Type BACKGROUND
PMID: 2143588 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22607741 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33792765 (View on PubMed)

Other Identifiers

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Posterior component separation

Identifier Type: -

Identifier Source: org_study_id

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