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Not yet recruitingNCT06352489Updated Apr 8, 2024

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

An interventional study of Posterior component separation technique. in Ventral Hernia, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-08.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2026, 6 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.
Read the detailed 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.

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Conditions studied

  • Ventral Hernia

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03

In context

Hernia, Ventral

230 studies on the registry are indexed under Hernia, Ventral; 45 are open to participants now.

This study's planned enrollment of 30 is below the median of 90 across 153 interventional studies indexed under Hernia, Ventral.

Browse Hernia, Ventral studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. patients with to long standing anesthesia.
  2. patients with emergency hernia situation.
  3. pregnant patients.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    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.

    Procedure: Posterior component separation technique.

  • Active comparator
    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.

    Procedure: Posterior component separation technique.

Interventions

  • ProcedurePosterior 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.

06

What researchers measure

Primary outcomes

  1. Hernia recurrence

    develop ventral hernia recurrence

    Time frame: six month after operation

Secondary outcomes

  1. post operative short term complications

    wound infection(hematoma, seroma) and wound dehiscence

    Time frame: One month after operation

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 2143588 ↗
  • 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. PubMed 22607741 ↗
  • 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. PubMed 33792765 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06352489
Lead sponsor
Assiut University
Responsible party
Mohamed Mahmoud Mohamed Yehya (Assistant lecturer, Assiut University) — Principal investigator
First posted
Apr 8, 2024
Start date
May 1, 2024 (estimated)
Primary completion
May 2026 (estimated)
Completion
Jun 2026 (estimated)
Last update
Apr 8, 2024

Study contacts

Mohamed M Yehya
Contact
mohammedyahya484@yahoo.com
00201212405820
Mohamed E Bakiet
Contact
Surgeonesmat@gmail.com
00201020846778
Samir A Ammar
study director · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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