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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06352489
Other study ID # Posterior component separation
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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