Modified "Open Intraperitoneal Mesh" Technique of Incisional Ventral Hernia Repair

Recurrent Ventral Hernia Clinical Trial

Official title:

Modified "Open Intraperitoneal Mesh" Technique of Incisional Ventral Hernia Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01953302
• Other study ID #: 24011983
• Status: Completed
• Phase: N/A
• Start date: May 2010
• Est. completion date: May 2014

Study information

• Verified date: April 2017
• Source: Varazdin General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Ventral hernias, primary and recurrent, are major surgical challenge. We aim to investigate efficacy of modified technique of ventral hernias repair: an "open intraperitoneal mesh" technique.

Description:

We analyzed early postoperative complications (EPCs; wound infection, hematoma, and seroma) and late postoperative complications (recurrence) in 124 patients operated for IHs and recurrent IHs (RIHs) using our new technique. Our technique involved repairing hernias by preserving the hernia sac, which was later used to conceal the mesh that replaced the abdominal wall defect, thus dividing the mesh from subcutaneous tissue.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients aged 18 years or older

• American Society of Anesthesiologists physical status I, II, III

Exclusion Criteria:

• refusal of the patients to give informed consent

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Incisional Ventral Hernia
• Recurrent Ventral Hernia

Intervention

Procedure:
• modified "open mesh technique"
We positioned mesh intraperitoneally so it can provide adequate mechanical support to the weakened abdominal wall. We also preserved hernia sack to conceal the mesh.

Locations

Country	Name	City	State
Croatia	Varazdin General Hospital	Varazdin

Sponsors (1)

Lead Sponsor	Collaborator
Varazdin General Hospital

Country where clinical trial is conducted

Croatia, 

References & Publications (1)

Pajtak A, Stare R, Biskup I, Lukic A, Skorjanec S, Hrzenjak K. A modified open intraperitoneal mesh (Garestin) technique for incisional ventral hernia repair. Asian J Surg. 2017 Jul;40(4):278-284. doi: 10.1016/j.asjsur.2016.02.001. Epub 2016 May 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Early Postoperative Complications (Wound Infections, Seroma, Hematoma)	we counted number of patinetns with wound infection, seroma, hematoma that occured in the early postoperative time	four weeks after the surgery
Secondary	Number of Patients With Postoperative Hernia Recurrence		up to 36 months after the surgery