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Intraperitoneal Polypropylene Light Weight Wide Pore Soft Mesh Repair for Complex Ventral Hernia.

NCT03994588 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2024-02-15

No results posted yet for this study

Summary

Complex ventral hernia is a challenging problem well known to be associated with occurrence of serious complications. The major problems encountered in such cases Include: loss of domain with subsequent increase of intra-abdominal pressure after repair, the huge musculo-fascial defect and skin scarring with possible skin viability problem resulting from the dissection of skin flaps. There is no unified accepted evidence-based approach for its repair and is attended with a high recurrence rate that may reach up to 67%. In a previous study using the ADMIR technique of intraperitoneal repair and after a long-term follow-up the investigator was able to reduce the recurrence rate to 4% after an average follow up period of 142 months. In the current study the investigator will use the same technique of intraperitoneal mesh repair comparing the polypropylene light weight, wide pore, soft mesh with a double mesh using the same polypropylene mesh and a vicryl mesh as a protective layer against the bowel. If it is proven as effective as the mesh with protective layer and with no increased risk of morbidity, this will result in marked reduction of the cost of treatment by nearly 90 % and will abolish the waiting list of patients as the polypropylene mesh is readily available.

Conditions

  • Ventral Hernia

Interventions

PROCEDURE

Intraperitoneal Mesh hernia repair

The mesh will be inserted intraperitoneally for complex ventral hernia repair and fixed according the previously described ADMIR technique.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Raafat Y Afifi, MD · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-12
Primary Completion
2023-07-31
Completion
2023-07-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03994588 on ClinicalTrials.gov