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

NCT03994588 | Completed

• 1 other identifier: N-43-2019
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Complex ventral hernia; Polypropylene soft mesh; Intraperitoneal repair; Recurrence; Loss of Domain

Outcome Measures

Primary Outcomes (1)

• The development of persistent abdominal pain (VAS), intestinal obstruction or abdominal wall sinus or fistula formation.

  Manifestations of intestinal obstruction in the form of abdominal pain (VAS), abdominal distention, vomiting and absolute constipation

  one year

Secondary Outcomes (1)

• Hernia recurrence.

  three years

Study Arms (2)

study arm

ACTIVE COMPARATOR

In this arm a light weight, wide pore, soft polypropylene mesh will be used for intraperitoneal hernia repair

Procedure: Intraperitoneal Mesh hernia repair

control

ACTIVE COMPARATOR

in this arm a double mesh (vicryl + polypropylene mesh) will be used for intraperitoneal hernia repair.

Procedure: Intraperitoneal Mesh hernia repair

Interventions

Intraperitoneal Mesh hernia repair PROCEDURE

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

control; study arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients between 18 and 65 years of age, ASA physical status I - III with complex ventral hernia (defect width above 10 cm, loss of domain above 20 %, recurrent hernia and/or associated with fistula or abdominal wall sinuses).

You may not qualify if:

• Age below 18 and above 65 years. The maximum age limit would be 65 years because in our previous studies morbidity was higher in older age group (36, 37).
• Body mass index greater than 45 kg/m2 or weight above 100 kg.
• Pregnancy.
• Associated non treated abdominal malignancy.
• Unstable coronary artery disease, congestive heart failure.
• Significant renal or hepatic impairment;
• Severe bronchopulmonary disease, including chronic obstructive pulmonary disease and obstructive sleep apnea.
• Diabetics with Hb A1c above 7.5.
• Subjects with loss of domain above 20 % who didn't respond to pre-operative progressive pneumoperitoneum.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Hernia, Ventral; Recurrence

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Raafat Y Afifi, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient will be blinded to the study group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of General Surgery - primary investigator

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 21, 2019
• Study Start: July 12, 2019
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: one year
• Access Criteria: email contact

Locations

EG (1)