- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03994588
Intraperitoneal Polypropylene Light Weight Wide Pore Soft Mesh Repair for Complex Ventral Hernia.
February 14, 2024 updated by: Raafat Yahia Afifi, Cairo University
Intraperitoneal Polypropylene Light Weight Wide Pore Soft Mesh Versus A. Double Mesh Intraperitoneal Repair for Complex Ventral Hernia: A Prospective Randomized Cohort Study.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
According to randomization policy, patients' will be allocated to two groups each one will include 30 subjects: Group I (the study group) in which the investigator will use a polypropylene wide pore soft mesh (Bard, USA).
Group II (the control group) in which the investigator will use the same polypropylene mesh in association with Vicryl mesh (Polyglactin 910, VM95, Ethicon, Belgium).
The mesh will be prepared by suturing the Vicryl and polypropylene mesh together after folding the edges (2 cm each) and its fixation with four full thickness corners Vicryl 2/0 stay sutures.
Another four sutures anchoring the overlapped edges together will be applied at the center of each edge, after that, the mesh will be inserted intraperitoneally in an oblong fashion in defects above the point midway between the umbilicus and symphysis pubis and in horizontal fashion in defects in the hypogastric region with the Vicryl part facing the bowel.
U sutures using polypropylene 0 will be applied through the whole thickness of the anterior abdominal wall in order to anchor the four angles of the mesh.
Then, the turned over edges of the mesh will be fixed to the inner aspect of the abdominal wall using interrupted full thickness U sutures or mesh stapler (fascia stapler, Medtronic (covidien), USA) according to availability.
The same technique will be used in the study group excluding the vicryl mesh.
Following mesh fixation, a tailored viable part of the sac will be closed over the mesh to separate it from the subcutaneous tissue in order to minimize seroma formation.
Follow-up data will be recorded in a proforma for each patient, noting intraoperative and postoperative complications and postoperative hospital-stay.
Each patient will be examined by the surgical team in the Outpatient Clinic at postoperative days 7, 15, and 30 to assess early complications, and at 3 months for one year and every 6 months for 2 years, to assess late complications when necessary after making the scheduled telephone communication.
Study Type
Interventional
Enrollment (Actual)
59
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Raafat Y Afifi, MD
- Phone Number: 00201001404257
- Email: raafatafifi@yahoo.com
Study Locations
-
-
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Cairo, Egypt
- Cairo University hospitals
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
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).
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: study arm
In this arm a light weight, wide pore, soft polypropylene mesh will be used for intraperitoneal hernia repair
|
The mesh will be inserted intraperitoneally for complex ventral hernia repair and fixed according the previously described ADMIR technique.
|
Active Comparator: control
in this arm a double mesh (vicryl + polypropylene mesh) will be used for intraperitoneal hernia repair.
|
The mesh will be inserted intraperitoneally for complex ventral hernia repair and fixed according the previously described ADMIR technique.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The development of persistent abdominal pain (VAS), intestinal obstruction or abdominal wall sinus or fistula formation.
Time Frame: one year
|
Manifestations of intestinal obstruction in the form of abdominal pain (VAS), abdominal distention, vomiting and absolute constipation
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one year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hernia recurrence.
Time Frame: three years
|
the development of clinically manifest or radiologically detected recurrence.
|
three years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Raafat Y Afifi, MD, Cairo University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 12, 2019
Primary Completion (Actual)
July 31, 2023
Study Completion (Actual)
July 31, 2023
Study Registration Dates
First Submitted
June 20, 2019
First Submitted That Met QC Criteria
June 20, 2019
First Posted (Actual)
June 21, 2019
Study Record Updates
Last Update Posted (Actual)
February 15, 2024
Last Update Submitted That Met QC Criteria
February 14, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- N-43-2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data can be shared at the end of the study.
IPD Sharing Time Frame
one year
IPD Sharing Access Criteria
email contact
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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