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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03994588
Recruitment Status : Recruiting
First Posted : June 21, 2019
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Raafat Yahia Afifi, Cairo University

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.

Condition or disease Intervention/treatment Phase
Ventral Hernia Procedure: Intraperitoneal Mesh hernia repair Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: The patient will be blinded to the study group allocation.
Primary Purpose: Treatment
Official Title: Intraperitoneal Polypropylene Light Weight Wide Pore Soft Mesh Versus A. Double Mesh Intraperitoneal Repair for Complex Ventral Hernia: A Prospective Randomized Cohort Study.
Actual Study Start Date : July 12, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Hernia recurrence. [ Time Frame: three years ]
    the development of clinically manifest or radiologically detected recurrence.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994588


Contacts
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Contact: Raafat Y Afifi, MD 00201001404257 raafatafifi@yahoo.com

Locations
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Egypt
Cairo University Hospitals Recruiting
Cairo, Egypt
Contact: Raafat Y Afifi, MD    01001404257    raafatafifi@yahoo.com   
Contact: Mohsen Ibrahim, MD       kasralainirec@gmail.com   
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Raafat Y Afifi, MD Cairo University
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Responsible Party: Raafat Yahia Afifi, Clinical Professor of General Surgery - primary investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03994588    
Other Study ID Numbers: N-43-2019
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data can be shared at the end of the study.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: one year
Access Criteria: email contact

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Raafat Yahia Afifi, Cairo University:
Complex ventral hernia
Polypropylene soft mesh
Intraperitoneal repair
Recurrence
Loss of Domain
Additional relevant MeSH terms:
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Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal