Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03994588 |
| Other study ID # |
N-43-2019 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 12, 2019 |
| Est. completion date |
July 31, 2023 |
Study information
| Verified date |
February 2024 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
