Primary obejective is the evaluation a ventral patch is associtaed with less complications than a conventional mesh for epigastric and umbilical hernias. Complications are defined as unexpected events necessitating a treatment within the period of…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
buikwandbreuken
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is number of complications.
A complication is defined as unexpected event related to the operation field
which necessitates a treatment within 3 months postoperatievly. Treatment can
be initiated by primar as well as general physician. These includes
- peroperative bleeding or other damage
- prescribed medication such as antibiotics and analgesics after discharge
other than paracetamol
- re-intervention for haematoma, abccess drainage, exploration due to pain /
early recurrence / intra-abdominal problems
- woundcare at least the equivalent of rinsing once a day
- hospital stay longer than expected or re-admission for observation
Secondary outcome
Pre-operative
Length, weigth, Verbal Descriptor Scale (VDS) pain at rest, during excercise,
VDS cosmetics, intensity of daily activities/work
Per-operative
Randomized device, incarceration, resection hernia sac, diameter hernia,
enlargment hernia, closure of fascia, presence of adhesions, operation
duration, VDS ease procedure, complications, reason for protocol deviations
Postoperative
Complications, Verbal Descriptor Scale (VDS) pain at rest, during excercise,
VDS cosmetics, recurrence,
Costs
Post-hoc computing based on number of vistis, operation duration, device and
complications related costs up to 2 years postoperatively.
Background summary
There is a tendency for the use of mesh in epigastric and umbilical hernia
repair as it is standard in the repair of other hernias. Mesh-based repair
reduces the recurrence rate of approximately 15-20% down to 3-10%. Whether or
not this also accounts for small hernias is unknown. A currently conducted
HUMP-trial will provide this information for specifically umbilical hernia less
than 2 cm's. A possible reason for still suturing small hernia could be the
challenge placing a mesh in the pre-peritoneal space.
A mesh, designed for this use, can be placed intra-peritoneally. An apporach is
laparoscopically which includes new openings in the fascia.
This probably has induced the innovation of so-called patches. A patch is a
mesh whch can be introduced open and pulled back against the abdominal wall.
Theoratically, these patches are specially useful for small hernias as less
dissection is required. Its feasability has been reported before, however, it
remains unclear this ease is associated with less complications. A surgeon may
favour a less complicated procedure, this however not a clinically important
parameter. Identifying a best procedure not only has consequences for around
4100 umbilical and 2400 epigastric hernias in The Netherlands, also for
frequently encountered incisional hernia such as on previous trocar sites.
Study objective
Primary obejective is the evaluation a ventral patch is associtaed with less
complications than a conventional mesh for epigastric and umbilical hernias.
Complications are defined as unexpected events necessitating a treatment within
the period of three months postoperatively. Secondary endpoints are pain,
cosmetics, operation duration and costs.
Study design
Design = patient-blinded randomized trial
Type = superiority study
Setting = national multicenter trial
Intervention
All procedures will be performed under general anesthesia. Addition of lokal
anestheticum is advocated. Profylactic antibiotics only on indication. Use of
drapes or drains is not advocated. Enlarging hernia and closure of fascia over
mesh is allowed.
Conventional repair: incision para-umbilical or at epigastric site. Dissection
subcutanously to fascia. Mobilising hernia sac. Opening for inspection is
allowed. Reposition of sac. Dissection pre-peritoneally space. Placing
polypropylene mesh, minimum size 6 cm's. Fixation with non-absorbabale sutures.
Patch repair; opening hernia sac, ensuring no adhesions at peritoneum. Placing
patch against abdominal waal. Fixation to fascia. Standard mesh is PROCEED tm
VENTRAL PATCH (Ethicon, Norderstedt, Germany).
Study burden and risks
Risks are similar to daily practice
Extent of burden is 1 hour for fulfilling questionnaires within study time of 2
years
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Listed location countries
Age
Inclusion criteria
- single primary umbilical or epigastric hernia
- size less than 3 cm (2 fingers)
Exclusion criteria
- age < 18 years
- not capable to understand and complete questionnaires
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL33995.060.10 |