Primary Objective: Investigate if a release of the EOM in patients undergoing a VHR with retromuscular mesh gives (long term) loss of function of the AW .
ID
Source
Brief title
Condition
- Soft tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: Patients will be tested on several items
related to the function of the EOM in the AW. These items are; Peak torque
(Nm), peak torque per bodyweight of the abdominal wall, measured with the
Biodex S4 pro. Backpain measured with the Quebec Back Pain Disability Scale and
health related quality of life with the Carolina Comfort Scale.
Secondary outcome
n.v.t.
Background summary
Rationale: With an occurrence rate up to 29%, is an incisional hernia (IH) a
common complication of abdominal surgery. An elective reconstructive surgery is
necessary when the hernia causes pain, limitation of daily life function,
complications and poor cosmetics.
One more often used technic for complex IH is the (endoscopic) components
separation technique ((E)CTS). This technic is based on enlargement of the
abdominal wall surface by separation and advancement of the muscular layers by
releasing the external oblique muscle (EOM). Release of the EOM is likely to
give a disadvantage on the function of the AW, as well in strength as in
function. This is likely to give complains/constrains for the patient.
The aim of this study is to compare the function of the AW and the long term
complains in patients how had and ventral hernia repair (VHR) with
retromuscular mesh with or without release of the EOM.
Study objective
Primary Objective: Investigate if a release of the EOM in patients undergoing a
VHR with retromuscular mesh gives (long term) loss of function of the AW .
Study design
Study design: Observational study.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: Patients will have one hour of tests without any
risks.
Wesselmanlaan 25
Helmond 5707 HA
NL
Wesselmanlaan 25
Helmond 5707 HA
NL
Listed location countries
Age
Inclusion criteria
The operated population:
- The operation was a ventral hernia repair with retromuscular mesh without release the external oblique muscle (EOM) or with bilaterally release of the EOM. (criteria only for the operated population)
- Operation is conducted more than 6 months ago.
The operated and healthy population:
- Able to for fill questionnaires
- Able to execute tests for the AW
- Living within 25 kilometre of the test location.
Exclusion criteria
The operated population:
- The operation is complicated
- Participant of the PHASIX-trail.
- Recurrence of the ventral hernia.
The operated and healthy population:
- Objective back problems (before operation)
Design
Recruitment
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 | NL61669.100.17 |