- To examine the safety and feasibility (i.e. technical end result) of using OviTex core PGA during VMR - To assess perioperative complications- To assess 90-day morbidity
ID
Source
Brief title
Condition
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To examine the safety and feasibility of using OviTex core PGA during VMR.
Secondary outcome
Not applicable
Background summary
Minimal-invasive ventral mesh rectopexy (VMR) is a widely accepted treatment
for patients suffering from rectal prolapse. Choice of material used in VMR
remains subject of debate. Currently, the most widely used mesh in VMR is
polypropylene and has shown good results regarding recurrence, mesh exposure
and functional outcome. Although complication rates are low, the risk of
fistulation, erosion and dyspareunia are serious complications and form a
reason to opt for biological mesh. High-quality literature of synthetic versus
biological mesh is lacking, but does not stop resistance against synthetic mesh
from growing. The available literature does not suggest a better nor worse
performance of biologic mesh (Biodesign or Permacol) over synthetic
polypropylene mesh regarding risk on recurrence and functional outcome. There
might be a lower risk on mesh related complications.
OviTex is a biologic mesh that is designed to reinforce weakened tissue. It is
fabricated from sterile ovine (sheep) extracellular matrix. The material is
similar to Biodesign mesh but is available at a lower cost. OviTex would be a
good alternative for polypropylene in VMR. In the search for the most optimal
surgical mesh for VMR, OviTex should therefore be investigated. Although it has
been used for some patients in VMR, there is no literature on OviTex in VMR to
date. A pilot study should be conducted first to test the feasibility and
safety in this surgery.
Study objective
- To examine the safety and feasibility (i.e. technical end result) of using
OviTex core PGA during VMR
- To assess perioperative complications
- To assess 90-day morbidity
Study design
Prospective double-centre observational pilot study with 15 patients
Intervention
Minimal-invasive ventral mesh rectopexy with an OviTex mesh
Study burden and risks
Although OviTex has not been used on a large scale for VMR before, the strength
of OviTex meets that of the current standardly used synthetic meshes. Patients
that participate could possibly benefit from the lower synthetic load inserted
in their bodies which might bring a lower risk on mesh related complications.
Based on current literature on biologic mesh it cannot be expected that these
patients will have a higher nor lower risk on recurrence compared to synthetic
mesh. We have been noticing an aversion to synthetic mesh in a proportion of
our patients. With OviTex, those patients can be helped now too, which could
benefit their health and quality of life.
Maatweg 3
Amersfoort 3813 TZ
NL
Maatweg 3
Amersfoort 3813 TZ
NL
Listed location countries
Age
Inclusion criteria
Indication for ventral mesh rectopexy
Informed consent for OviTex mesh
Age of 18 years or older
Exclusion criteria
Mental incompetence
Allergy to ovine rumen.
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 | NL74593.100.20 |