Aim of this study is to see if the use of an anti-adhesive medical device, the FlexiSurge, is safe to use against adhesions that arise after open abdominal surgery.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
vorming van adhesies na buikchirurgie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Evaluation of Adverse Events reported during the study
Secondary outcome
Time to discharge; post discharge follow up; implant handling and macroscopical
features of the FlexiSurge Adhesion Barrier; Incidence, severity and extent of
the adhesions formed
Background summary
Postsurgical adhesions are a recognized clinical problem and can affect a
majority of patients undergoing abdominal surgery. Fibrous tissue bands may
start forming between surrounding tissue and organs or between organs, due to
prosthetic, foreign materials, or other intrinsic and extrinsic factors which
potentially can lead to major mid-term and long-term complications such as
chronic pain, intestinal obstruction or secondary female infertility.
There are several prevention methods for reducing or avoiding adhesion
formation after surgery. Most commonly, a barrier is placed around the treated
tissue at the end of the surgery. In this way the growth of fibrous tissue from
one trauma site (organ or surrounding tissue) to another traumatized or healthy
site is interrupted and the adhesion formation halted.
The use of this FlexiSurge Adhesion Barrier may thus lead to a significant
reduction in the incidence, severity and extent of adhesion formation after
major abdominal surgery.
Study objective
Aim of this study is to see if the use of an anti-adhesive medical device, the
FlexiSurge, is safe to use against adhesions that arise after open abdominal
surgery.
Study design
A prospective, multicenter clinical study.
Intervention
All patients will receive the standard of care before and after laparotomy. In
addition, the patients will receive the FlexiSurge medical device as
anti-adhesion barrier.
Study burden and risks
The normal risks that can occur with open abdominal surgery include thrombosis,
lung inflammation, bleeding, pain and wound infections.
In this study, no additional invasive procedures need to be performed. All
standard procedures that are the basis for a laparotomy will be applied.
However, half of the participating subjects will also receive a FlexiSurge
anti-adhesion medical device during the laparotomy. Furthermore, a pregnancy
test needs to be performed.
The possible risks of the medical device used in this research in this form
are not yet known. Since the medical device will be regarded as foreign and is
biodegradable, it is plausible that a mild tissue reaction occurs during the
decomposition process of the medical device by enzymes of the body.
Kernhemseweg 2
Ede 6718 ZB
NL
Kernhemseweg 2
Ede 6718 ZB
NL
Listed location countries
Age
Inclusion criteria
elective colectomy
elective colectomy with temporary stoma placement, followed by elective stoma reversal
elective liver first surgery, followed by elective surgical colectomy
ASA score 1-3
Exclusion criteria
previous surgery through abdominal incision
patients with a known history of adhesiolysis
BMI <=19 or >=35
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 | NL44765.068.13 |