In this trial the outcomes of an Ultrapro mesh after endoscopic hernia repair (TEP) will be compared with the outcomes of a heavyweight mesh (Prolene) after TEP hernia repair. The primary objective is to determine the effect of a lightweight mesh (…
ID
Source
Brief title
Condition
- Other condition
- Therapeutic procedures and supportive care NEC
Synonym
Health condition
liesbreuken
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Frequency of chronic pain 3 months after Totally Extraperitoneal (TEP)
endoscopic hernia repair. For the primary study outcome the Definition of the
International Association for the Study of Pain' is used, in which chronic pain
is defined as pain 'still present 3 months after the operation'.
Secondary outcome
Secondary objectives are: Frequency of early postoperative pain (1 week after
surgery), pain at 6 weeks, 1 year, 2 year and 3 year.
Recurrene Rate, Mesh *feeling*, Sensitivity disorders (such as hypo- or
hyperaesthesia), Sexual functioning related to pain, Postoperative
complications (such as wound infection/hematoma/urinary tract
infection/hydrocele etc.), Time to postoperative recovery (return to work and
daily activities), Occurrence of long-term complications (e.g. testicular
atrofia).
Background summary
Chronic pain following elective inguinal hernia repair is common. Approximately
14%-54% of patients still experience some degreee of inguinal pain several
years after succesful surgery (loos 2007).
In recent years, clinical research has focused therefore increasingly on
chronic pain and chronic dysesthesias after inguinal hernia repair.
In a review by Mattews et al it is stated that totally extraperitoneal (TEP)
endoscopic hernia repair (when performed by an experienced surgeon) has a
favorable effect on postoperative pain when compared to conventional (open)
hernia repair.
Moreover, recent studies suggest that a lightweight mesh may be associated with
less chronic postoperative pain compared to a heavyweight mesh.
A combination of Totally Extraperitoneal (TEP) Endoscopic hernia repair with a
lightweight mesh might therefore be the solution in the prevention of
postoperative pain.
A randomised controlled trial with long-term follow up in which the two types
of meshes (lightweight and heavyweight) are compared is considered to be
appropriate.
At the Inguinal Hernia Repair Centre Zeist (In Dutch: Liesbreukcentrum Zeist),
approximately 1100 laparoscopic hernia operations are performed every year by
experienced surgeons. This makes this Centre a perfect setting for a randomized
controlled trial like this.
Study objective
In this trial the outcomes of an Ultrapro mesh after endoscopic hernia repair
(TEP) will be compared with the outcomes of a heavyweight mesh (Prolene) after
TEP hernia repair. The primary objective is to determine the effect of a
lightweight mesh (Ultrapro) compared to a heavyweight (Prolene) mesh on chronic
postoperative pain 3 months after totally Extraperitoneal (TEP) endoscopic
hernia repair. The purpose is to determine which mesh is the better one in
preventing chronic pain.
Chronic postoperative pain is thereby defined as pain at the operation site
still existing >= 3 months after surgery.
Study design
Randomized controlled monocentre (specialized centre) trial: the follow-up is 3
years after surgery.
Intervention
Intervention 1: heavyweight mesh (Prolene):
The heavyweight mesh Prolene® is the standard used at a TEP hernia repair in
the Hernia Centre Zeist (Dutch: Liesbreukcentrum Zeist). Mesh characteristics
are:
Structure: monofilament with small pores
Polymer fiber: Polypropyleen
Weight: 80-85 g/m2
Intervention 2: lightweight mesh (Ultrapro):
50% of participants ('intervention' group) will be randomized to receive this
mesh. Mesh characteristics are:
Structure: Multifilament with large pores (3-4 mm)
Polymer fiber: Polypropylene (PP) + Monocryl component (Poliglecapron).
Weight: 28 g/m2 (part of polypropylene which is not absorbed)
The monocryl part (polyglecapron) is absorbed in 90-120 days due to hydrolysis;
a lightweight mesh with a pore size of 3-4 mm is what remains.
Study burden and risks
Both meshes (Ultrapro and Prolene) are already being used in endoscopic hernia
repair surgery. So we expect that there are no additional risks associated with
this trial compared to 'regular' hernia surgery and treatment. Peroperative and
perioperative care for patients who participate in this trial is also not
different from regular per- and perioperative care.
Professor Lorentzlaan 76,
3707 HL Zeist (postadres: postbus 1002, 3700 BA Zeist)
NL
Professor Lorentzlaan 76,
3707 HL Zeist (postadres: postbus 1002, 3700 BA Zeist)
NL
Listed location countries
Age
Inclusion criteria
Male patients
>= 18 year old
Primary, unilateral, symptomatic, reducible hernia
Totally Extraperitoneal (TEP) endoscopic hernia repair
Exclusion criteria
Bilateral hernia
Scrotal hernia
Recurrent hernia
Walking distance < 500 m.
Collagen disorders, such as Marfan Syndrome
Likely problems, in the judgment of the investigators, with maintaining follow-up
(e.g., patients with no fixed address or insufficient comprehension of
Dutch language will be excluded).
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL30223.100.09 |
| Other | op trialregister.nl: trial ID is NTR2131 |
| OMON | NL-OMON19969 |