To assess the outcomes of endoscopic hernia repair (TEP) after implantation of a lightweight mesh (Ultrapro) versus a heavyweight mesh (Prolene). The hypothesis is that an endoscopic hernia repair with implantation of a lightweight mesh results in…
ID
Bron
Verkorte titel
Aandoening
(Endoscopic) hernia repair surgery/ (endoscopische) liesbreukchirurgie
Chronic pain/ Chronische pijnklachten
Ondersteuning
The Netherlands
The Netherlands
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Frequency of chronic pain after Totally Extraperitoneal (TEP) endoscopic hernia repair.
Achtergrond van het onderzoek
In this trial a lightweight mesh (Ultrapro) will be compared with a standard heavyweight mesh (Prolene) on chronic postoperative pain and quality of life after endoscopic inguinal hernia repair.
Doel van het onderzoek
To assess the outcomes of endoscopic hernia repair (TEP) after implantation of a lightweight mesh (Ultrapro) versus a heavyweight mesh (Prolene). The hypothesis is that an endoscopic hernia repair with implantation of a lightweight mesh results in less chronic postoperative pain than endoscopic repair with implantion of a heavyweight (standard Prolene) mesh.
Onderzoeksopzet
Screening/Baseline, day 1, 1 week, 6 weeks, 3 months, 1 year, 2 year, 3 year after surgery.
Onderzoeksproduct en/of interventie
Arm 1 (intervention group): lightweight mesh (Ultrapro):
50% of participants will be randomized to receive this mesh.
Mesh characteristics are:
1. Structure: Multifilament with large pores (3-4 mm);
2. Polymer fiber: Polypropylene (PP) + Monocryl component (Poliglecapron);
3. 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.
Arm 2 (Control group): heavyweight mesh (Prolene):
The heavyweight mesh Prolene® is the standard used at a TEP hernia repair in the Hernia Centre Zeist (Dutch: Liesbreukcentrum Zeist). 50% of participants will be randomized to receive this mesh.
Mesh characteristics are:
1. Structure: monofilament with small pores;
2. Polymer fiber: Polypropyleen;
3. Weight: 80-85 g/m2.
Publiek
N. Schouten
Zeist 3707 HL
The Netherlands
+31 (0)30 6989214
nelleke.schouten@gmail.com
Wetenschappelijk
N. Schouten
Zeist 3707 HL
The Netherlands
+31 (0)30 6989214
nelleke.schouten@gmail.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Male patients;
2. ≥ 18 year old;
3. Primary, unilateral, symptomatic, reducible hernia;
4. Totally Extraperitoneal (TEP) endoscopic hernia repair.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Bilateral hernia;
2. Scrotal hernia;
3. Recurrent hernia;
4. Walking distance < 500 m;
5. Collagen disorders, such as Marfan Syndrome;
6. 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).
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL2014 |
NTR-old | NTR2131 |
CCMO | NL30223.100.09 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |
OMON | NL-OMON38149 |