No registrations found.
ID
Source
Brief title
Health condition
(Endoscopic) hernia repair surgery/ (endoscopische) liesbreukchirurgie
Chronic pain/ Chronische pijnklachten
Sponsors and support
The Netherlands
The Netherlands
Intervention
Outcome measures
Primary outcome
Frequency of chronic pain after Totally Extraperitoneal (TEP) endoscopic hernia repair.
Secondary outcome
1. Recurrene Rate;
2. Mesh ‘feeling’;
3. Sensitivity disorders (such as hypo- or hyperaesthesia);
4. Sexual functioning related to pain;
5. Postoperative complications (such as wound infection/hematoma/urinary tract infection/hydrocele etc.);
6. Time to postoperative recovery (return to work and daily activities);
7. Occurrence of long-term complications (e.g. testicular atrofia).
Background summary
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.
Study objective
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.
Study design
Screening/Baseline, day 1, 1 week, 6 weeks, 3 months, 1 year, 2 year, 3 year after surgery.
Intervention
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.
N. Schouten
Zeist 3707 HL
The Netherlands
+31 (0)30 6989214
nelleke.schouten@gmail.com
N. Schouten
Zeist 3707 HL
The Netherlands
+31 (0)30 6989214
nelleke.schouten@gmail.com
Inclusion criteria
1. Male patients;
2. ≥ 18 year old;
3. Primary, unilateral, symptomatic, reducible hernia;
4. Totally Extraperitoneal (TEP) endoscopic hernia repair.
Exclusion criteria
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).
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2014 |
| NTR-old | NTR2131 |
| CCMO | NL30223.100.09 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON38149 |