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THE EFFECT OF MESH TYPE (ULTRAPRO VERSUS PROLENE) ON POSTOPERATIVE PAIN AND WELL-BEING FOLLOWING TOTALLY EXTRAPERITONEAL (TEP) LAPAROSCOPIC HERNIA REPAIR: A RANDOMIZED CONTROLLED TRIAL.


- candidate number6781
- NTR NumberNTR2131
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-dec-2009
- Secondary IDsNL30223.100.09 METC CCMO
- Public TitleTHE EFFECT OF MESH TYPE (ULTRAPRO VERSUS PROLENE) ON POSTOPERATIVE PAIN AND WELL-BEING FOLLOWING TOTALLY EXTRAPERITONEAL (TEP) LAPAROSCOPIC HERNIA REPAIR: A RANDOMIZED CONTROLLED TRIAL.
- Scientific TitleTHE EFFECT OF MESH TYPE (ULTRAPRO VERSUS PROLENE) ON POSTOPERATIVE PAIN AND WELL-BEING FOLLOWING TOTALLY EXTRAPERITONEAL (TEP) LAPAROSCOPIC HERNIA REPAIR: A RANDOMIZED CONTROLLED TRIAL.
- ACRONYMTULP
- hypothesisTo 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.
- Healt Condition(s) or Problem(s) studiedChronic pain, Hernia repair surgery
- Inclusion criteria1. Male patients;
2. ≥ 18 year old;
3. Primary, unilateral, symptomatic, reducible hernia;
4. Totally Extraperitoneal (TEP) endoscopic hernia repair.
- Exclusion criteria1. 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).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2010
- planned closingdate1-jul-2011
- Target number of participants950
- InterventionsArm 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.
- Primary outcomeFrequency of chronic pain after Totally Extraperitoneal (TEP) endoscopic hernia repair.
- Secondary outcome1. 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).
- TimepointsScreening/Baseline, day 1, 1 week, 6 weeks, 3 months, 1 year, 2 year, 3 year after surgery.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. N. Schouten
- CONTACT for SCIENTIFIC QUERIESDrs. N. Schouten
- Sponsor/Initiator Diakonessenhuis Zeist
- Funding
(Source(s) of Monetary or Material Support)
Diakonessenhuis Zeist
- PublicationsN/A
- Brief summaryIn 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.
- Main changes (audit trail)
- RECORD3-dec-2009 - 12-mrt-2010


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