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Pain after Kugel versus Lichtenstein repair: a randomized trial.


- candidate number2280
- NTR NumberNTR790
- ISRCTNISRCTN47267588
- Date ISRCTN created28-dec-2006
- date ISRCTN requested18-dec-2006
- Date Registered NTR4-okt-2006
- Secondary IDsN/A 
- Public TitlePain after Kugel versus Lichtenstein repair: a randomized trial.
- Scientific TitlePain after Kugel versus Lichtenstein repair: a randomized trial.
- ACRONYMN/A
- hypothesisThe open preperitoneal approach in inguinal hernia repair might have the benefit of a mesh in the preferred space without the disadvantages of an endoscopic procedure.
- Healt Condition(s) or Problem(s) studiedInguinal hernia, Pain
- Inclusion criteriaAdult patients who had been referred for elective primary, unilateral inguinal hernia repair and gave informed consent.
- Exclusion criteriaAn irreducible inguinoscrotal hernia or previous procedures using the preperitoneal approach.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2004
- planned closingdate1-okt-2005
- Target number of participants172
- InterventionsThe Lichtenstein procedure and the Kugel procedure for inguinal hernias.
- Primary outcomeVAS pain score at three months postoperatively.
- Secondary outcomeVAS pain scores and consumed analgesics during the first two weeks postoperatively, Pain Disability Index scores, neuroligical disturbances.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES S. Nienhuijs
- CONTACT for SCIENTIFIC QUERIES S. Nienhuijs
- Sponsor/Initiator Canisius Wilhelmina hospital
- Funding
(Source(s) of Monetary or Material Support)
Canisius-Wilhelmina hospital
- PublicationsWorld J Surg. 2007 Sep;31(9):1751-7; discussion 1758-9. Epub 2007 May 18.
- Brief summaryThe open preperitoneal approach in inguinal hernia repair, like the Kugel procedure, might have the benefit of a mesh in the preferred space without the disadvantages of an endoscopic procedure. Therefore, a total of 172 patients with primary inguinal hernia was randomised to undergo either the standard procedure of Lichtenstein or Kugel hernioplasty. Primary endpoint was pain three months postoperatively, as persistent chronic pain is the most prominent complication of inguinal hernia repair. Other collected data included visual analogue scale pain scores and consumed analgesics during the first two weeks postoperatively, identification nerves in the operative field, neurological examination at three months, pain description by the patient and Pain Disability Index score.
- Main changes (audit trail)
- RECORD4-okt-2006 - 11-sep-2008


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