| - candidate number | 2280 |
| - NTR Number | NTR790 |
| - ISRCTN | ISRCTN47267588 |
| - Date ISRCTN created | 28-dec-2006 |
| - date ISRCTN requested | 18-dec-2006 |
| - Date Registered NTR | 4-okt-2006 |
| - Secondary IDs | N/A |
| - Public Title | Pain after Kugel versus Lichtenstein repair: a randomized trial. |
| - Scientific Title | Pain after Kugel versus Lichtenstein repair: a randomized trial. |
| - ACRONYM | N/A |
| - hypothesis | The 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) studied | Inguinal hernia, Pain |
| - Inclusion criteria | Adult patients who had been referred for elective primary, unilateral inguinal hernia repair and gave informed consent. |
| - Exclusion criteria | An irreducible inguinoscrotal hernia or previous procedures using the preperitoneal approach. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | Single |
| - control | Active |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-dec-2004 |
| - planned closingdate | 1-okt-2005 |
| - Target number of participants | 172 |
| - Interventions | The Lichtenstein procedure and the Kugel procedure for inguinal hernias. |
| - Primary outcome | VAS pain score at three months postoperatively. |
| - Secondary outcome | VAS pain scores and consumed analgesics during the first two weeks postoperatively, Pain Disability Index scores, neuroligical disturbances. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | stopped: 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 |
| - Publications | World J Surg. 2007 Sep;31(9):1751-7; discussion 1758-9. Epub 2007 May 18. |
| - Brief summary | The 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) | |
| - RECORD | 4-okt-2006 - 11-sep-2008 |
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