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29 August 2008
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| [ Print-friendly version ] |
| Multicentre study of the reduction of steps (measured by an electronic pedometer) after 4 different types of repair for inguinal hernia |
| ISRCTN | ISRCTN34433965 |
| ClinicalTrials.gov identifier | |
| Public title | Multicentre study of the reduction of steps (measured by an electronic pedometer) after 4 different types of repair for inguinal hernia |
| Scientific title | Multicentre cohort study evaluating ambulatory activity reduction after LIchtenstein, laparoscopic Totally ExtraPeritoneal, KUgel patch or Polysoft repair of primary inguinal hernia (LITEKUP trial) |
| Acronym | LITEKUP trial |
| Serial number at source | B.U.N. B14320072331 |
| Study hypothesis | To compare the short-term functional outcome after four different techniques of inguinal hernia repair in an ambulatory setting, namely, the Lichtenstein repair, the laparoscopic totally extraperitoneal repair, the open retroperitoneal Kugel patch repair and the Polysoft® patch repair. |
| Ethics approval | Leading Ethical Committee of the University Hospital Brussels (Universitair Ziekenhuis Brussel). Date of approval: 11/10/2007 |
| Study design | Prospective, multicentre, cohort, observational study |
| Countries of recruitment | Belgium |
| Disease/condition/study domain | Inguinal hernia |
| Participants - inclusion criteria | Consecutive patients (both males and females, >18 years of age) with a diagnosis of primary unilateral inguinal hernia presenting in the participating centres for the surgical repair of their hernia in an ambulatory setting. |
| Participants - exclusion criteria |
1. Incarcerated inguinal hernia
2. Life expectancy less than two years 3. Pregnancy 4. American Society of Anaesthesiology (ASA) class IV or V 5. Extensive lower abdominal surgery or severe local inflammation 6. Inability to sign the informed consent. 7. Indication for other type of surgery for various reasons 8. Patients unable to walk (paralysed or bedridden patients) 9. Bilateral hernia repair 10. Large scrotal hernias 11. Concomitant abdominal surgery 12. Body mass index (BMI) >= 35 kg/m2 13. Liver cirrhosis (Child C) 14. Known abuse of alcohol or drugs 15. Ongoing long term analgesic or steroid treatment 16. Patients under clopidogrel or warfarin must be switched to subcutaneous (sc) low-molecular-weight (lmw) heparin 17. Severely compromised physical or psychological health, that in the investigator’s opinion will affect patient’s compliance 18. Concurrently participating in another clinical trial |
| Anticipated start date | 01/06/2008 |
| Anticipated end date | 31/05/2012 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 976 |
| Interventions |
This is an observational cohort study comparing the reduction in ambulatory activity (RAA) after four common techniques of inguinal hernia repair of patients with primary inguinal hernia. The four techniques are:
1. Lichtenstein repair 2. Laparoscopic totally extraperitoneal repair 3. Open retroperitoneal Kugel patch repair 4. Polysoft® patch repair Count of steps will be carried out 1 week before and 2 weeks after scheduled inguinal hernia repair, measured with an electronic pedometer. |
| Primary outcome measure(s) | Count of steps 1 week before and 2 weeks after scheduled inguinal hernia repair, measured with an electronic pedometer. |
| Secondary outcome measure(s) |
1. Recurrence rate after 12-24 months. This will be assessed by clinical examination during clinical follow-up after 2 weeks, 6, 12 and 24 months. Independent examination will be performed at 12 and 24 months to assess recurrence and chronic pain.
2. Acute pain at the affected groin side measured daily the week before, the day of and the first 2 weeks after surgery, using a visual analogue scale (VAS) indicating no pain at 0 mm and worst pain ever experienced at 100 mm. 3. Chronic groin pain syndrome at the operated side after 12-24 months. Classified as follows: No pain: no discomfort experienced Mild pain: defined to the patient as discomfort that did not limit activity, with a return to pre-hernia lifestyle Moderate pain: defined as pain preventing return to normal preoperative activities (i.e. inability to continue with prehernia activities such as golf, tennis and other sports, and inability to lift objects, without pain, that patient had been lifting before the hernia occurrence) Severe pain: pain that incapacitated the patient at frequent intervals or interfered with activities of daily living (i.e. pain constantly present or intermittently present but so severe as to impair normal activities, such as walking) |
| Sources of funding | Royal Belgian Society of Surgery, Section of Abdominal Wall Surgery (BSAWS) (Belgium) |
| Trial website | |
| Publications | |
| Contact name | Prof Yves Van Nieuwenhove |
| Address | Laarbeeklaan 101 |
| City/town | Brussels |
| Zip/Postcode | 1090 |
| Country | Belgium |
| Sponsor | Royal Belgian Society of Surgery, Section of Abdominal Wall Surgery (BSAWS) (Belgium) |
| Address |
Koninklijk Belgisch Genootschap voor Heelkunde
W. Churchill-laan 11/30 |
| City/town | Brussels |
| Zip/Postcode | 1180 |
| Country | Belgium |
| amb@skynet.be | |
| Sponsor website: | http://www.belsurg.org |
| Date applied | 29/05/2008 |
| Last edited | 20/06/2008 |
| Date ISRCTN assigned | 20/06/2008 |
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