Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
B.U.N. B14320072331
Study information
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
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
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Inguinal hernia
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Count of steps 1 week before and 2 weeks after scheduled inguinal hernia repair, measured with an electronic pedometer.
Secondary outcome measures
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)
Overall trial start date
01/06/2008
Overall trial end date
31/05/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
976
Participant 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 investigators opinion will affect patients compliance
18. Concurrently participating in another clinical trial
Recruitment start date
01/06/2008
Recruitment end date
31/05/2012
Locations
Countries of recruitment
Belgium
Trial participating centre
Laarbeeklaan 101
Brussels
1090
Belgium
Sponsor information
Organisation
Royal Belgian Society of Surgery, Section of Abdominal Wall Surgery (BSAWS) (Belgium)
Sponsor details
Koninklijk Belgisch Genootschap voor Heelkunde
W. Churchill-laan 11/30
Brussels
1180
Belgium
amb@skynet.be
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Royal Belgian Society of Surgery, Section of Abdominal Wall Surgery (BSAWS) (Belgium)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list