Multicentre study of the reduction of steps (measured by an electronic pedometer) after 4 different types of repair for inguinal hernia

ISRCTN ISRCTN34433965
DOI https://doi.org/10.1186/ISRCTN34433965
Secondary identifying numbers B.U.N. B14320072331
Submission date
29/05/2008
Registration date
20/06/2008
Last edited
20/06/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Yves Van Nieuwenhove
Scientific

Laarbeeklaan 101
Brussels
1090
Belgium

Study information

Study designProspective, multicentre, cohort, observational study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleMulticentre cohort study evaluating ambulatory activity reduction after LIchtenstein, laparoscopic Totally ExtraPeritoneal, KUgel patch or Polysoft repair of primary inguinal hernia (LITEKUP trial)
Study acronymLITEKUP trial
Study objectivesTo 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(s)Leading Ethical Committee of the University Hospital Brussels (Universitair Ziekenhuis Brussel). Date of approval: 11/10/2007
Health condition(s) or problem(s) studiedInguinal hernia
InterventionThis 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 typeOther
Primary outcome measureCount of steps 1 week before and 2 weeks after scheduled inguinal hernia repair, measured with an electronic pedometer.
Secondary outcome measures1. 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 study start date01/06/2008
Completion date31/05/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants976
Key inclusion criteriaConsecutive 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.
Key exclusion criteria1. 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
Date of first enrolment01/06/2008
Date of final enrolment31/05/2012

Locations

Countries of recruitment

  • Belgium

Study participating centre

Laarbeeklaan 101
Brussels
1090
Belgium

Sponsor information

Royal Belgian Society of Surgery, Section of Abdominal Wall Surgery (BSAWS) (Belgium)
Hospital/treatment centre

Koninklijk Belgisch Genootschap voor Heelkunde
W. Churchill-laan 11/30
Brussels
1180
Belgium

amb@skynet.be
http://www.belsurg.org
ROR logo https://ror.org/04yy1mz94

Funders

Funder type

Hospital/treatment centre

Royal Belgian Society of Surgery, Section of Abdominal Wall Surgery (BSAWS) (Belgium)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan
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