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
Protocol serial number	B.U.N. B14320072331
Sponsor	Royal Belgian Society of Surgery, Section of Abdominal Wall Surgery (BSAWS) (Belgium)
Funder	Royal Belgian Society of Surgery, Section of Abdominal Wall Surgery (BSAWS) (Belgium)

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

Primary study design	Observational
Study design	Prospective, multicentre, cohort, observational study
Secondary study design	Cohort study
Study type	Participant information sheet
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)
Study acronym	LITEKUP trial
Study objectives	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(s)	Leading Ethical Committee of the University Hospital Brussels (Universitair Ziekenhuis Brussel). Date of approval: 11/10/2007
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Count of steps 1 week before and 2 weeks after scheduled inguinal hernia repair, measured with an electronic pedometer.
Key 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)
Completion date	31/05/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	976
Key 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.
Key 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
Date of first enrolment	01/06/2008
Date of final enrolment	31/05/2012

Locations

Countries of recruitment

Belgium

Study participating centre

Laarbeeklaan 101

Brussels
1090
Belgium

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes