Condition category
Digestive System
Date applied
29/05/2008
Date assigned
20/06/2008
Last edited
20/06/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Yves Van Nieuwenhove

ORCID ID

Contact details

Laarbeeklaan 101
Brussels
1090
Belgium

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 measures

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

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 investigator’s opinion will affect patient’s 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

http://www.belsurg.org

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes