Plain English Summary
Not provided at time of registration
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The Tilburg double-blind randomised controlled trial comparing inguinal hernia repair according to Lichtenstein and the transinguinal preperitoneal technique
Acronym
TULIP
Study hypothesis
The transinguinal preperitoneal (TIPP) technique will show reduction of chronic pain compared to the Lichtenstein technique.
Ethics approval
1. Medical Ethical Testing Committee (METC) of St Elisabeth Hospital and TweeSteden Hospital gave approval on the 28th November 2007 (ref: 0737)
2. Centrale Commissie Mensgebonden Onderzoek (CCMO) Central Committee for Research Involving Human Subjects gave approval on the 24th September 2007 (ref: NL16781.008.07)
Study design
Double-blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
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
Unilateral groin hernia
Intervention
All patients will be operated via anterior approach with a skin incision two centimetres above the Poupart ligament.
In half of the study population the groin hernia will be corrected according to the Lichtenstein technique. This is the reference treatment advised by the Dutch Society of Surgeons. The Lichtenstein technique will be attempted to present-day insights; a soft mesh will be used instead of the polypropylene mesh.
The other 150 inguinal hernia patients will be operated by the transinguinal preperitoneal (TIPP) technique with Polysoft® mesh. In this technique an inguinal incision 4 - 5 cm long is made, the external oblique aponeurosis is divided and the cord lifted on a tape. The cremaster muscle is divided around the internal orifice, but not stripped, and the sac is dissected. The technique of placement of the Polysoft® mesh into the preperitoneal space adapts anatomically to the type of hernia.
Type of hernia will be assessed using the European Hernia Society groin hernia classification. This classification is simple and easy to remember. The size of the hernia orifice is registered as 1 (less than or equal to 1 finger), 2 (1 - 2 fingers) or 3 (greater than or equal to 3 fingers) accompanied with L (lateral), M (medial) or F (femoral). All of the hernias will be primary (P) classified according to the inclusion criteria so recurrent (R) will not be assessed in our population.
In indirect hernias high dissection of the sac is performed and the sac is thus reduced in the preperitoneal space (PPS) through the internal ring. Blunt dissection is carried out in the PPS, through the internal orifice and is then extended deep to epigastric vessels and transverse fascia, in the direction of the pubic spine, beyond its level. The patch is introduced in the PPS via the internal orifice. In regional or local anaesthesia asking the patient to strain allows correct anatomical spreading of the mesh, which is applied to the deep aspect of the fascia. The assessment is done by asking the patient to strain and to cough. External oblique aponeurosis was repaired superficial to the cord to restore the normal anatomy.
In direct hernias, after division of the cremaster so as to check the internal orifice for an indirect sac, the transverse fascia is divided circularly around the hernia bulge and the sac is reduced. Blunt dissection is carried out in the PPS, medially in the direction of the pubic spine and laterally behind the epigastric vessels in direction of the iliac spine. The patch is introduced through the transverse fascia opening and spread in the PPS so as to cover all the weak inguinal area. When an indirect sac, even if it is small, is associated to the direct one, both sacs are dissected and reduced.
Total duration of treatment: 1 day in hospital on day of surgery. Outpatient department follow-up at 14 days, 3 months and 1 year post-operatively in both arms of trial.
Joint Sponsor:
TweeSteden Hospital (The Netherlands)
P.O. Box 90107
Tilburg
5000 LA
Netherlands
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Direct post-operative and chronic pain, measured post-operatively during hospital admission and at 14 days/3 months and one year; final measurement will be after follow up completion of the last patient in both groups.
Secondary outcome measures
1. Operation time
2. Post-operative complications
3. Hospital stay
4. Return to daily activities (e.g. work)
5. Recurrence
Measured post-operatively during hospital admission and at 14 days/3 months and one year; final measurement will be after follow up completion of the last patient in both groups.
Overall trial start date
01/12/2008
Overall trial end date
01/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Primary unilateral groin hernia
2. Aged greater than 18 years, either sex
3. American Society of Anaesthesiologists (ASA) classification 1 - 3
4. Signed informed consent letter
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300 patients
Participant exclusion criteria
1. Recurrent hernia
2. Aged less than 18 or greater than 80 years
3. Scrotal hernia(s)
4. ASA classification greater than 4
5. Acute incarcerated inguinal hernia(s)
6. Psychiatric disease or other reason making follow-up or questionnaires unreliable
Recruitment start date
01/12/2008
Recruitment end date
01/12/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
St Elisabeth Hospital
Tilburg
5022 GC
Netherlands
Sponsor information
Organisation
St Elisabeth Hospital (Netherlands)
Sponsor details
Hilvarenbeekseweg 60
Tilburg
5022 GC
Netherlands
g.koning@elisabeth.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
St Elisabeth Hospital (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
TweeSteden Hospital (Netherlands)
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
2009 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/19781069
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/22872429
Publication citations
-
Protocol
Koning GG, de Schipper HJ, Oostvogel HJ, Verhofstad MH, Gerritsen PG, van Laarhoven KC, Vriens PW, The Tilburg double blind randomised controlled trial comparing inguinal hernia repair according to Lichtenstein and the transinguinal preperitoneal technique., Trials, 2009, 10, 89, doi: 10.1186/1745-6215-10-89.
-
Results
Koning GG, de Vries J, Borm GF, Koeslag L, Vriens PW, van Laarhoven CJ, Health status one year after TransInguinal PrePeritoneal inguinal hernia repair and Lichtenstein's method: an analysis alongside a randomized clinical study., Hernia, 2013, 17, 3, 299-306, doi: 10.1007/s10029-012-0963-9.