Lichtenstein technique versus transinguinal preperitoneal mesh prosthesis (TIPP): less chronic pain?
| ISRCTN | ISRCTN93798494 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93798494 |
| Secondary identifying numbers | N/A |
- Submission date
- 12/11/2008
- Registration date
- 23/12/2008
- Last edited
- 26/03/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Giel G Koning
Scientific
Scientific
St Elisabeth Hospital
Department of Surgery
Hilvarenbeekseweg 60
Tilburg
5022 GC
Netherlands
Study information
| Study design | Double-blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The Tilburg double-blind randomised controlled trial comparing inguinal hernia repair according to Lichtenstein and the transinguinal preperitoneal technique |
| Study acronym | TULIP |
| Study objectives | The transinguinal preperitoneal (TIPP) technique will show reduction of chronic pain compared to the Lichtenstein technique. |
| Ethics approval(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/12/2008 |
| Completion date | 01/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 300 patients |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2008 |
| Date of final enrolment | 01/12/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
St Elisabeth Hospital
Tilburg
5022 GC
Netherlands
5022 GC
Netherlands
Sponsor information
St Elisabeth Hospital (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Hilvarenbeekseweg 60
Tilburg
5022 GC
Netherlands
| g.koning@elisabeth.nl | |
| Website | http://www.elisabeth.nl |
"ROR" |
https://ror.org/04gpfvy81 |
Funders
Funder type
Hospital/treatment centre
St Elisabeth Hospital (Netherlands)
No information available
TweeSteden Hospital (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 25/09/2009 | Yes | No | |
| Results article | results | 01/06/2013 | Yes | No |
