TREPP compared to Lichtenstein's technique for inguinal hernia: what's best?

• Register: ISRCTN
• Last refreshed on: 4 December 2018
• Main ID: ISRCTN14511362
• Date of registration: 29/07/2016
• Prospective Registration: Yes
• Primary sponsor: Medical Center Leeuwarden
• Public title: TREPP compared to Lichtenstein's technique for inguinal hernia: what's best?
• Scientific title: Protocol for a randomised clinical trial comparing the Trans REctussheath PrePeritoneal repair (TREPP) versus Lichtenstein's technique for inguinal hernia
• Date of first enrolment: 01/01/2019
• Target sample size: 750
• Recruitment status: Recruiting
• URL: http://isrctn.com/ISRCTN14511362
• Study type: Interventional
• Study design: Multi-centre double-blind randomised parallel trial (Treatment)

Countries of recruitment

Netherlands

Contacts

• Name: Thomas Zwols

Key inclusion & exclusion criteria

Inclusion criteria:
1. Aged 18 years and over
2. ASA classification 1-3
3. Symptomatic primary unilateral inguinal hernia

Exclusion criteria:
1. Previous preperitoneal operations (e.g. prostatectomy, Caesarean section)
2. Bilateral hernias
2. Recurrent hernias
4. Incarcerated hernias (acute)
5. Inadequate mental state and/or IQ limitations to answer questionnaires
6. Mental disorders (DSM V)


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Primary unilateral inguinal hernia
Musculoskeletal Diseases
Primary unilateral inguinal hernia

Intervention(s)

Following provision of informed consent, participants are randomised to one of two groups.

Group 1: Participants undergo inguinal hernia repair according to the TREPP technique. To reach the preperitoneal space (PPS), a 5 cm transverse incision is made approximately 1 cm cranial to the pubic bone. The anterior rectus sheath is opened by transverse incision. After retraction of the muscle fibers medially, the inferior epigastric vein and artery are identified and retracted medially. The underlying transverse fascia is opened transversely as well. With a gentle movement, the PPS is dissected and a medial hernia may be reduced immediately. Using the iliac vessels as a landmark, the funiculus is identified with the spermatic cord, the testicular vessels and a possible lateral hernia. The latter (if present) may now be reduced. Using three long and thin retractors, a perfect overview of the PPS may be achieved and all possible hernia orifices (medial, lateral and/or femoral) can be visualized. The soft mesh is positioned in the PPS and covers the complete myopectineal orifice of Fruchaud. After deployment, the abdominal pressure keeps the mesh in position, without the necessity of any fixation. The anterior rectus sheath and the fascia of Scarpa are closed with Vicryl.

Group 2: Participants undergo inguinal hernia repair according to Lichtenstein's technique via anterior approach with a skin incision two centimetres above the Poupart ligament. The Lichtenstein technique will be adapted to present-day insights; a soft mesh will be used instead of the ‘heavy’ polypropylene mesh. The mesh will be positioned as onlay (or ‘inlay’, as it is, basically, positioned IN the inguinal canal). The skin will be closed the same way as the TREPP technique, using an intracutaneous technique with a resorbable wire.

The surgery will be between 15 and 45 minutes estimated for both techniques (TREPP and Lichtenstein). Prefe

Primary Outcome(s)

Chronic postoperative inguinal pain (CPIP) is measured using a visual analogue scale (VAS) in combination with the proposed Quantitative sensory testing (QST) at baseline, 6 weeks, 6 months and 1 year

Secondary Outcome(s)

1. Health status is measured using the Short Form 36 (SF-36), EuroQol5D (EQ-5D), Carolina comfort scale and Pain Disability index and a physical examination at baseline, 6 weeks, 6 months and 1 year
2. Cost-effectiveness of the interventions is completed by calculating all direct and/or indirect costs (hospital and societal related costs) at 12 months (this means: at the end of the trial, once the last patient fulfilled the final visit)

Secondary ID(s)

V1.2

Source(s) of Monetary Support

The Adriaan Metius Foundation, Surgical Cooperation Friesland, Medical Center Leeuwarden

Ethics review

Status:
Approval date:
Contact:

Not provided at time of registration

Results

• Results available: Yes
• Date Completed: 31/12/2021