Health TrialsbyHealthPanel

ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair

ConditionsVentral HerniaAbdominal Wall Defect
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland

About this trial

This study investigates on the effect of two different operative techniques to treat abdominal wall hernias.

The goal of this clinical trial is to learn if the eTEP (Extended totally extraperitoneal repair) technique leads to a better outcome than the IPOM (Intraperitoneal onlay mesh) technique.

The main questions it aims to answer are:

* pain after the operation * rate of complications * rate of recurrence and reoperations * quality of life.

Participants will:

Either be operated using the eTEP or the IPOM technique. Be followed up either in person or via email / phone call at day 1, day 7, day 14, 6 weeks, 6 months, 1, 3 and 5 years after the surgery to asses the above-stated main and some more outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient age >18 years

Informed consent obtained

Primary or incisional ventral hernia

Epigastric, umbilical or infraumbilical ventral hernias with transversal diameter >1cm and </= 4cm, +/- rectus diastasis which doesn't demand specific treatment

Disqualifiers

Subxyphoidal or suprapubic hernias

precedent hernia treatment with mesh placement in the retromuscular space

liver disease defined by the presence of ascites

end-stage renal disease requiring dialysis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Extended totally extraperitoneal repair

    Procedure/Surgery

    The anterior rectus sheath is incised and the retromuscular space is entered through the rectus muscle fibres. The capnopreperitoneum is established and blunt dissection of the retromuscular space is performed. Two additional laparoscopic ports are established 8-10cm lateral to the linea alba caudally to the initial port. The medial border of the rectus sheath is incised and the preperitoneal space below the linea alba is dissected. The hernia orifice is also dissected from peritoneum and preperitoneal fatty tissue. The medial border of the right retromuscular space is then incised and blunt dissection is performed. The hernia orifice is closed with barbed suture and a synthetic mesh is placed on the posterior sheath of the dissected space (intended Mesh-defect ratio 16). The mesh is fixed non-traumatically using glubran glue or no fixation at all.

  • Intraperitoneal onlay mesh

    Procedure/Surgery

    Capnoperitoneum is established through left sided subcostal Veress-Needle punction. Three laparoscopic ports are placed 8-10cm lateral to the linea alba usually on the patient's left side. The peritoneum is incised and detached from the umbilical and supraumbilical linea alba. The peritoneum including the hernia sac and preperitoneal fat is resected. The hernia orifice is then closed using a barbed suture. A coated mesh is than placed to the ventral abdominal wall covering the closed hernia orifices (intended mesh-defect-ratio: 16). The mesh is fixed with two transfacial absorbable sutures and several absorbable tackers placed in double crown technique around the hernia orifice. The capnoperitoneum is released, the trocars removed and the fascia closed with an absorbable suture. The skin is sutured with absorbable sutures.

Treatment groups

138 Participants
are divided into 2 treatment groups
Group A: eTEP (Extended totally extraperitoneal repair)Experimental treatment 1 intervention
Group B: IPOM (intraperitoneal onlay mesh)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

primary outcome: pain numeric rating scale (NRS)

pain, measured on the numeric rating scale (NRS) 0 - 10 24 hours after the surgical procedure.

Time frame
24 hours
2

pain outcome using the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity Short Form 3a

pain, measured using the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity Short Form 3a 24 hours after the surgical procedure

Time frame
24 hours

Secondary outcomes

1

pain mid-term

pain, measured on the visual analog scale (NRS) 0 - 10 and using the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity Short Form 3a after 7days, 14 days, 6 weeks, 6 and 12 months (NRS 0-10)

Time frame
12 months
2

recurrence and reoperation

Long-term outcome at 3 and 5 years with assessment of the number of patients with clinical and / or radiological recurrences and with assessment of the number of patients who needed reoperations for either recurrences or other reasons such as mechanical bowel obstructions

Time frame
5 years
3

LOS

Length of hospital stay

Time frame
30 days
4

Functional recovery

Functional recovery measured using the European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire at 7 and 14 days, 6 weeks, 6 months, 1, 3 and 5 years. The questionnaire uses 5 questions describing the patients health \& abilities on that particular day and a visual analogue scale question (0 = worst, 100 = best) on the patients health on that particular day.

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Basel, Switzerland

Lead sponsor

St. Clara Hospital, Basel, Switzerland

Collaborator

Innklinikum Altötting, Germany

Collaborator

Hôpital du Valais

Collaborator

Source ClinicalTrials.gov
Apply now