ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair

Ventral Hernia Clinical Trial

— ALPINE  

Official title:

ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair - the Randomized Controlled ALPINE Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06367309
• Other study ID #: 2023 - 02357
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 30, 2024
• Est. completion date: December 31, 2030

Study information

• Verified date: April 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Fiorenzo Angehrn, MD
• Phone: 0041 61 777 73 17
• Email: fiorenzo.angehrn[@]clarunis.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 138
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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
• If multiple hernias: cumulative transversal diameter </= 4cm
• Considered eligible for minimally-invasive approach

Exclusion Criteria:

• 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
• need of an emergency surgery
• pregnancy
• need of rectus diastasis treatment intraoperatively Criteria for participating surgeons
• Each participating surgeon has performed 20 or more laparoscopic IPOM procedures and 20 or more eTEP procedures.

Related Conditions & MeSH terms

• Abdominal Wall Defect
• Hernia
• Hernia, Ventral
• Ventral Hernia

Intervention

Procedure:
• Extended totally extraperitoneal repair
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
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.

Locations

Country	Name	City	State
Switzerland	St. Clara Hospital	Basel	Basel-Stadt

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Innklinikum Altötting, Germany, St. Clara Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	primary outcome: pain numeric rating scale (NRS)	pain, measured on the numeric rating scale (NRS) 0 - 10 24 hours after the surgical procedure.	24 hours
Primary	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	24 hours
Secondary	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)	12 months
Secondary	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	5 years
Secondary	LOS	Length of hospital stay	30 days
Secondary	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.	5 years
Secondary	Adverse events	Intraoperative adverse events (Bleeding, conversion rate, injury to bowel structures) Postoperative adverse events (ileus, seroma, hematoma, Surgical site infections (SSI), pulmonary embolism) according to Clavien-Dindo Classification and scored according to the Comprehensive Complication Index (CCI) up to 30 days after surgery.	30 days
Secondary	Quality of life (SF 12)	Quality of life using the short form-12 (SF-12) questionnaire at 7 and 14 days, 6 weeks, 6 months, 1, 3 and 5 years.; The 12-item Short Form Survey (SF-12) is a general health questionnaire that was first published in 1995 as part of the Medical Outcomes Study (MOS). The SF-12 was constructed using questions drawn from each of the 8 dimensions of the MOS 36 item Short Form Survey (SF-36).; Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12).; The score ranges from 0 - 100, with a higher score indicating better physical and mental health functioning.	5 years