Clinical trial NCT04033055: Antalgic Efficacy of CycloMesh™ Soaked in Ropivacaine Hydrochloride in Uncomplicated Inguinal Hernia.
Official title: Interventional Study of Antalgic Efficacy of the CycloMesh™ Implant Soaked in Ropivacaine Hydrochloride 10 Mg/mL in the Treatment of Uncomplicated Inguinal Hernia. Randomized Comparative Study Versus CycloMesh™ Soaked in Physiological Saline Solution NaCl 9°/°°
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Lead sponsor: Quanta Medical
Sponsor class: INDUSTRY
Collaborators: name: Cousin Biotech
First posted: 2019-07-25
Enrollment: 304
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: CycloMesh is a polyester visceral implant functionalized by drug delivery systems directly on its surface, targeting a unique intervention, a slow anesthetic release and an in situ activity. Based on the fact that cyclodextrins are capable of forming inclusion complexes with amino-amide anaesthetic agents, ropivacaine and cyclodextrins were combined on a commercial visceral mesh.This enables CycloMesh to release ropivacaine for a sustained period in order to improve patient's comfort after inguinal hernia surgery.

The underlying hypothesis of this work is that clinical gain is achieved by adding a drug delivery system to visceral mesh for the local and prolonged delivery of ropivacaine. This should results in an improvement in quality of life, a reduction in pain and a faster returning to work following treatment of inguinal hernia by lichtenstein technique.


Eligibility criteria: Inclusion Criteria:

Disease-related criteria:

* Uncomplicated and non-recurrent unilateral symptomatic inguinal hernia with a surgical indication
* Bilateral inguinal hernia symptomatic on one side and requiring surgery on the symptomatic side
* Symptomatic, normal unilateral inguino-scrotal hernia (located above the middle of the inner thigh), uncomplicated and non-recurrent, with an indication for surgery by local inguinal approach without testicular redonation.
* Open surgery with Lichtenstein's technique;
* Programmed outpatient surgery;
* Surgery performed under general anesthesia.

Population-related criteria:

* Male subjects over 18 years old;
* Subjects who have given their free informed signed consent to participate in the study;
* Subjects who are affiliated to a social security system or have rights from a social security system.

Non inclusion Criteria:

Disease-related criteria:

* Strangulated inguinal or inguino-scrotal hernia;
* Bilateral inguinal hernia symptomatic on both sides and requiring surgery on both sides
* Chronic pain state (\> 3 months) and/or long term analgesics intake susceptible to hide or interfere with pain assessment;
* Hepatic or renal failure and any other pathology that could notably extend half-life of anaesthetics and analgesics products
* Signs of infection at the surgical site;
* Severe cardiopulmonary, hepatic or renal diseases
* Active ongoing malignant disease;

Product or device-related criteria:

* Known allergy or hypersensitivity to any of the constituents of the CycloMesh (Polyethylene terephthalate + Cyclodextrin) and/or subjects allergic to ropivacaine;
* Allergy to any drugs of the anesthesia protocol;

Population-related criteria:

* Drug or alcohol abuse (addiction: i.e. chronic alcoholism or active drug addiction)
* Daily intake of level I analgesics (Paracetamol, Aspirin, Ibuprofen...etc.), for \> 6 weeks.
* Use of corticosteroids within 24 hours prior to the surgery.
* Chronic use of antidepressants, anxiolytics, neuroleptics since 1 month or more,
* In case of occasional use, taking antidepressants, anxiolytics, neuroleptics in the 72 h prior to the intervention
* Unavailability during the study
* Participation in a clinical trial within 3 months prior to the initial visit.
* Psychiatric pathology or depressive disorder

Primary outcomes:
measure: Pain intensity after treatment of inguinal hernia by lichtenstein technique under general anesthetic will be assessed 6h post-operative using Visual Analogic Scale (VAS).
timeFrame: 6 hours post-surgery
Secondary outcomes:
measure: Pain intensity back to home (Day 0) and Day 1 to 3 will be assessed using a Visual Analogic Scale (VAS)
timeFrame: Back to home (Day 0) at 8pm and 10 pm, Twice a day (8 am and 8 pm) at Day 1, Day 2 and Day 3
measure: Pain intensity at Day 1 and Day 7 post-surgery will be assessed using a Visual Analogic Scale (VAS)
timeFrame: Day 1 and Day 7 post-surgery
measure: Pain intensity at 1 month post-surgery will be assessed using a Visual Analogic Scale (VAS)
timeFrame: 1 month post-surgery
measure: Hospitalization lenght (in hours)
timeFrame: 1 week post-surgery
measure: Duration of surgical time from the first incision until wound closure (in minutes)
timeFrame: At the moment of wound closure
measure: Evolution between inclusion and 24 months post-surgery with regard to quality of life
timeFrame: Inclusion and 1 month post-surgery 12 and 24 months post-surgery
measure: The amount of consumed analgesic will be assessed using post-operative data and data reported by the patient on a log book
timeFrame: 7 days post-surgery period
measure: Time to return to work or activity post-surgery
timeFrame: Day 1, Day 7 and 1 month post-surgery
measure: The rate of early recurrence (at 1 month postoperative) and at long term (12 and 24 months) will be assessed
timeFrame: All study period (24-months)
measure: Number of patients presenting at least one adverse event (AE)
timeFrame: All study period (24-months)
measure: Number of patients presenting at least one AE related to the the device implantation
timeFrame: All study period (24-months)
measure: Number of patients presenting at least one serious adverse event (SAE)
timeFrame: All study period (24-months)
measure: Total number of AE related to the device implantation, classified by type and organ
timeFrame: All study period (24-months)
measure: Satisfaction of the surgeon and unit staff regarding the use of CycloMesh will be evaluated using a satisfaction questionnaire
timeFrame: Day 0
measure: Pain intensity after treatment of inguinal hernia by lichtenstein technique under general anesthetic will be assessed 6h post-operative using Visual Analogic Scale (VAS).
timeFrame: 6 hours post-surgery
measure: The rate of patient with chronic pain at 12 and 24 months
timeFrame: 12-months after surgery and 24-months after surgery
measure: The rate of implant migration at 12 and 24 months
timeFrame: 12-months after surgery and 24-months after surgery
measure: The rate of foreign body sensation at 12 and 24 months postoperative
timeFrame: 12-months after surgery and 24-months after surgery
Other outcomes:
Locations:
city: Amiens
country: France
facility: Amiens Picardie university hospital
Study officials:
References: