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Trial registered on ANZCTR


Registration number
ACTRN12616000242426
Ethics application status
Approved
Date submitted
6/12/2015
Date registered
22/02/2016
Date last updated
22/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mesh fixation with glue in the inguinal hernia repair. Does it provide benefits to suture fixation?
Scientific title
Effect of N-Butyl-2 cyanoacrylate for mesh fixation in Lichtenstein hernioplasty on pain, surgical time, recurrence and complications.
Secondary ID [1] 288081 0
None
Universal Trial Number (UTN)
u1111-1177-3121
Trial acronym
FELIU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inguinal hernia 297534 0
Condition category
Condition code
Surgery 297190 297190 0 0
Surgical techniques
Musculoskeletal 297818 297818 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants are randomised to one of two procedures for hernia repair: 1) Lichtenstein tension-free hernioplasty using N-Butyl-2-cyanoacrylate for mesh fixing or 2) Lichtenstein tension-free hernioplasty using nonabsorbable sutures for mesh fixing.

The use of this adhesive is only in the fixation of the mesh. The mesh is fixed using a drop of the N-Butyl-2-cyanoacrylate adhesive in each location where normally a stitch would be placed.
Intervention code [1] 293391 0
Treatment: Surgery
Comparator / control treatment
The Lichtenstein tension-free mesh repair, which is an example of hernioplasty and is currently one of the most popular open inguinal hernia repair techniques.

Opening of the deep fascia of the thigh and exposure of the femoral canal to check for a femoral hernia. Division of the external oblique aponeurosis from the external ring laterally for up to 5 cm, safeguarding the ilioinguinal nerve.

Mobilization of the superior (safeguarding the iliohypogastric nerve) and inferior flaps of the external oblique aponeurosis to expose the underlying structures. Mobilization of the spermatic cord, along with the cremaster, including the ilioinguinal nerve, the genitofemoral nerve, and the spermatic vessels, opening of the coverings of the spermatic cord and identification and isolation of the hernia sac.
Inversion, division, resection, or ligation of the sac, as indicated; depending on the type of hernia and hernia sac. Placement and fixation of mesh. we set the prosthesis to the inguinal ligament with nonabsorbable suture, also place it around the spermatic cord creating a reinforcement to the internal inguinal ring.
Control group
Active

Outcomes
Primary outcome [1] 296795 0
Evaluation of acute pain. Using the visual analog scale for each patient assessment.
Timepoint [1] 296795 0
30 days, 3 months and 6 months after surgery
Secondary outcome [1] 319376 0
Incidence of chronic pain. Using the visual analog scale for each patient assessment.
Timepoint [1] 319376 0
Assessment 12 months, one year and two years after surgery.
Secondary outcome [2] 320506 0
Recurrence rate. We assess the recurrence of the hernia by physical examination at each visit , if we have doubts during the assessement, we ask an ultrasound.
Timepoint [2] 320506 0
Assessment 12 months, one year and two years after surgery

Eligibility
Key inclusion criteria
Patients with unilateral inguinal hernia more than 18 years, electively operated using the technique of Lichtenstein. Patients who accept their inclusion in the study
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient under 18 or over 80 years, bilateral hernia, emergency surgery other than the Lichtenstein technique. Patients who do not accept their inclusion in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Random. Single-blind. The nurse assistant takes a paper of sealed opaque envelope, indicating the group the patient belongs, just before placing the mesh.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Through a computer program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Analysis using SPSS 7.5-Windows (SPSS, Chicago, IL). Chi-2 and Fisher exact test was used for qualitative variables expressed as frequencies and Student t test for quantitative variables expressed as mean and standard deviation, after checking the normal distribution. Statistical significance was set at p <0.05.

We estimate the sample size on the basis of observations made previously by other researchers, who found differences between 1-3 points on the VAS scale in acute pain, and using a categorical variable (yes/no) chronic pain (pain 6 months after surgery) found a rate of 10% in suture group and 0 % adhesive group.

Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, 70 subjects in the first group and 70 are set out in the second to detect a difference equal to or greater than 1 unit on the VAS pain scale. It is assumed that the common standard deviation of 2 units. It has been estimated rate of loss to follow up of 10%.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
26/11/2013
Date of last participant enrolment
Anticipated
Actual
15/04/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
140
Recruitment outside Australia
Country [1] 7395 0
Spain
State/province [1] 7395 0
Barcelona

Funding & Sponsors
Funding source category [1] 292509 0
Hospital
Name [1] 292509 0
Consorci Sanitari de l'Anoia
Country [1] 292509 0
Spain
Primary sponsor type
Hospital
Name
Consorci Sanitari de l'Anoia
Address
Av Catalunya 11. Igualada. Postcode 08700. Barcelona. Spain
Country
Spain
Secondary sponsor category [1] 291218 0
None
Name [1] 291218 0
None
Address [1] 291218 0
None
Country [1] 291218 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293984 0
Comite Etico de Investigacion Clinica del Hospital Universitario de Bellvitge.
Ethics committee address [1] 293984 0
Feixa Llarga s/n L'Hospitalet de Llobregat
Ethics committee country [1] 293984 0
Spain
Date submitted for ethics approval [1] 293984 0
09/12/2014
Approval date [1] 293984 0
05/11/2015
Ethics approval number [1] 293984 0
AC178/14

Summary
Brief summary
Randomized Clinical Trial, in which they have included patients with unilateral inguinal hernia, elective surgery, over 18 years and agreed to be included.
Patients were randomized to one of two treatment groups: Mesh fixation with nonabsorbable sutures or fixation with n- butyl-2 - cyanoacrylate. They have been collected from the patient 's own variables and associated with the intervention.
The main objective is to assess the impact on acute pain, secondary objectives are to assess chronic pain and the incidence of hernia recurrence. Pain was assessed using the visual analog scale at each patient visit. Recurrent hernia has been evaluated by physical examination in consultation, in case of doubt has been requested inguinal ultrasound.

We observed lower incidence of acute pain in the group of mesh fixation with cyanoacrylate (p<0.05). There were no differences in the development of chronic pain or the incidence of hernia recurrence.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61998 0
Mr LUIS ALFONSO VEGA ROJAS
Address 61998 0
Mariano Cuiner Street 4. 1. 1. Igualada, Barcelona. Postcode 08700. Spain
Country 61998 0
Spain
Phone 61998 0
+34652727153
Fax 61998 0
Email 61998 0
[email protected]
Contact person for public queries
Name 61999 0
LUIS ALFONSO VEGA ROJAS
Address 61999 0
Mariano Cuiner Street 4. 1. 1. Igualada, Barcelona. Postcode 08700. Spain
Country 61999 0
Spain
Phone 61999 0
+34652727153
Fax 61999 0
Email 61999 0
[email protected]
Contact person for scientific queries
Name 62000 0
Josep Camps
Address 62000 0
Av Catalunya 7. Igualada Postcode 08700, Barcelona. Spain
Country 62000 0
Spain
Phone 62000 0
+34630140400
Fax 62000 0
Email 62000 0
[email protected]

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