Inguinal HerniaHistoacryl1NCT02632097
Histoacryl™ vs. Suture for Mesh Fixation in Lichtenstein Hernioplasty: A Randomized Prospective Double-Blinded Study
A study testing Lichtenstein Hernioplasty with Histoacryl and Lichtenstein Hernioplasty with Sutures in people with Inguinal Hernia, run by Hospital Plató at 1 site in Spain.
Trial summary
This is a prospective, randomized double-blinded study to find out if mesh fixation with n-butyl-2-cyanoacrylate (NBCA) are more painless than conventional mesh fixation with sutures in inguinal hernia operation (Lichtenstein procedure) in day-case surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Lichtenstein Hernioplasty with Histoacryl and Lichtenstein Hernioplasty with Sutures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2013to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unilateral inguinal hernia
- primary hernia
Who cannot join
- femoral hernia
- recurrent inguinal hernia
- immunosuppression (including corticosteroids, radiotherapy, chemotherapy)
- chronic renal failure (hemodialysis)
- active infection
- pregnancy
- allergy to polypropylene
- patient's refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Prospective Double-Blinded Study of Histoacryl™Mesh Fixation Compared to Conventional Non-absorbable Suture Fixation During Lichtenstein Hernioplasty
This is a prospective, randomized double-blinded study to find out if mesh fixation with n-butyl-2-cyanoacrylate (NBCA) are more painless than conventional mesh fixation with sutures in inguinal hernia operation (Lichtenstein procedure) in day-case surgery. Our hypothesis is that glue fixation is safe, simple and fast method compared to conventional Lichtenstein technique.
Read the detailed description
Hypothesis:
- To use glue (instead of sutures) for mesh fixation during open hernioplasty causes a lower immediate postoperative pain.
- The use of Histoacryl is associated to a lower postoperative complications rate.
- The use of Histoacryl is not associated to a higher hernia recurrence rate.
Methods:
350 patients with inguinal hernia undergone Lichtenstein operation in day-case surgery setting. Mesh fixation is performed using 2 methods: cyanoacrylate glue: Histoacryl™ (n=175: Group H), and non-absorbable sutures: polypropylene 2/0 (n=175: Group S). Operative time and pain scores, immediate postoperative outcome are followed 1, 7, 30 days and 1 and 5 years postoperatively.
Surgeon doesn't know previously which fixation method will be used in each patient. This method (glue or sutures) is decided intraoperatively, when mesh is placed, using a blind randomization code (www.randomizer.org) Patients are discharged (day-case surgery) if adequate pain control, oral tolerance and spontaneous diuresis is achieved, and after examination by the surgeon in order to discard immediate complications. Postoperative oral treatment is prescribed to patients of both groups: dexketoprofen 25 mg/8 h + paracetamol 1 gr/8.
Follow-up is performed at the medical office by a blind observer (third surgeon) who didn't participate in the surgical procedure, at 1 day, 7 days, 30 days, 1 year and annually thereafter. Pain is measured using a VAS scale (0-10).
Operative data (including operating time, complications, hospital stay, etc.), early and late complications, acute and chronic pain and recurrence rate will be recorded.
- Conditions
- Inguinal Hernia
- Being tested
- Lichtenstein Hernioplasty with Histoacryl, Lichtenstein Hernioplasty with Sutures
- Keywords
- inguinal hernia, mesh fixation, glue, cyanoacrylate, Lichtenstein, ambulatory surgery
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lichtenstein Hernioplasty with HistoacrylProcedure or surgery
Procedure/Surgery: Lichtenstein Hernioplasty with Histoacryl:
0.5 ml of cyanoacrylate glue is used for mesh fixation
Lichtenstein Hernioplasty with SuturesProcedure or surgery
Procedure/Surgery: Lichtenstein Hernioplasty with Sutures: non-absorbable suture (polypropylene 2/0) is used for mesh fixation Other Name: prolene 2-0
| Study group | Role | What they receive |
|---|---|---|
| Histoacryl | Experimental | Intervention: Lichtenstein Hernioplasty with Histoacryl™(cyanoacrylate glue 0.5 ml) for mesh fixation (Optilene™ mesh 60 g/m2 (B. Braun)) Receives: Procedure: Lichtenstein Hernioplasty with Histoacryl |
| Suture | Experimental | Intervention: Lichtenstein Hernioplasty with Sutures (polypropylene 2/0) to fix the Optilene™ mesh 60 g/m2 (B. Braun) Receives: Procedure: Lichtenstein Hernioplasty with Sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Postoperative Pain
pain scores (VAS 0-10) after surgery
Measured: 30 days
Operating Time
operating time needed to perform hernioplasty
Measured: 30 days
Secondary outcomes (4)
Postoperative Complications
Complications related to procedure and assessed according to Clavien-Dindo Classification
Measured: 30 days
Early Recurrence Rate
Inguinal hernia recurrence rate after 1 year follow-up
Measured: 1 year
Chronic Pain
Pain scores (0-10) after 1-year follow-up
Measured: 1 year
Late Recurrence Rate
Inguinal hernia recurrence rate after 5 years follow-up
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startMar 2013
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Plató
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Hoyuela, MD, Principal investigator, Hospital Plató
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632097
- Sponsor's protocol ID
- Histoacryl1
- Acronym
- Histoacryl1
- Status last verified
- Mar 2017
- First submitted
- 13 Dec 2015
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lichtenstein IL, Shulman AG, Amid PK, Montllor MM. The tension-free hernioplasty. Am J Surg. 1989 Feb;157(2):188-93. doi: 10.1016/0002-9610(89)90526-6.
PubMed 2916733Amid PK, Lichtenstein IL. Long-term results and current status of the Lichtenstein open tension-free hernioplasty. Hernia 1998; 2: 89-94
Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
PubMed 19638912Hoyuela C, Juvany M, Carvajal F, Veres A, Troyano D, Trias M, Martrat A, Ardid J, Obiols J, Lopez-Cano M. Randomized clinical trial of mesh fixation with glue or sutures for Lichtenstein hernia repair. Br J Surg. 2017 May;104(6):688-694. doi: 10.1002/bjs.10488. Epub 2017 Feb 20.
PubMed 28218406
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Double-Blinded Study of Histoacryl™Mesh Fixation Compared to Conventional Non-absorbable Suture Fixation During Lichtenstein Hernioplasty
- ClinicalTrials.gov ID
- NCT02632097
- Acronym / sponsor ID
- Histoacryl1 / Histoacryl1
- Conditions
- Inguinal Hernia
- Keywords
- inguinal hernia, mesh fixation, glue, cyanoacrylate, Lichtenstein, ambulatory surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- Hospital PlatóUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 16 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomized double-blinded study to find out if mesh fixation with n-butyl-2-cyanoacrylate (NBCA) are more painless than conventional mesh fixation with sutures in inguinal hernia operation (Lichtenstein procedure) in day-case surgery. Our hypothesis is that glue fixation is safe, simple and fast method compared to conventional Lichtenstein technique.
Detailed description
Hypothesis:
- To use glue (instead of sutures) for mesh fixation during open hernioplasty causes a lower immediate postoperative pain.
- The use of Histoacryl is associated to a lower postoperative complications rate.
- The use of Histoacryl is not associated to a higher hernia recurrence rate.
Methods:
350 patients with inguinal hernia undergone Lichtenstein operation in day-case surgery setting. Mesh fixation is performed using 2 methods: cyanoacrylate glue: Histoacryl™ (n=175: Group H), and non-absorbable sutures: polypropylene 2/0 (n=175: Group S). Operative time and pain scores, immediate postoperative outcome are followed 1, 7, 30 days and 1 and 5 years postoperatively.
Surgeon doesn't know previously which fixation method will be used in each patient. This method (glue or sutures) is decided intraoperatively, when mesh is placed, using a blind randomization code (www.randomizer.org) Patients are discharged (day-case surgery) if adequate pain control, oral tolerance and spontaneous diuresis is achieved, and after examination by the surgeon in order to discard immediate complications. Postoperative oral treatment is prescribed to patients of both groups: dexketoprofen 25 mg/8 h + paracetamol 1 gr/8.
Follow-up is performed at the medical office by a blind observer (third surgeon) who didn't participate in the surgical procedure, at 1 day, 7 days, 30 days, 1 year and annually thereafter. Pain is measured using a VAS scale (0-10).
Operative data (including operating time, complications, hospital stay, etc.), early and late complications, acute and chronic pain and recurrence rate will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Histoacryl | Experimental | Procedure: Lichtenstein Hernioplasty with HistoacrylIntervention: Lichtenstein Hernioplasty with Histoacryl™(cyanoacrylate glue 0.5 ml) for mesh fixation (Optilene™ mesh 60 g/m2 (B. Braun)) |
| Suture | Experimental | Procedure: Lichtenstein Hernioplasty with SuturesIntervention: Lichtenstein Hernioplasty with Sutures (polypropylene 2/0) to fix the Optilene™ mesh 60 g/m2 (B. Braun) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- unilateral inguinal hernia
- primary hernia
Key exclusion criteria (8 listed)
- femoral hernia
- recurrent inguinal hernia
- immunosuppression (including corticosteroids, radiotherapy, chemotherapy)
- chronic renal failure (hemodialysis)
- active infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lichtenstein Hernioplasty with HistoacrylProcedure/Surgery: Lichtenstein Hernioplasty with Histoacryl: 0.5 ml of cyanoacrylate glue is used for mesh fixation | Procedure or surgery | Histoacryl |
| Lichtenstein Hernioplasty with SuturesProcedure/Surgery: Lichtenstein Hernioplasty with Sutures: non-absorbable suture (polypropylene 2/0) is used for mesh fixation Other Name: prolene 2-0 | Procedure or surgery | Suture |
Primary outcome
Acute Postoperative Pain
Time frame: 30 days
pain scores (VAS 0-10) after surgery
Operating Time
Time frame: 30 days
operating time needed to perform hernioplasty
4 secondary outcomes
Postoperative Complications
Time frame: 30 days
Early Recurrence Rate
Time frame: 1 year
Chronic Pain
Time frame: 1 year
Late Recurrence Rate
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Background: PubMed 2916733Lichtenstein IL, Shulman AG, Amid PK, Montllor MM. The tension-free hernioplasty. Am J Surg. 1989 Feb;157(2):188-93. doi: 10.1016/0002-9610(89)90526-6.
- BackgroundAmid PK, Lichtenstein IL. Long-term results and current status of the Lichtenstein open tension-free hernioplasty. Hernia 1998; 2: 89-94
- Results publication: PubMed 19638912Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
- Derived from this study: PubMed 28218406Hoyuela C, Juvany M, Carvajal F, Veres A, Troyano D, Trias M, Martrat A, Ardid J, Obiols J, Lopez-Cano M. Randomized clinical trial of mesh fixation with glue or sutures for Lichtenstein hernia repair. Br J Surg. 2017 May;104(6):688-694. doi: 10.1002/bjs.10488. Epub 2017 Feb 20.
- Individual participant dataSharing planned: No
Related trials for Inguinal Hernia
Recruiting
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
Inguinal Hernia
Recruiting
Watchful Waiting Versus Immediate Repair for Occult Contralateral Inguinal Hernias.
Inguinal Hernia Bilateral, Inguinal Hernia Unilateral
Recruiting
Primary Sac Abandonment and Distal Sac Fixation vs Complete Sac Dissection for Inguinoscrotal Hernias
Seroma, Inguinal Hernias
Recruiting
Comparing Two Laparoscopic Techniques for Hernia Repair in Children
Inguinal Hernia
Not yet recruiting
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
Inguinal Hernia, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Hoyuela, MD principal investigator
Hospital Plató
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lichtenstein Hernioplasty with Histoacryl and Lichtenstein Hernioplasty with Sutures in people with Inguinal Hernia, run by Hospital Plató at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Postoperative Pain (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02632097, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.