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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.
Hypothesis:
Methods:
350 patients with inguinal hernia undergone Lichtenstein operation in day-case surgery setting. Mesh fixation is performed using 2 methods: cyanoacrylate glue: Histoacrylâ„¢ (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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Histoacryl | Experimental | Intervention: Lichtenstein Hernioplasty with Histoacrylâ„¢(cyanoacrylate glue 0.5 ml) for mesh fixation (Optileneâ„¢ mesh 60 g/m2 (B. Braun)) |
|
| Suture | Experimental | Intervention: Lichtenstein Hernioplasty with Sutures (polypropylene 2/0) to fix the Optileneâ„¢ mesh 60 g/m2 (B. Braun) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lichtenstein Hernioplasty with Histoacryl | Procedure | Procedure/Surgery: Lichtenstein Hernioplasty with Histoacryl: 0.5 ml of cyanoacrylate glue is used for mesh fixation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute Postoperative Pain | pain scores (VAS 0-10) after surgery | 30 days |
| Operating Time | operating time needed to perform hernioplasty | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Complications | Complications related to procedure and assessed according to Clavien-Dindo Classification | 30 days |
| Early Recurrence Rate | Inguinal hernia recurrence rate after 1 year follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Hoyuela, MD | Hospital Plató | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Plató | Barcelona | Barcelona | 08006 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2916733 | Background | 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. | |
| Background | Amid PK, Lichtenstein IL. Long-term results and current status of the Lichtenstein open tension-free hernioplasty. Hernia 1998; 2: 89-94 | ||
| 19638912 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 26, 2019 | |
| Reset | Jan 13, 2020 | |
| Release | Mar 9, 2023 | |
| Reset | Dec 8, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 26, 2019 | Jan 13, 2020 | |||
| Mar 9, 2023 |
| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004659 | Enbucrilate |
| D013537 | Sutures |
| ID | Term |
|---|---|
| D003487 | Cyanoacrylates |
| D000179 | Acrylates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Lichtenstein Hernioplasty with Sutures | Procedure | Procedure/Surgery: Lichtenstein Hernioplasty with Sutures: non-absorbable suture (polypropylene 2/0) is used for mesh fixation Other Name: prolene 2-0 |
|
| 1 year |
| Chronic Pain | Pain scores (0-10) after 1-year follow-up | 1 year |
| Late Recurrence Rate | Inguinal hernia recurrence rate after 5 years follow-up | 5 years |
| Result |
| 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. |
| 28218406 | Derived | Hoyuela 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. |
| Dec 8, 2023 |
| D009930 |
| Organic Chemicals |
| D009570 | Nitriles |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D014014 | Tissue Adhesives |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D053831 | Surgical Fixation Devices |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |