Comparison of Two Mesh/Fixation Concepts for Laparoscopic Ventral and Incisional Hernia Repair

Hernia, Abdominal Clinical Trial

Official title:

COMPARISON OF TWO DIFFERENT CONCEPTS OF MESH AND FIXATION TECHNIQUE IN THE LAPAROSCOPIC OPERATIONS FOR VENTRAL AND INCISIONAL HERNIA - A RANDOMIZED CONTROLLED MONOCENTER TRIAL.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02233569
• Other study ID #: PHvsVS
• Status: Terminated
• Phase: N/A
• First received: August 29, 2014
• Last updated: September 5, 2014
• Start date: November 2012
• Est. completion date: February 2014

Study information

• Verified date: September 2014
• Source: Polish Hernia Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: The Central Register of Clinical Trials
• Study type: Interventional

Clinical Trial Summary

This is a monocenter randomized controlled trial comparing two systems of mesh and fixation device for the laparoscopic ventral and incisional hernia repair with respect to pain. It has been designed as a superiority study to proof the concept of previously published mathematical model of front abdominal wall.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed Consent Form (ICF) signed by the patient or his/her legal representative

• primary or secondary ventral hernia less than 20 cm in length and less than 11 cm in width requiring elective surgical repair

• recurrence after former abdominal hernia repair WITH MESH

• recurrence after suture abdominal hernia repair CAN be included

Exclusion Criteria:

• no written informed consent

• patient under 18 years old

• emergency surgery (incarcerated hernia)

• patients with expected life time shorter than one year for example due to generalised malignancy

• BMI exceeding 40.0kg/m²

• contaminated surgical fields

• patients on immunosuppression, steroid therapy, constant pain therapy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Abdominal
• Hernia, Ventral
• Hernia,Ventral

Intervention

Procedure:
• Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device.
Laparoscopic intraperitoneal onlay mesh repair for abdominal wall hernia with the use of specially designed mesh and fixation device systems: Physiomesh (mesh implant) and Securestrap (fixation device)
• Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device.
Laparoscopic intraperitoneal onlay mesh repair for abdominal wall hernia with the use of specially designed mesh and fixation device systems: Ventralight ST (mesh implant) and SofbaFix (fixation device)

Device:
• Ventralight ST implant

• ETHICON PHYSIOMESH®

Locations

Country	Name	City	State
Poland	Ceynowa Hospital	Wejherowo	Pomorskie

Sponsors (1)

Lead Sponsor	Collaborator
Polish Hernia Study Group

Country where clinical trial is conducted

Poland, 

References & Publications (17)

Bansal VK, Misra MC, Kumar S, Rao YK, Singhal P, Goswami A, Guleria S, Arora MK, Chabra A. A prospective randomized study comparing suture mesh fixation versus tacker mesh fixation for laparoscopic repair of incisional and ventral hernias. Surg Endosc. 2011 May;25(5):1431-8. doi: 10.1007/s00464-010-1410-6. Epub 2010 Oct 26. — View Citation

Beldi G, Wagner M, Bruegger LE, Kurmann A, Candinas D. Mesh shrinkage and pain in laparoscopic ventral hernia repair: a randomized clinical trial comparing suture versus tack mesh fixation. Surg Endosc. 2011 Mar;25(3):749-55. doi: 10.1007/s00464-010-1246-0. Epub 2010 Jul 23. — View Citation

Bellows CF, Berger DH. Infiltration of suture sites with local anesthesia for management of pain following laparoscopic ventral hernia repairs: a prospective randomized trial. JSLS. 2006 Jul-Sep;10(3):345-50. — View Citation

Byrd JF, Agee N, Swan RZ, Lau KN, Heath JJ, Mckillop IH, Sindram D, Martinie JB, Iannitti DA. Evaluation of absorbable and permanent mesh fixation devices: adhesion formation and mechanical strength. Hernia. 2011 Oct;15(5):553-8. doi: 10.1007/s10029-011-0826-9. Epub 2011 May 19. — View Citation

Carter SA, Hicks SC, Brahmbhatt R, Liang MK. Recurrence and pseudorecurrence after laparoscopic ventral hernia repair: predictors and patient-focused outcomes. Am Surg. 2014 Feb;80(2):138-48. — View Citation

Chelala E, Debardemaeker Y, Elias B, Charara F, Dessily M, Allé JL. Eighty-five redo surgeries after 733 laparoscopic treatments for ventral and incisional hernia: adhesion and recurrence analysis. Hernia. 2010 Apr;14(2):123-9. doi: 10.1007/s10029-010-0637-4. Epub 2010 Feb 14. — View Citation

Clarke T, Katkhouda N, Mason RJ, Cheng BC, Algra J, Olasky J, Sohn HJ, Moazzez A, Balouch M. Fibrin glue for intraperitoneal laparoscopic mesh fixation: a comparative study in a swine model. Surg Endosc. 2011 Mar;25(3):737-48. doi: 10.1007/s00464-010-1244-2. Epub 2010 Jul 31. — View Citation

Deeken CR, Abdo MS, Frisella MM, Matthews BD. Physicomechanical evaluation of absorbable and nonabsorbable barrier composite meshes for laparoscopic ventral hernia repair. Surg Endosc. 2011 May;25(5):1541-52. doi: 10.1007/s00464-010-1432-0. Epub 2010 Oct 26. — View Citation

Deeken CR, Matthews BD. Ventralight ST and SorbaFix versus Physiomesh and Securestrap in a porcine model. JSLS. 2013 Oct-Dec;17(4):549-59. doi: 10.4293/108680813X13693422520125. — View Citation

Eriksen JR, Bech JI, Linnemann D, Rosenberg J. Laparoscopic intraperitoneal mesh fixation with fibrin sealant (Tisseel) vs. titanium tacks: a randomised controlled experimental study in pigs. Hernia. 2008 Oct;12(5):483-91. doi: 10.1007/s10029-008-0375-z. Epub 2008 May 16. — View Citation

Eriksen JR, Poornoroozy P, Jørgensen LN, Jacobsen B, Friis-Andersen HU, Rosenberg J. Pain, quality of life and recovery after laparoscopic ventral hernia repair. Hernia. 2009 Feb;13(1):13-21. doi: 10.1007/s10029-008-0414-9. Epub 2008 Aug 1. — View Citation

Hanna EM, Voeller GR, Roth JS, Scott JR, Gagne DH, Iannitti DA. Evaluation of ECHO PS Positioning System in a Porcine Model of Simulated Laparoscopic Ventral Hernia Repair. ISRN Surg. 2013 May 23;2013:862549. doi: 10.1155/2013/862549. Print 2013. — View Citation

Liang MK, Clapp M, Li LT, Berger RL, Hicks SC, Awad S. Patient Satisfaction, chronic pain, and functional status following laparoscopic ventral hernia repair. World J Surg. 2013 Mar;37(3):530-7. doi: 10.1007/s00268-012-1873-9. — View Citation

Muysoms FE, Miserez M, Berrevoet F, Campanelli G, Champault GG, Chelala E, Dietz UA, Eker HH, El Nakadi I, Hauters P, Hidalgo Pascual M, Hoeferlin A, Klinge U, Montgomery A, Simmermacher RK, Simons MP, Smietanski M, Sommeling C, Tollens T, Vierendeels T, Kingsnorth A. Classification of primary and incisional abdominal wall hernias. Hernia. 2009 Aug;13(4):407-14. doi: 10.1007/s10029-009-0518-x. Epub 2009 Jun 3. Review. — View Citation

Smietanski M, Bigda J, Iwan K, Kolodziejczyk M, Krajewski J, Smietanska IA, Gumiela P, Bury K, Bielecki S, Sledzinski Z. Assessment of usefulness exhibited by different tacks in laparoscopic ventral hernia repair. Surg Endosc. 2007 Jun;21(6):925-8. Epub 2007 Jan 23. — View Citation

Szymczak C, Lubowiecka I, Tomaszewska A, Smietanski M. Investigation of abdomen surface deformation due to life excitation: implications for implant selection and orientation in laparoscopic ventral hernia repair. Clin Biomech (Bristol, Avon). 2012 Feb;27(2):105-10. doi: 10.1016/j.clinbiomech.2011.08.008. Epub 2011 Sep 15. — View Citation

Wassenaar E, Schoenmaeckers E, Raymakers J, van der Palen J, Rakic S. Mesh-fixation method and pain and quality of life after laparoscopic ventral or incisional hernia repair: a randomized trial of three fixation techniques. Surg Endosc. 2010 Jun;24(6):1296-302. doi: 10.1007/s00464-009-0763-1. Epub 2009 Dec 24. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time of the operation	The duration of the surgical procedure	intraoperative	No
Primary	Pain	Presence of pain 7 days after the surgery.	7 days after the surgery	No
Primary	Pain	Presence of pain 3 months after the surgery.	3 months after the surgery	No
Secondary	Number of Participants with Recurrences	The recurrence rate in one year followup.	up to one year	Yes
Secondary	Number of Participants with complications.	The description and percentage distribution of short and long term complications following surgery.	up to one year	Yes
Secondary	Pain intensity	Intensity of pain measured on a visual analogue scale 7 days after the surgery	7 days after the surgery	No
Secondary	Pain intensity	Intensity of pain measured on a visual analogue scale 30 days after the surgery	30 days after the surgery	No
Secondary	Pain intensity	Intensity of pain measured on a visual analogue scale 3 months after the surgery.	3 months after the surgery	No
Secondary	Pain intensity	Intensity of pain measured on a visual analogue scale 6 months after the surgery.	6 months after the surgery	No