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

NCT02233569 | Terminated DMC

• 1 other identifier: PHvsVS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hernia, Abdominal; Hernia,Ventral

Keywords

Laparoscopic hernia repair; Ventral hernia; Incisional hernia; IPOM

Outcome Measures

Primary Outcomes (2)

• Pain

  Presence of pain 7 days after the surgery.

  7 days after the surgery

• Pain

  Presence of pain 3 months after the surgery.

  3 months after the surgery

Secondary Outcomes (6)

• Number of Participants with Recurrences

  up to one year

• Number of Participants with complications.

  up to one year

• Pain intensity

  7 days after the surgery

• Pain intensity

  30 days after the surgery

• Pain intensity

  3 months after the surgery

Other Outcomes (1)

• Time of the operation

  intraoperative

Study Arms (2)

PH

ACTIVE COMPARATOR

Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device.

Procedure: Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device.; Device: ETHICON PHYSIOMESH®

VS

ACTIVE COMPARATOR

Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device.

Procedure: Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device.; Device: Ventralight ST implant

Interventions

Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device. PROCEDURE

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)

Also known as: ETHICON PHYSIOMESH® Flexible Composite Mesh, ETHICON SECURESTRAP® Fixation Device

PH

Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device. PROCEDURE

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)

Also known as: BARD DAVOL INC., VENTRALIGHT™ ST Mesh, Proven Sepra® Technology in a Low Profile, Lightweight Mesh, ECHO PS™ Positioning System, SORBAFIX™Absorbable Fixation System

VS

Ventralight ST implant DEVICE

VS

ETHICON PHYSIOMESH® DEVICE

PH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Polish Hernia Study Group: lead

Study Sites (1)

Ceynowa Hospital

Wejherowo, Pomeranian Voivodeship, 84-200, Poland

Location

Related 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.

  PMID: 20976495 BACKGROUND

• 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.

  PMID: 20652715 BACKGROUND

• 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.

  PMID: 17212893 BACKGROUND

• 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.

  PMID: 21594698 BACKGROUND

• 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.

  PMID: 24480213 BACKGROUND

• Chelala E, Debardemaeker Y, Elias B, Charara F, Dessily M, Alle 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.

  PMID: 20155431 BACKGROUND

• 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.

  PMID: 20680350 BACKGROUND

• 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.

  PMID: 20976479 BACKGROUND

• 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.

  PMID: 24398196 BACKGROUND

• 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.

  PMID: 18483783 BACKGROUND

• Eriksen JR, Poornoroozy P, Jorgensen 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.

  PMID: 18670733 BACKGROUND

• 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.

  PMID: 23762628 BACKGROUND

• 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.

  PMID: 23212794 BACKGROUND

• 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.

  PMID: 19495920 BACKGROUND

• 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. doi: 10.1007/s00464-006-9055-1. Epub 2007 Jan 23.

  PMID: 17242988 BACKGROUND

• 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). 2012 Feb;27(2):105-10. doi: 10.1016/j.clinbiomech.2011.08.008. Epub 2011 Sep 15.

  PMID: 21920647 BACKGROUND

• 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.

  PMID: 20033726 BACKGROUND

MeSH Terms

Conditions

Hernia, Abdominal; Hernia, Ventral; Incisional Hernia

Interventions

Wound Healing

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Regeneration; Biological Phenomena

Study Officials

• Maciej Pawlak, MD

  PRINCIPAL INVESTIGATOR

• Maciej Śmietański, PhD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: September 8, 2014
• Study Start: November 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: September 8, 2014

Record last verified: 2014-09

Locations

PL (1)