Comparison of Two Mesh/Fixation Concepts for Laparoscopic Ventral and Incisional Hernia Repair
Primary Purpose
Hernia, Abdominal, Hernia,Ventral
Status
Terminated
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device.
Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device.
Ventralight ST implant
ETHICON PHYSIOMESH®
Sponsored by
About this trial
This is an interventional treatment trial for Hernia, Abdominal focused on measuring Laparoscopic hernia repair, Ventral hernia, Incisional hernia, IPOM
Eligibility Criteria
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
Sites / Locations
- Ceynowa Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
PH
VS
Arm Description
Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device.
Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device.
Outcomes
Primary Outcome Measures
Pain
Presence of pain 7 days after the surgery.
Pain
Presence of pain 3 months after the surgery.
Secondary Outcome Measures
Number of Participants with Recurrences
The recurrence rate in one year followup.
Number of Participants with complications.
The description and percentage distribution of short and long term complications following surgery.
Pain intensity
Intensity of pain measured on a visual analogue scale 7 days after the surgery
Pain intensity
Intensity of pain measured on a visual analogue scale 30 days after the surgery
Pain intensity
Intensity of pain measured on a visual analogue scale 3 months after the surgery.
Pain intensity
Intensity of pain measured on a visual analogue scale 6 months after the surgery.
Full Information
NCT ID
NCT02233569
First Posted
August 29, 2014
Last Updated
September 5, 2014
Sponsor
Polish Hernia Study Group
1. Study Identification
Unique Protocol Identification Number
NCT02233569
Brief Title
Comparison of Two Mesh/Fixation Concepts for Laparoscopic Ventral and Incisional Hernia Repair
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Terminated
Why Stopped
The high recurrence rate and the findings during the reoperations were considered as serious adverse events and were the reason for study termination.
Study Start Date
November 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Polish Hernia Study Group
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Abdominal, Hernia,Ventral
Keywords
Laparoscopic hernia repair, Ventral hernia, Incisional hernia, IPOM
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PH
Arm Type
Active Comparator
Arm Description
Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device.
Arm Title
VS
Arm Type
Active Comparator
Arm Description
Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device.
Intervention Type
Procedure
Intervention Name(s)
Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device.
Other Intervention Name(s)
ETHICON PHYSIOMESH® Flexible Composite Mesh, ETHICON SECURESTRAP® Fixation Device
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device.
Other Intervention Name(s)
BARD DAVOL INC., VENTRALIGHT™ ST Mesh, Proven Sepra® Technology in a Low Profile, Lightweight Mesh, ECHO PS™ Positioning System, SORBAFIX™Absorbable Fixation System
Intervention Description
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)
Intervention Type
Device
Intervention Name(s)
Ventralight ST implant
Intervention Type
Device
Intervention Name(s)
ETHICON PHYSIOMESH®
Primary Outcome Measure Information:
Title
Pain
Description
Presence of pain 7 days after the surgery.
Time Frame
7 days after the surgery
Title
Pain
Description
Presence of pain 3 months after the surgery.
Time Frame
3 months after the surgery
Secondary Outcome Measure Information:
Title
Number of Participants with Recurrences
Description
The recurrence rate in one year followup.
Time Frame
up to one year
Title
Number of Participants with complications.
Description
The description and percentage distribution of short and long term complications following surgery.
Time Frame
up to one year
Title
Pain intensity
Description
Intensity of pain measured on a visual analogue scale 7 days after the surgery
Time Frame
7 days after the surgery
Title
Pain intensity
Description
Intensity of pain measured on a visual analogue scale 30 days after the surgery
Time Frame
30 days after the surgery
Title
Pain intensity
Description
Intensity of pain measured on a visual analogue scale 3 months after the surgery.
Time Frame
3 months after the surgery
Title
Pain intensity
Description
Intensity of pain measured on a visual analogue scale 6 months after the surgery.
Time Frame
6 months after the surgery
Other Pre-specified Outcome Measures:
Title
Time of the operation
Description
The duration of the surgical procedure
Time Frame
intraoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maciej Pawlak, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maciej Śmietański, PhD
Official's Role
Study Director
Facility Information:
Facility Name
Ceynowa Hospital
City
Wejherowo
State/Province
Pomorskie
ZIP/Postal Code
84-200
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
20976495
Citation
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.
Results Reference
background
PubMed Identifier
20652715
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.
Results Reference
background
PubMed Identifier
17212893
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.
Results Reference
background
PubMed Identifier
21594698
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.
Results Reference
background
PubMed Identifier
24480213
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.
Results Reference
background
PubMed Identifier
20155431
Citation
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.
Results Reference
background
PubMed Identifier
20680350
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.
Results Reference
background
PubMed Identifier
20976479
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.
Results Reference
background
PubMed Identifier
24398196
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.
Results Reference
background
PubMed Identifier
18483783
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.
Results Reference
background
PubMed Identifier
18670733
Citation
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.
Results Reference
background
PubMed Identifier
23762628
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.
Results Reference
background
PubMed Identifier
23212794
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.
Results Reference
background
PubMed Identifier
19495920
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.
Results Reference
background
PubMed Identifier
17242988
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. doi: 10.1007/s00464-006-9055-1. Epub 2007 Jan 23.
Results Reference
background
PubMed Identifier
21920647
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.
Results Reference
background
PubMed Identifier
20033726
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.
Results Reference
background
Learn more about this trial
Comparison of Two Mesh/Fixation Concepts for Laparoscopic Ventral and Incisional Hernia Repair
We'll reach out to this number within 24 hrs