The objective of the International Hernia Mesh Registry is to observe a minimum of 3,500 patients for up to 2 years post implantation, in a post-market setting, following the use of either ETHICON Mesh Products or other marketed mesh products to…
ID
Source
Brief title
Condition
- Soft tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The co-primary effectiveness variables are to evaluate the outcomes of the
hernia procedure defined as:
• Recurrence of the hernia
• Pain assessment scores provided by patients for the duration of the registry:
o Acute Pain
o Chronic Pain
Secondary outcome
The secondary effectiveness variables include post-operative evaluations
reported by the patients over the two year follow-up, utilizing web-based,
telephoned-based and/or mail systems. These variables will be used to collect
and assess data on each Mesh Product Group.
There will also be information supplied by each surgeon on ETHICON light weight
products handling and duration of operation.
The secondary effectiveness variables will include:
• Assessments of intra-operative handling characteristics for each light weight
ETHICON mesh product.
• Post-operative complications:
o Surgical Site Infection;
- Superficial SSI
- Deep SSI
o Seroma formation
o Hematoma
o Inflammation
o Fistula formation
o Extrusion
o Other device and implantation related adverse events
• Device and implantation procedure related adverse events after the scheduled
the Day of Implantation.
• Operating room time (defined as the time elapsed from first incision to
closure (suture, staples, etc.)
Background summary
Prosthetic mesh has been used for more than 25 years in the repair of hernia
defects (2). A variety of prosthetic materials have been used for abdominal
wall replacement with varying results. Complications of synthetic materials
have been largely related to the intrinsic tendency of the materials to promote
inflammation or serve as a nidus for infection (3).
Despite the advantages and the importance of alloplastic materials, there are a
number of theoretical disadvantages arising from mesh use:
• The incorporation of a mass of biomaterial may promote the development of
seromas
• The physiological wound healing process induces mesh contraction to some
degree, depending on the mesh structure and the corresponding inflammation
• Concomitant scar plates can reduce abdominal wall mobility
• Meshes can migrate and produce persistent inflammation, while explanted
meshes can appear bunched, shrunken and folded
• Mesh products have been associated with potentiation of infection, adhesion
formation, fistula formation, extrusion and foreign body reaction.
Heavier weight meshes tend to have greater site response due to foreign body
reaction. Studies in various animals have shown that the foreign body reaction
is lower with lightweight meshes. The biocompatibility of the mesh is improved
by a larger pore construction (4).
When operating in contaminated or potentially contaminated fields, such as
incarcerated hernias, colorectal surgeries, or incisional hernias in high risk,
i.e., highly obese, diabetic or immune-compromised patients, surgeons are
reluctant to use permanent materials. This is due to a higher risk for deep
mesh infection with the potential of possible bacterial biofilm formation that
can occur on permanent material. The literature suggests biologic implants,
consisting of animal (small intestine submucosa (SIS) of pigs) or human derived
collagen, are frequently used in these situations since they may have less
affinity to bacterial attachment, allow for better tissue in-growth and
vascularization and induce less postoperative complications because no
permanent material remains. Biologic materials show some promising short-term
results but they can also lead to complications like seroma formation, high
recurrence rates and even infection. Since these meshes fail to provide
permanent support, their long-term efficacy is still unknown (5).
(2) Usher FC: *New technique for repairing incisional hernias with Marlex mesh*
Am J Surg. 1979; 138; 740-41.
(3) Bauer JJ, Salky BA, Gelernt IM, Kreel I. Repair of Large Abdominal wall
defects with expanded polytetrafluorethylene (PFTE). Annals of Surgery 1987;
206:6 765-769.
(4) Cobb WS, Kercher KW, Heniford, BT The Argument for Lightweight
Polypropylene Mesh in Hernia Repair. Surg Innovations 2005, 12:1. T1-T7.
(5) Mesh for Contaminate Area (MCA) The treatment of hernias in challenging
surgical situations - literature review-Internal ETHICON, Inc. document
2007-2009.
Study objective
The objective of the International Hernia Mesh Registry is to observe a minimum
of 3,500 patients for up to 2 years post implantation, in a post-market
setting, following the use of either ETHICON Mesh Products or other marketed
mesh products to help identify best practices leading to lower recurrence rates
and decreases in chronic pain, associated with the hernia repair procedure.
Study design
This is an open-label, multi-center, long-term, prospective hernia mesh
registry. A minimum of 3,500 hernia patients will be enrolled at approximately
30-60 sites globally.
Prior to implantation, investigators will seek participation from patients
interested in providing long-term, post-surgical, outcomes data for the
International Hernia Mesh Registry. Investigators will sequentially enroll
patients using any mesh product for hernia repair.
Patients will be enrolled into the registry into one of four Mesh Product
Groups:
o Flat Mesh Group
- ULTRAPRO Mesh or other flat mesh for the same type of hernia procedure
o Tissue Separating Flat Mesh Group
- PROCEED Surgical Mesh or a comparable tissue separating mesh for the same
type of hernia procedure.
- ETHICON PHYSIOMESHTM or a comparable tissue separating mesh for the same type
of hernia procedure
* Tissue Separating Device Group
- PROCEED Ventral Patch or other tissue separating mesh devices for the same
type of hernia procedure.
* Non-Tissue Separating Device Group
- ULTRAPRO Hernia System or other mesh device for the same type of hernia
procedure.
- ULTRAPRO Plug or other mesh plug device for the same type of hernia
procedure.
For each of the selected light weight ETHICON meshes a separate handling
characteristic assessment will be completed by each surgeon for their first 5
operations using that mesh.
Patients will be asked to provide internet, mail, or telephone responses
post-implantation at approximately Month 1, 6 and Years 1 and 2.. During each
contact the patient will be asked to complete a follow up questionnaire, which
encompasses any surgically-related issues and CCS which includes a pain
assessment. Patients will be contacted by Outcome Sciences, utilizing the
patient*s preferred method of contact if their responses have not been
received. Outcome staff may complete the questionnaire during the telephone
conversation with the patient.
If Outcome Sciences obtains questionnaire information by phone contact where a
patient reports a recurrence of their hernia or disabling symptoms on the CCS,
they will ask the patient to schedule a follow up visit for review of their
symptoms with the original registry surgeon.
If a patient has a re-operation for a recurrence of the hernia for which he/she
was entered into the registry, that patient should be discontinued by the
surgeon.
Study burden and risks
Participants will receive standard of care for their hernia repair surgery.
The risks associated with participating in the Registry are the same as with
any surgical procedure. The Registry does not deviate from normal standard of
care at the investigator site.
As specified in the Patient Information Sheet:
"We do not anticipate there to be any side effects or risks linked to
participation in the Registry. We will only collate information about how
successful your operation was and how long you will be able to enjoy its
benefits. During the study you will be able to contact your surgeon at any time
to discuss any concerns you may have.
As with any surgical procedure, there are a number of risks associated with the
operation. Your surgeon will already have discussed these with you before you
made your decision to undergo the operation, but you may ask him to explain
these once again if you wish."
Simpson Parkway, Kirkton Campus Livingston
Scotland EH54 7AT
GB
Simpson Parkway, Kirkton Campus Livingston
Scotland EH54 7AT
GB
Listed location countries
Age
Inclusion criteria
4.1. Inclusion Criteria
Patients must satisfy the following criteria before entering the registry:
1. Provide written informed consent;
2. Male or female patients that are > 18 years of age;
3. Be literate and able to understand a language available in the Registry Patient Questionnaires;
4. Be scheduled to receive a surgically implanted mesh product for repair of a hernia defect;
5. Agree to provide long-term, outcomes data to Outcome Sciences;
6. Agree to provide contact information.
Exclusion criteria
4.2. Exclusion Criteria
Patients who meet any of the following criteria will be excluded from participating in the registry:
1. Patients that are <18 years of age;
2. Patients who have been entered into the registry previously;
3. Employees of the investigator or registry center with direct involvement in the proposed registry or other studies under the direction of that investigator or registry center and employees of ETHICON;
4. Patients suffering from and currently receiving medication for chronic pain;
5. Patients known to be suffering from pre-existing chronic depression;
6. Patients currently known or suspected to abuse drugs or alcohol;
7. Patients suffering from a terminal illness (e.g. cancer);
8. Patients requiring multiple hernia repairs utilizing more than one mesh or device (except bilateral femoral, if operated on the same day). Two or more pieces of the same mesh product sewn together will be considered as one mesh, and is therefore allowed in this registry;
9. Patients requiring any other (concomitant) surgical procedure;
10. Patients suffering from an ongoing infection, sepsis, contaminated mesh or fistulas;
11. Patients who require inguinal hernia repair.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT00622583 |
| CCMO | NL41515.028.12 |