The objective of this study is to collect additional data on the safety and performance of the slowly-resorbable TIGR® mesh in patients undergoing TEP for IGRP.
ID
Source
Brief title
Condition
- Other condition
- Soft tissue therapeutic procedures
Synonym
Health condition
Inguinal-related groin pain, sportershernia
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is pain during exercise on the numeric rating scale
(NRS), where 0 is no pain and 10 is the most extreme pain imaginable. Pain will
be measured during their pre-injury sport and at their pre-injury duration and
intensity.
Secondary outcome
The secondary outcome measures will be the following validated questionnaires
and scores:
- Safety in terms of intra-operative and postoperative complications.
Intra-operatively the feasibility of the product in this setting will be
assessed, the time of implantation of the mesh will be recorded, any problems
encountered by the researcher after each procedure will be asked (feasibility
of TIGR® Matrix (ease and practicality of use). Intraoperative complications
(bleeding, lesion of ductus deference, other) and post-operative complications
will be recorded, including surgical site occurrence (SSO) according to the
Ventral Hernia Working Group (surgical site infection (SSI), seroma, wound
dehiscence, enterocutaneous fistula, wound cellulitis, non-healing incisional
wound, fascial disruption, skin or soft tissue ischemia, skin or soft tissue
necrosis, wound serous or purulent drainage, stitch abscess, seroma, hematoma
and infected or exposed mesh), SSOs requiring a procedural intervention (SSOPI)
defined as wound opening or debridement, suture excision, percutaneous
drainage, or mesh removal.
- Sport resumption (timespan (in weeks) until resuming full level of sport
activity in athletes (in frequency and intensity);
- The rate of CPIP using the validated Inguinal Pain Questionnaire (IPQ v1.0
2008)(37, 38), where a lower score indicates fewer CPIP complaints and a higher
score indicates more CPIP complaints;
- The confidence in return to sport levels according the validated
Injury-Psychological Readiness to Return to Sport (I-PRRS v1.1 October 2018)
scale, in which a low score indicates a low confidence in return to sports and
a high score indicates a high confidence in return to sports (39);
- Symptoms, activity limitations, participation restrictions and quality of
life using the validated Copenhagen Hip and Groin Outcome Score, in which a low
score indicates few symptoms, few acitivity limitations, little participation
restrictions and a high quality of life. A high score indicates many symptoms,
many activity limitations, many participation restrictions and a low quality of
life (HAGOS v1.0 August 2013) (40, 41);
- Recurrences of inguinal-related groin pain.
Background summary
Groin pain is a common complaint among high-performance athletes. The estimated
occurrence of groin pain in athletes is 5% to 28% and is most seen in hockey
and soccer players, but can also be seen in non-athletes. In some cases there
is no clear pathology that causes this groin pain. In these cases,
inguinal-related groin pain might be present. Inguinal-related groin pain
presents with acute or chronic groin pain to the lower abdominal muscles, pubic
symphysis and adductor musculature which is caused by and exacerbated with
vigorous sport or physical activity.
After other causes of groin pain are excluded by history taking, physical
examination and medical imaging, adequate treatment is important for fast
recovery and resumption of sport activities. Conservative options for treatment
of inguinal-related groin pain consist of physical therapy and rehabilitation
programmes. Other non-operative management strategies are plasma enriched
protein and steroid injections. Surgical treatment should be considered when
conservative treatment has failed. Surgical options include endoscopic totally
extraperitoneal (TEP) procedure with mesh. Promising results in fast resumption
of sport activities after TEP procedure for inguinal-related groin pain are
shown in the literature.
The most frequent used method for TEP procedure is with a non-resorbable mesh.
However, the use of a non-resorbable mesh may cause problems concerning mesh
contractures, chronic postoperative inguinal pain (CPIP) and its inability to
grow with the patient. Although in experience hands the risk of these
complications is low, patients with inguinal-related groin pain are relatively
young and this foreign body will remain in place for life. The
slowly-resorbable TIGR® Matrix mesh will stimulate collagen formation, which
will take over the function of the mesh i.e. reinforcement of the abdominal
wall. Therefore, the advantage of resorbable mesh over non-resorbable mesh is
that the amount of foreign material persisting in the host is reduced, avoiding
potential risks associated with a non-resorbable mesh, but without compromising
the biomechanical resistance of the mesh.
We propose a single arm prospective pilot study to evaluate the safety,
effectivity, and feasibility of the slowly-resorbable TIGR® Matrix mesh in
patients presenting with inguinal-related groin pain undergoing TEP procedure.
Based on these results the feasibility and necessity of a superiority or
non-inferiority trial may be determined on estimated prevalence rates. The
results of present study will be exploratory and not conclusive.
Study objective
The objective of this study is to collect additional data on the safety and
performance of the slowly-resorbable TIGR® mesh in patients undergoing TEP for
IGRP.
Study design
A multicenter single arm prospective phase II study
Intervention
TEP procedure for inguinal-related groin pain will be performed. During this
procedure a slowly-resorbable TIGR® Matrix mesh will be implanted instead of a
non-resorbable polypropylene mesh, which is used in current standard practice.
Study burden and risks
Patients/participans with inguinal-related groin pain undergoing TEP procedure
will receive a slowly-resorbable TIGR® Matrix mesh instead of a non-resorbable
mesh.
The potential benefits of this fully resorbable mesh compared to the
non-resorbable meshes are a possible reduced risk of seroma formation,
infection, persistent pain, CPIP and mesh contractures. A higher recurrence
rate may be a potential risk of this product compared to non-resorbable mesh.
During the follow-up, participants will visit the outpatient clinic four times.
During these visits physical investigation will be performed. Also, the
participant will fill in two questionnaires at different times during the
follow-up.
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
- Athletes with inguinal-related groin pain, as defined in the Doha agreement
i.e. *pain location in the inguinal canal region and tenderness of the inguinal
canal*, that was not sufficient resolved with standard conservative treatment
of at least 2 months, undergoing elective TEP procedure.
- Frequency sports activity >2/week.
- Age >= 18 years.
- Signed informed consent by patient.
- Wish to return to pre injury sports.
Exclusion criteria
- Inguinal or femoral hernia on ultrasound imaging.
- Previous inguinal hernia surgery.
- Patient with clearly more complaints due to an adductor-related groin pain
instead of the inguinal-related groin
pain as examined by clinician after 2 months of conservative treatment.
- Existing Chronic Postoperative Inguinal Pain (CPIP).
- Nerve entrapment as assessed by clinician.
- Referred spinal pain.
- Apophysitis or avulsion fracture of pelvic bone in the groin area.
- Disorders to the hip joint or bursitis.
- Intra-abdominal disorders including urologic, gynecologic or bowel pathology.
- Inadequate knowledge of the Dutch language.
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL77449.078.21 |
| Other | NL9386 |