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Comparative Study on Self-adhesive Mesh for Open Inguinal Hernia Repair

Randomized Study of Self Gripping Semi-resorbable Mesh (PROGRIP) With Polypropylene Mesh in Open Inguinal Hernia Repair - the 6 Years Result

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00960011
Enrollment
58
Registered
2009-08-17
Start date
2009-06-30
Completion date
2016-05-31
Last updated
2020-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hernia, Inguinal

Keywords

Inguinal hernia, mesh, progrip

Brief summary

Tension-less mesh repair is the most common procedure for inguinal hernia. Conventional heavy weight polypropylene meshes have been reported to stimulate inflammatory reaction and this is responsible for mesh shrinkage and postoperative chronic groin pain. Moreover, the fixation of the mesh with sutures is a tedious procedure and accounts for the majority of the operating time. A self gripping semi-absorbable mesh has been developed for anterior tension free inguinal hernia repair. It has the benefit of light weight property and does not require sutures for fixation. This study aims to compare the outcome of this self-gripping light weight mesh with the conventional heavy weight polypropylene mesh in inguinal hernia repair.

Detailed description

Tension free mesh repair is the most common procedure for inguinal hernia repair. Conventional heavy weight polypropylene meshes have been reported to stimulate inflammatory reaction and this is responsible for mesh shrinkage when scar tissues are formed. In addition, the mesh requires fixation with sutures and there has been postulation that the fixation technique is related to postoperative chronic groin pain. Therefore, some authors have recommended the use of light-weight meshes and to limit the extent of fixation or to use non-compressive absorbable devices. In order to reduce the complications, a new self-gripping semi-resorbable mesh has been developed for anterior tension-free inguinal hernia repair. The aim of this study is to compare the difference in operating time for open inguinal hernia repair with conventional prolene mesh and ProgripTM, which is a light-weight mesh with self-adhesive mechanism. Methodology: Patients present with first episode of inguinal hernia are included into the study. Those with a sizable defect (\>3cm defect), bilateral, inguino-scrotal hernia, irreducible, recurrence are excluded from study. Informed consents are signed before procedures and details of randomization are explained. Operations are performed by or under the supervision of specialist surgeons. Standardized inguinal dissection are performed. Randomization is carried out immediately before placement of mesh and after adequate inguinal dissection. PI / co-investigator phone to research assistant and ask for randomization result generated by computer. Total operative time, time from mesh placement to wound closure, blood loss, intra-operative complications, hospital stay, post-operative pain and analgesic used are documented. Post-operative follow-up: Follow-up on day 14, 3 months, 6 months and 1 year post-op. Pain score, paraesthesia , chronic discomfort / pain, recurrence, seroma formation, testicular atrophy are documented. Thereafter, yearly follow-up is performed at clinic or by telephone to document the recurrence and chronic pain. Parietene ProGrip™ (PP1208DR/ PP1208DL) Manufacturer: Sofradim Production Material: Monofilaments of polypropylene and polylactic acid (PLA) Color: Clear (undyed) Weight: 80g/m2 (before PLA resorbtion), 40g/m2 (after PLA resorbtion) Poresize: 1.7mm x 1mm Material detailed description: Parietene ProGrip™ is the first bio-component mesh comprised of monofilament polyester and a resorbable polylactic acid (PLA) gripping system which perfects true tension-free repair. The microhools cover the entire underside of the material allow complete anchoring of the mesh on the tissue. Self-gripping features also allows a strong and solid self-anchoring fixation and therefore making the hernia sac to fit perfectly to groin anatomy and move less underneath the prosthesis. Therefore, less suture is required and so operative time can be saved. Also less chance of nerve entrapment may cause low postoperative pain. Surgipro Mesh (SPMM-35) Material: Monofilaments of polypropylene Color: Clear (undyed) Measurement: 15cmx15cm Thickness: 0.57mm Description: SURGIPRO Mesh is a non-absorbable, inert, sterile, porous surgical mesh knitted from mono-filament fibers of polypropylene polymer. The mesh exhibits high burst strength and tensile strength. The mesh is knitted in such fashion as to interconnect each mono-filament fiber and provide bi-dimensional elasticity while allowing the mesh to be cut to shape without unraveling. Actions: SURGIPRO Mesh is a porous, non-absorbable mesh used to repair or reinforce fascial defects following surgery or trauma and serves to provide additional support to such wounds during and following the wound healing period. Animal studies have shown that the polypropylene mono-filament fibers from which SURGIPRO Mesh is manufactured elicit a minimal acute inflammatory reaction in tissue, which is then followed by gradual encapsulation by fibrous tissue. In-growth of this fibrous tissue is permitted by the porosity of the knitted mesh structure. The mesh remains soft and pliable and the non-absorbable polypropylene fibers comprising the mesh resists loss of tensile strength in vivo.

Interventions

DEVICEPROGRIP

Use of PROGRIP mesh for open inguinal hernia repair

Use of Polypropylene mesh in open inguinal hernia repair

Sponsors

Queen Mary Hospital, Hong Kong
CollaboratorOTHER
Tung Wah Hospital
CollaboratorOTHER
The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Age above 18 and below 80 * Male or female patients * Unilateral inguinal hernia * First occurrence hernia

Exclusion criteria

* Inguino-scrotal hernia * Recurrent inguinal hernia * Incarcerated hernia * Bilateral inguinal hernia

Design outcomes

Primary

MeasureTime frameDescription
Operating Time From Skin Incision to Wound ClosureIntra-operative recordIt measures the total operating time of 2 groups, measured from time started the skin incision to time finishing wound closure in terms of minutes.

Secondary

MeasureTime frameDescription
Mesh Placement Time, Total Operative TimeIntra-operative recordTime from mesh place to end of operation, and total time of operation
Seroma Formation at First Follow-up1 week after operationSeroma formation at first follow-up, go by clinical
Overall Recurrence at 6 Years6 years after operationOverall recurrence at 6 years, including all recurrence
Chronic Pain at 6 Years6 years after operationPatient with persistent chronic pain sensation at 6 years after operation. It described as painful sensation feeling around the operated site which is persistent and causing disturbance to daily normal life and attracted patients' attention.
Patient With Testicular Atrophy From Post-op to 6 Years After Operation6 years after operationsPatient with testicular atrophy from post-op to 6 years after operation, by clinical examination
Patient With Palpable Mesh at 6 Years After Operation6 years after operationPatient with clinical palpable mesh at 6 years after operation
Patient With Chronic Discomfort at 6 Years After Operation6 years after operationPatient with persistent chronic discomfort at 6 years after operation. It described as an unpleasant feeling around the operated site which is persistent and causing disturbance to daily normal life and attracted patients' attention. It is differentiate from pain sensation.
Pain or Discomfort Affecting Daily Activities at 6 Years After Operation6 years after operationpain or discomfort which affecting daily activities at 6 years after operation
Number of Participants Whose Response Was YES is Reported1 week after operationPatient will be asked by assessor in out-patient clinic about satisfaction about the whole arrangement of operation. We did not intend to grade the satisfaction but simply ask whether they are satisfied. Will be either YES or NO answer.
Wound Pain at Rest at 1 Week After Operation1 week after operationVisual Analogue Score for measurement of wound pain at rest 1 week after operation
Wound Pain on Coughing at 1 Week After Operation1 week after operationwound pain on coughingt at 1 week after operation (Visual Analogue Score). It was in the form of 0-10 where 0 is no pain and 10 is maximal pain they experienced in their life. The higher the value, the more painful it is.
Post-operative Stay1 week after operationPost-operative stay (number of hours)
Days go Outdoor1 week after operationPost-op number of days that patient can go outdoor
Size of Mesh (Longitudinal)intra-operative recordLongitudinal size of mesh (in mm).
Size of Mesh (Vertical)intra-operative recordVertical size of mesh (in mm).
Wound Sizeintra-operative recordSize of main wound
Total Number of Analgesic Used1 week after operationTotal Number of Analgesic Used: Tablets

Countries

China

Participant flow

Participants by arm

ArmCount
PROGRIP
Use of PROGRIP mesh for open inguinal hernia repair PROGRIP: Use of PROGRIP mesh for open inguinal hernia repair
22
POLYPROPYLENE
Use of Polypropylene mesh for open inguinal hernia repair POLYPROPYLENE: Use of Polypropylene mesh in open inguinal hernia repair
23
Total45

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath50
Overall StudyLost to Follow-up62

Baseline characteristics

CharacteristicPOLYPROPYLENEPROGRIPTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
12 Participants12 Participants24 Participants
Age, Categorical
Between 18 and 65 years
11 Participants10 Participants21 Participants
Age, Continuous62.6 years
STANDARD_DEVIATION 16
62.0 years
STANDARD_DEVIATION 15.7
62.3 years
STANDARD_DEVIATION 15.7
Region of Enrollment
Hong Kong
23 participants22 participants45 participants
Sex: Female, Male
Female
1 Participants4 Participants5 Participants
Sex: Female, Male
Male
22 Participants18 Participants40 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 220 / 23
serious
Total, serious adverse events
5 / 220 / 23

Outcome results

Primary

Operating Time From Skin Incision to Wound Closure

It measures the total operating time of 2 groups, measured from time started the skin incision to time finishing wound closure in terms of minutes.

Time frame: Intra-operative record

ArmMeasureValue (MEAN)Dispersion
PROGRIP(PG)Operating Time From Skin Incision to Wound Closure39.2 minutesStandard Deviation 9.8
POLYPROPYLENE(PL)Operating Time From Skin Incision to Wound Closure47.7 minutesStandard Deviation 7.6
Secondary

Chronic Pain at 6 Years

Patient with persistent chronic pain sensation at 6 years after operation. It described as painful sensation feeling around the operated site which is persistent and causing disturbance to daily normal life and attracted patients' attention.

Time frame: 6 years after operation

ArmMeasureValue (NUMBER)
PROGRIP(PG)Chronic Pain at 6 Years3 participants
POLYPROPYLENE(PL)Chronic Pain at 6 Years3 participants
Secondary

Days go Outdoor

Post-op number of days that patient can go outdoor

Time frame: 1 week after operation

ArmMeasureValue (MEAN)Dispersion
PROGRIP(PG)Days go Outdoor2.5 daysStandard Deviation 1.8
POLYPROPYLENE(PL)Days go Outdoor3.7 daysStandard Deviation 2.7
Secondary

Mesh Placement Time, Total Operative Time

Time from mesh place to end of operation, and total time of operation

Time frame: Intra-operative record

ArmMeasureGroupValue (MEAN)
PROGRIP(PG)Mesh Placement Time, Total Operative TimeTotal Operative time47.7 Minutes
PROGRIP(PG)Mesh Placement Time, Total Operative TimeMesh placement time21 Minutes
POLYPROPYLENE(PL)Mesh Placement Time, Total Operative TimeTotal Operative time39.2 Minutes
POLYPROPYLENE(PL)Mesh Placement Time, Total Operative TimeMesh placement time11.8 Minutes
Secondary

Number of Participants Whose Response Was YES is Reported

Patient will be asked by assessor in out-patient clinic about satisfaction about the whole arrangement of operation. We did not intend to grade the satisfaction but simply ask whether they are satisfied. Will be either YES or NO answer.

Time frame: 1 week after operation

ArmMeasureValue (NUMBER)
PROGRIP(PG)Number of Participants Whose Response Was YES is Reported20 participants
POLYPROPYLENE(PL)Number of Participants Whose Response Was YES is Reported23 participants
Secondary

Overall Recurrence at 6 Years

Overall recurrence at 6 years, including all recurrence

Time frame: 6 years after operation

ArmMeasureValue (NUMBER)
PROGRIP(PG)Overall Recurrence at 6 Years0 participants
POLYPROPYLENE(PL)Overall Recurrence at 6 Years1 participants
Secondary

Pain or Discomfort Affecting Daily Activities at 6 Years After Operation

pain or discomfort which affecting daily activities at 6 years after operation

Time frame: 6 years after operation

ArmMeasureValue (NUMBER)
PROGRIP(PG)Pain or Discomfort Affecting Daily Activities at 6 Years After Operation1 participants
POLYPROPYLENE(PL)Pain or Discomfort Affecting Daily Activities at 6 Years After Operation0 participants
Secondary

Patient With Chronic Discomfort at 6 Years After Operation

Patient with persistent chronic discomfort at 6 years after operation. It described as an unpleasant feeling around the operated site which is persistent and causing disturbance to daily normal life and attracted patients' attention. It is differentiate from pain sensation.

Time frame: 6 years after operation

ArmMeasureValue (NUMBER)
PROGRIP(PG)Patient With Chronic Discomfort at 6 Years After Operation1 participants
POLYPROPYLENE(PL)Patient With Chronic Discomfort at 6 Years After Operation1 participants
Secondary

Patient With Palpable Mesh at 6 Years After Operation

Patient with clinical palpable mesh at 6 years after operation

Time frame: 6 years after operation

ArmMeasureValue (NUMBER)
PROGRIP(PG)Patient With Palpable Mesh at 6 Years After Operation1 participants
POLYPROPYLENE(PL)Patient With Palpable Mesh at 6 Years After Operation3 participants
Secondary

Patient With Testicular Atrophy From Post-op to 6 Years After Operation

Patient with testicular atrophy from post-op to 6 years after operation, by clinical examination

Time frame: 6 years after operations

ArmMeasureValue (NUMBER)
PROGRIP(PG)Patient With Testicular Atrophy From Post-op to 6 Years After Operation1 participants
POLYPROPYLENE(PL)Patient With Testicular Atrophy From Post-op to 6 Years After Operation2 participants
Secondary

Post-operative Stay

Post-operative stay (number of hours)

Time frame: 1 week after operation

ArmMeasureValue (MEAN)Dispersion
PROGRIP(PG)Post-operative Stay41.2 hoursStandard Deviation 40.5
POLYPROPYLENE(PL)Post-operative Stay28.6 hoursStandard Deviation 17.2
Secondary

Seroma Formation at First Follow-up

Seroma formation at first follow-up, go by clinical

Time frame: 1 week after operation

ArmMeasureValue (NUMBER)
PROGRIP(PG)Seroma Formation at First Follow-up5 number of patient with seroma at 1 week
POLYPROPYLENE(PL)Seroma Formation at First Follow-up8 number of patient with seroma at 1 week
Secondary

Size of Mesh (Longitudinal)

Longitudinal size of mesh (in mm).

Time frame: intra-operative record

ArmMeasureValue (MEAN)Dispersion
PROGRIP(PG)Size of Mesh (Longitudinal)110.7 mmStandard Deviation 7
POLYPROPYLENE(PL)Size of Mesh (Longitudinal)106.7 mmStandard Deviation 8.2
Secondary

Size of Mesh (Vertical)

Vertical size of mesh (in mm).

Time frame: intra-operative record

ArmMeasureValue (MEAN)Dispersion
PROGRIP(PG)Size of Mesh (Vertical)72 mmStandard Deviation 6.7
POLYPROPYLENE(PL)Size of Mesh (Vertical)66.7 mmStandard Deviation 10
Secondary

Total Number of Analgesic Used

Total Number of Analgesic Used: Tablets

Time frame: 1 week after operation

ArmMeasureValue (MEAN)Dispersion
PROGRIP(PG)Total Number of Analgesic Used10.4 TabletsStandard Deviation 9.1
POLYPROPYLENE(PL)Total Number of Analgesic Used6.7 TabletsStandard Deviation 8.2
Secondary

Wound Pain at Rest at 1 Week After Operation

Visual Analogue Score for measurement of wound pain at rest 1 week after operation

Time frame: 1 week after operation

ArmMeasureValue (MEAN)Dispersion
PROGRIP(PG)Wound Pain at Rest at 1 Week After Operation0.18 score on a scaleStandard Deviation 0.39
POLYPROPYLENE(PL)Wound Pain at Rest at 1 Week After Operation0.13 score on a scaleStandard Deviation 0.34
Secondary

Wound Pain on Coughing at 1 Week After Operation

wound pain on coughingt at 1 week after operation (Visual Analogue Score). It was in the form of 0-10 where 0 is no pain and 10 is maximal pain they experienced in their life. The higher the value, the more painful it is.

Time frame: 1 week after operation

ArmMeasureValue (MEAN)Dispersion
PROGRIP(PG)Wound Pain on Coughing at 1 Week After Operation0.81 score on a scaleStandard Deviation 0.5
POLYPROPYLENE(PL)Wound Pain on Coughing at 1 Week After Operation0.83 score on a scaleStandard Deviation 0.49
Secondary

Wound Size

Size of main wound

Time frame: intra-operative record

ArmMeasureValue (MEAN)Dispersion
PROGRIP(PG)Wound Size50.7 mmStandard Deviation 7.1
POLYPROPYLENE(PL)Wound Size53.5 mmStandard Deviation 5.7

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026