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The purpose of this study is to evaluate the safety and performance of the 4DMESH® used in (robot-assisted) laparoscopic inguinal and femoral hernia repair. The goal of the study will be achieved by assessing the prevalence of recurrences, pain, quality-of-life (QoL), return to daily activities and work and groin symptoms, and by reporting of peri- and postoperative complications in a prospectively maintained database.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-shaped 4DMESH® | Device | The 4DMESH® mesh is semi-resorbable parietal reinforcement implant made of 25% Polypropylene (non-resorbable) and 75% Poly-L-Lactic Acid (resorbable). 4DMESH® meshes are designed for the repair and reinforcement of inguinal and femoral hernias. 4DMesh is a CE-marked, class III medical device manufactured by Cousin Biotech. |
| Measure | Description | Time Frame |
|---|---|---|
| Hernia recurrence | To determine the prevalence of hernia recurrence at 12-months follow-up via an abdominal ultrasound during an in-hospital visit. | At 12-months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | To determine the percentage of procedures with technical success, defined as (robot-assisted) laparoscopic TEP or TAPP as intended without technical difficulties and without conversion to open laparotomy. | At index-procedure |
| Duration of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg Genk | Genk | Limburg | 3600 | Belgium | ||
| Regionaal Ziekenhuis Heilig Hart Tienen |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| D006550 | Hernia, Femoral |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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To determine the mean duration of the surgery. |
| At index-procedure |
| Duration of hospital stay | To determine the mean duration of hospital stay. | At the moment the patient is discharged from the hospital after the procedure (discharge), an average of 1 day |
| Peri- and post-operative complications related to 4DMESH® | To determine the rate of peri- and post-operative complications related to 4DMESH® up to 5-years follow-up. | At 5-years follow-up |
| Early recurrences | To determine the early recurrence rate at 4-5 weeks follow-up. | At 4-5 weeks follow-up |
| Late recurrence rate | To determine the recurrence rate at 24-months follow-up (Patient Reported Outcome Measure (PROM) via telephone call). | At 24-months follow-up |
| Late recurrence rate | To determine the recurrence rate at 60-months follow-up (Patient Reported Outcome Measure (PROM) via telephone call). | At 60-months follow-up |
| Mesh migration and mesh shrinkage | To evaluate the incidence of mesh migration and mesh shrinkage at 12-months follow-up via abdominal ultrasound (only in specialized investigational centers ). | At 12-months follow-up |
| Re-intervention | To determine the incidence of hernia surgery related re-interventions since the (robot-assisted) laparoscopic TEP or TAPP procedure. | At 5-years follow-up |
| Explantation rate | To determine the explantation rate since the (robot-assisted) laparoscopic TEP or TAPP procedure. | At 5-years follow-up |
| Return to daily activities | To determine the mean number of days when the patient returned to daily activities after the operation, assessed at 4-5 weeks follow-up. | At 4-5 weeks follow-up |
| Return to work | To determine the mean number of days when the patient returned to work after the operation, assessed at 4-5 weeks follow-up. | At 4-5 weeks follow-up |
| Pre-operative pain scoring | To determine pain (at rest, normal activity, strenuous activity) assessed using the McCarthy visual analogue scale (0-150 mm, higher score means more pain). | At baseline |
| Post-operative pain scoring | To determine pain (at rest, normal activity, strenuous activity) assessed using the McCarthy visual analogue scale (0-150 mm, higher score means more pain). | At discharge, an average of 1 day |
| Post-operative pain scoring | To determine pain (at rest, normal activity, strenuous activity) assessed using the McCarthy visual analogue scale (0-150 mm, higher score means more pain). | At 4-5 weeks follow-up |
| Post-operative pain scoring | To determine pain (at rest, normal activity, strenuous activity) assessed using the McCarthy visual analogue scale (0-150 mm, higher score means more pain). | At 12-months follow-up |
| Post-operative pain scoring | To determine pain (at rest, normal activity, strenuous activity) assessed using the McCarthy visual analogue scale (0-150 mm, higher score means more pain). | At 24-months follow-up |
| Post-operative pain scoring | To determine pain (at rest, normal activity, strenuous activity) assessed using the McCarthy visual analogue scale (0-150 mm, higher score means more pain). | At 60-months follow-up |
| Intake of analgesics | To register intake of analgesics. | At the moment the patient is discharged from the hospital after the procedure (discharge), an average of 1 day |
| Intake of analgesics | To register intake of analgesics. | At 4-5 weeks follow-up |
| Intake of analgesics | To register intake of analgesics. | At 12-months follow-up |
| Intake of analgesics | To register intake of analgesics. | At 24-months follow-up |
| Intake of analgesics | To register intake of analgesics. | At 60-months follow-up |
| QoL | To assess QoL by the EQ-5D questionnaire. | At baseline |
| QoL | To assess QoL by the EQ-5D questionnaire. | At 4-5 weeks follow-up |
| QoL | To assess QoL by the EQ-5D questionnaire. | At 12-months follow-up |
| QoL | To assess QoL by the EQ-5D questionnaire. | At 24-months follow-up |
| QoL | To assess QoL by the EQ-5D questionnaire. | At 60-months follow-up |
| EQ-5D change | To determine EQ-5D change assessed by minimally important differences at baseline and follow-up (outcome: worse, no change, better). | At 4-5 weeks follow-up |
| EQ-5D change | To determine EQ-5D change assessed by minimally important differences at baseline and follow-up (outcome: worse, no change, better). | At 12-months follow-up |
| EQ-5D change | To determine EQ-5D change assessed by minimally important differences at baseline and follow-up (outcome: worse, no change, better). | At 24-months follow-up |
| EQ-5D change | To determine EQ-5D change assessed by minimally important differences at baseline and follow-up (outcome: worse, no change, better). | At 60-months follow-up |
| Subjective groin symptoms | To assess the occurrence of subjective groin symptoms at follow-up (awareness of groin lump, perception of foreign material in groin, loss of skin sensation in groin, discomfort in groin). | At 4-5 weeks follow-up |
| Subjective groin symptoms | To assess the occurrence of subjective groin symptoms at follow-up (awareness of groin lump, perception of foreign material in groin, loss of skin sensation in groin, discomfort in groin). | At 12-months follow-up |
| Subjective groin symptoms | To assess the occurrence of subjective groin symptoms at follow-up (awareness of groin lump, perception of foreign material in groin, loss of skin sensation in groin, discomfort in groin). | At 24-months follow-up |
| Subjective groin symptoms | To assess subjective groin symptoms at follow-up (awareness of groin lump, perception of foreign material in groin, loss of skin sensation in groin, discomfort in groin). | At 60-months follow-up |
| Global groin symptoms | To assess the level of global groin symptoms at follow-up compared to baseline (outcome: worse, no change, better). | At 4-5 weeks follow-up |
| Global groin symptoms | To assess the level of global groin symptoms at follow-up compared to baseline (outcome: worse, no change, better). | At 12-months follow-up |
| Global groin symptoms | To assess the level of global groin symptoms at follow-up compared to baseline (outcome: worse, no change, better). | At 24-months follow-up |
| Global groin symptoms | To assess the level of global groin symptoms at follow-up compared to baseline (outcome: worse, no change, better). | At 60-months follow-up |
| Impact on sex life | To assess the impact on sex life at follow-up compared to baseline (outcome: worse, no change, better). | At 4-5 weeks follow-up |
| Impact on sex life | To assess the impact on sex life at follow-up compared to baseline (outcome: worse, no change, better). | At 12-months follow-up |
| Impact on sex life | To assess the impact on sex life at follow-up compared to baseline (outcome: worse, no change, better). | At 24-months follow-up |
| Impact on sex life | To assess the impact on sex life at follow-up compared to baseline (outcome: worse, no change, better). | At 60-months follow-up |
| Tienen |
| Vlaams-Brabant |
| 3300 |
| Belgium |
| AZ Groeninge | Kortrijk | West-Vlaanderen | 8500 | Belgium |
| Hôpital Lyon Sud, Hospices Civils de Lyon | Lyon | 69002 | France |
| CHU de Nantes | Nantes | 44093 | France |
| CHU de Reims | Reims | 51092 | France |
| CH de Tourcoing | Tourcoing | 59208 | France |
| Hospital Universitario Virgen Macarena | Seville | 41009 | Spain |
| Hospital Viamed Santa Ángela de la Cruz en Sevilla | Seville | 41014 | Spain |