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The objective of this retrospective study is to evaluate the postoperative clinical outcomes at discharge, 1 month and 12 months, associated with the use of Parietex™ ProGrip™ in Laparoscopic Transabdominal preperitoneal inguinal hernia repair. Results from this study will be used to support the short- and long-term clinical outcomes of Parietex™ ProGrip™ when used in inguinal hernia repair by laparoscopic approach.
The primary outcome:
• Proportion of subjects who experience hernia recurrence (defect treated initially with Parietex™ ProGrip™) within 12 months post-surgery.
Recurrence is defined as a clinically manifest bulge or a protrusion exacerbated by a Valsalva maneuver in the operated groin.
The recurrence symptoms are assessed by phone based on the Symptoms Questionnaire and the recurrence diagnosis is confirmed during a physical examination by a physician and defined as a clinically manifest bulge or a protrusion exacerbated by a Valsalva maneuver in the operated groin. If subject has a surgical repair of the hernia within the 12 month postoperative period, it will be documented as evidence of hernia recurrence.
The secondary outcome:
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Who Experience Hernia Recurrence (Defect Treated Initially With Parietex™ ProGrip™) Within 12 Months Post-surgery. | Recurrence is defined as a clinically manifest bulge or a protrusion exacerbated by a Valsalva maneuver in the operated groin. The recurrence symptoms are assessed by phone based on the Symptoms Questionnaire and the recurrence diagnosis is confirmed during a physical examination by a physician. | At least 12 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Groin Pain (Pain Score 0-10) | 12 month post-operatively | |
| Analgesic Use | The day of the discharge (an expected average of 1 day), 1month and at least 12 month post-operatively | |
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Inclusion Criteria:
The following diagnosis will be included:
All subjects must meet the following inclusion criteria:
Exclusion Criteria:
Subjects who meet any of the following exclusion criteria are not eligible for study participation:
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All subjects have undergone Laparoscopic Transabdominal preperitoneal surgical treatment for inguinal hernia repair with Parietex™ ProGrip™ without additional fixation between September 2008 and March 2010 (inclusive) with at least 12 months of follow-up. Subjects must meet the protocol outlined eligibility criteria to be included in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Dieter BIRK, MD | Evangelisches Krankenhaus Zweibrücken - Obere Himmelsbergstr. 38 - 66482 Zweibrücken - GERMANY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evangelisches Krankenhaus Zweibrücken - Obere Himmelsbergstr. 38 | Zweibrücken | 66482 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Parietex Progrip | Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Parietex Progrip | Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Subjects Who Experience Hernia Recurrence (Defect Treated Initially With Parietex™ ProGrip™) Within 12 Months Post-surgery. | Recurrence is defined as a clinically manifest bulge or a protrusion exacerbated by a Valsalva maneuver in the operated groin. The recurrence symptoms are assessed by phone based on the Symptoms Questionnaire and the recurrence diagnosis is confirmed during a physical examination by a physician. | Posted | Number | participants | At least 12 months post-surgery |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Parietex Progrip | Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Docteur Dieter BIRK | Surgical Department of the Protestant Hospital | 06332 422120 |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Postoperative Complications Including, Infection, Seroma, Hematoma, Visceral Adherence, Allergy Etc |
| up to 12 months |
| Patient Satisfaction | at least 12 month post-operatively |
| Operative Time | From skin incision to closure (The expected median operating time is 36 minutes for unilateral and 50 minutes for bilateral repair) |
| Hospital Length of Stay | Duration of the hospital stay (expected average of 1 day) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Participants |
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| Secondary | Incidence of Groin Pain (Pain Score 0-10) | Posted | Number | participants | 12 month post-operatively |
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| Secondary | Analgesic Use | Not Posted | The day of the discharge (an expected average of 1 day), 1month and at least 12 month post-operatively |
| Secondary | Postoperative Complications Including, Infection, Seroma, Hematoma, Visceral Adherence, Allergy Etc | Posted | Number | participants | up to 12 months |
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| Secondary | Patient Satisfaction | Posted | Number | participants | at least 12 month post-operatively |
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| Secondary | Operative Time | Not Posted | From skin incision to closure (The expected median operating time is 36 minutes for unilateral and 50 minutes for bilateral repair) |
| Secondary | Hospital Length of Stay | Posted | Mean | Standard Deviation | Days | Duration of the hospital stay (expected average of 1 day) |
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| 0 |
| 169 |
| 0 |
| 169 |
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