Postoperative Complications
Conditions
Keywords
Parietex™ ProGrip™, Laparoscopic Transabdominal preperitoneal, TAPP, Inguinal hernia repair
Brief summary
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. * Single center study * Population: 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. 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: * Incidence of Groin Pain (pain score 0-10) and analgesic use at discharge, 1 month and 12 month postoperatively * Incidence of postoperative complications including, wound infection (any infection of the incision), mesh infection (an infection of the mesh), bleeding, mesh migration, mesh erosion, fistula, small bowel obstruction, seroma, hematuria, hematoma, inflammation, chronic pains/ inguinodynia, infection, visceral adherence, allergic reactions to the components of the product at discharge, 1month and 12 month post-operatively * Patient satisfaction * Operative time * Hospital length of stay
Interventions
None listed
Sponsors
Medtronic - MITG
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The following diagnosis will be included: * Inguinal hernia: unilateral or bilateral All subjects must meet the following inclusion criteria: * ≥18 years of age * Had undergone elective (non-emergent) primary surgical repair of the above diagnosis with Parietex ProGrip™ by Laparoscopic Transabdominal preperitoneal inguinal hernia repair between September 2008 to March 2010 * Post-operative follow-up ≥ 12 months or recurrence which occurs within the 12 months post-surgery (If subject has a known incidence of recurrence before the 12 months follow up, the subject will be included in the study.)
Exclusion criteria
* Subjects who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects Who Experience Hernia Recurrence (Defect Treated Initially With Parietex™ ProGrip™) Within 12 Months Post-surgery. | At least 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. |
Secondary
| Measure | Time frame |
|---|---|
| Analgesic Use | The day of the discharge (an expected average of 1 day), 1month and at least 12 month post-operatively |
| Postoperative Complications Including, Infection, Seroma, Hematoma, Visceral Adherence, Allergy Etc | up to 12 months |
| Incidence of Groin Pain (Pain Score 0-10) | 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) |
| Patient Satisfaction | at least 12 month post-operatively |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Parietex Progrip Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach | 169 |
| Total | 169 |
Baseline characteristics
| Characteristic | Parietex Progrip |
|---|---|
| Age, Continuous | 54.7 years |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 156 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 169 |
| serious Total, serious adverse events | 0 / 169 |
Outcome results
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.
Time frame: At least 12 months post-surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Parietex Progrip | Proportion of Subjects Who Experience Hernia Recurrence (Defect Treated Initially With Parietex™ ProGrip™) Within 12 Months Post-surgery. | 3 participants |
Secondary
Analgesic Use
Time frame: The day of the discharge (an expected average of 1 day), 1month and at least 12 month post-operatively
Secondary
Hospital Length of Stay
Time frame: Duration of the hospital stay (expected average of 1 day)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Parietex Progrip | Hospital Length of Stay | 2.1 Days | Standard Deviation 0.8 |
Secondary
Incidence of Groin Pain (Pain Score 0-10)
Time frame: 12 month post-operatively
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Parietex Progrip | Incidence of Groin Pain (Pain Score 0-10) | No/Low Pain (score 0-3) | 160 participants |
| Parietex Progrip | Incidence of Groin Pain (Pain Score 0-10) | Mild pain (Score 4-6) | 6 participants |
| Parietex Progrip | Incidence of Groin Pain (Pain Score 0-10) | Severe (score 7-10) | 2 participants |
Secondary
Operative Time
Time frame: From skin incision to closure (The expected median operating time is 36 minutes for unilateral and 50 minutes for bilateral repair)
Secondary
Patient Satisfaction
Time frame: at least 12 month post-operatively
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Parietex Progrip | Patient Satisfaction | Very satisfied/Satisfied | 162 participants |
| Parietex Progrip | Patient Satisfaction | Neutral | 2 participants |
| Parietex Progrip | Patient Satisfaction | Unsatisfied/Very unsatisfied | 5 participants |
Secondary
Postoperative Complications Including, Infection, Seroma, Hematoma, Visceral Adherence, Allergy Etc
Time frame: up to 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Parietex Progrip | Postoperative Complications Including, Infection, Seroma, Hematoma, Visceral Adherence, Allergy Etc | Hematoma/Seroma | 3 participants |
| Parietex Progrip | Postoperative Complications Including, Infection, Seroma, Hematoma, Visceral Adherence, Allergy Etc | Emphysema in the inguinal regions (both sides) | 1 participants |
| Parietex Progrip | Postoperative Complications Including, Infection, Seroma, Hematoma, Visceral Adherence, Allergy Etc | Secondary hemorrhage through the trocar's site | 2 participants |
| Parietex Progrip | Postoperative Complications Including, Infection, Seroma, Hematoma, Visceral Adherence, Allergy Etc | Hematuria | 1 participants |
| Parietex Progrip | Postoperative Complications Including, Infection, Seroma, Hematoma, Visceral Adherence, Allergy Etc | Swelling above the genital organs | 1 participants |