Clinical trial NCT01481376: TAPP Inguinal Hernia Repair With Self-fixating Parietex™ ProGrip™ Mesh
Official title: Laparoscopic Transabdominal Preperitoneal (TAPP) Inguinal Hernia Repair With Self-fixating Parietex™ ProGrip™ Mesh: A Retrospective Study With 12 Month Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Complications
Keywords: Parietex™ ProGrip™
Laparoscopic Transabdominal preperitoneal
TAPP
Inguinal hernia repair
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2011-11-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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. Subjects must meet the protocol outlined eligibility criteria to be included in the study.

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


Eligibility criteria: 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 exclusion criteria are not eligible for study participation:

  * Patients with previous laparoscopic Inguinal hernia repair
  * Emergency procedures
  * Patients with incarcerated hernias

Primary outcomes:
measure: Proportion of Subjects Who Experience Hernia Recurrence (Defect Treated Initially With Parietex™ ProGrip™) Within 12 Months Post-surgery.
timeFrame: At least 12 months post-surgery
Secondary outcomes:
measure: Incidence of Groin Pain (Pain Score 0-10)
timeFrame: 12 month post-operatively
measure: Analgesic Use
timeFrame: The day of the discharge (an expected average of 1 day), 1month and at least 12 month post-operatively
measure: Postoperative Complications Including, Infection, Seroma, Hematoma, Visceral Adherence, Allergy Etc
timeFrame: up to 12 months
measure: Patient Satisfaction
timeFrame: at least 12 month post-operatively
measure: Operative Time
timeFrame: From skin incision to closure (The expected median operating time is 36 minutes for unilateral and 50 minutes for bilateral repair)
measure: Hospital Length of Stay
timeFrame: Duration of the hospital stay (expected average of 1 day)
Other outcomes:
Locations:
city: Zweibrücken
country: Germany
facility: Evangelisches Krankenhaus Zweibrücken - Obere Himmelsbergstr. 38
Study officials:
affiliation: Evangelisches Krankenhaus Zweibrücken - Obere Himmelsbergstr. 38 - 66482 Zweibrücken - GERMANY
name: Dieter BIRK, MD
role: PRINCIPAL_INVESTIGATOR
References: