TAPP Inguinal Hernia Repair With Self-fixating Parietex™ ProGrip™ Mesh
|ClinicalTrials.gov Identifier: NCT01481376|
Recruitment Status : Completed
First Posted : November 29, 2011
Results First Posted : March 17, 2014
Last Update Posted : January 7, 2016
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
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||200 participants|
|Official Title:||Laparoscopic Transabdominal Preperitoneal (TAPP) Inguinal Hernia Repair With Self-fixating Parietex™ ProGrip™ Mesh: A Retrospective Study With 12 Month Follow-up|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||April 2013|
- Proportion of Subjects Who Experience Hernia Recurrence (Defect Treated Initially With Parietex™ ProGrip™) Within 12 Months Post-surgery. [ Time Frame: 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.
- Incidence of Groin Pain (Pain Score 0-10) [ Time Frame: 12 month post-operatively ]
- Analgesic Use [ Time Frame: 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 [ Time Frame: up to 12 months ]
- Patient Satisfaction [ Time Frame: at least 12 month post-operatively ]
- 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) ]
- Hospital Length of Stay [ Time Frame: Duration of the hospital stay (expected average of 1 day) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01481376
|Evangelisches Krankenhaus Zweibrücken - Obere Himmelsbergstr. 38|
|Zweibrücken, Germany, 66482|
|Principal Investigator:||Dieter BIRK, MD||Evangelisches Krankenhaus Zweibrücken - Obere Himmelsbergstr. 38 - 66482 Zweibrücken - GERMANY|