TAPP Inguinal Hernia Repair With Self-fixating Parietex™ ProGrip™ Mesh

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sofradim Production
ClinicalTrials.gov Identifier:
NCT01481376
First received: October 24, 2011
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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
Postoperative Complications

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Laparoscopic Transabdominal Preperitoneal (TAPP) Inguinal Hernia Repair With Self-fixating Parietex™ ProGrip™ Mesh: A Retrospective Study With 12 Month Follow-up

Resource links provided by NLM:


Further study details as provided by Sofradim Production:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Incidence of Groin Pain (Pain Score 0-10) [ Time Frame: 12 month post-operatively ] [ Designated as safety issue: Yes ]
  • Analgesic Use [ Time Frame: The day of the discharge (an expected average of 1 day), 1month and at least 12 month post-operatively ] [ Designated as safety issue: No ]
  • Postoperative Complications Including, Infection, Seroma, Hematoma, Visceral Adherence, Allergy Etc [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
  • Patient Satisfaction [ Time Frame: at least 12 month post-operatively ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Hospital Length of Stay [ Time Frame: Duration of the hospital stay (expected average of 1 day) ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: October 2011
Study Completion Date: April 2013
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01481376

Locations
Germany
Evangelisches Krankenhaus Zweibrücken - Obere Himmelsbergstr. 38
Zweibrücken, Germany, 66482
Sponsors and Collaborators
Sofradim Production
Investigators
Principal Investigator: Dieter BIRK, MD Evangelisches Krankenhaus Zweibrücken - Obere Himmelsbergstr. 38 - 66482 Zweibrücken - GERMANY
  More Information

No publications provided

Responsible Party: Sofradim Production
ClinicalTrials.gov Identifier: NCT01481376     History of Changes
Other Study ID Numbers: COVPTAP0161
Study First Received: October 24, 2011
Results First Received: December 6, 2013
Last Updated: January 29, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Sofradim Production:
Parietex™ ProGrip™
Laparoscopic Transabdominal preperitoneal
TAPP
Inguinal hernia repair

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Postoperative Complications
Pathological Conditions, Anatomical
Hernia, Abdominal
Pathologic Processes

ClinicalTrials.gov processed this record on August 18, 2014