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Completed

NCT Number: NCT01481376

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

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

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Key information

Conditions

Postoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Evangelisches Krankenhaus Zweibrücken - Obere Himmelsbergstr. 38

Zweibrücken, 66482, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Incidence of Groin Pain (Pain Score 0-10)

    Time frame: 12 month post-operatively

  2. Analgesic Use

    Time frame: The day of the discharge (an expected average of 1 day), 1month and at least 12 month post-operatively

  3. Postoperative Complications Including, Infection, Seroma, Hematoma, Visceral Adherence, Allergy Etc

    Time frame: up to 12 months

  4. Patient Satisfaction

    Time frame: at least 12 month post-operatively

  5. 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)

  6. Hospital Length of Stay

    Time frame: Duration of the hospital stay (expected average of 1 day)

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study title

Laparoscopic Transabdominal Preperitoneal (TAPP) Inguinal Hernia Repair With Self-fixating Parietex™ ProGrip™ Mesh: A Retrospective Study With 12 Month Follow-up

Important dates

Study start
2011
Primary completion
2011
Study completion
2013
First posted
Nov 29, 2011
Registry last updated
Jan 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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