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

NCT01481376 | Completed Results

• 1 other identifier: COVPTAP0161
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Complications

Keywords

Parietex™ ProGrip™; Laparoscopic Transabdominal preperitoneal; TAPP; Inguinal hernia repair

Outcome Measures

Primary Outcomes (1)

• 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.

  At least 12 months post-surgery

Secondary Outcomes (6)

• Incidence of Groin Pain (Pain Score 0-10)

  12 month post-operatively

• 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

• Patient Satisfaction

  at least 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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• The following diagnosis will be included:
• Inguinal hernia: unilateral or bilateral
• ≥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.)

You may not qualify if:

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

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

Evangelisches Krankenhaus Zweibrücken - Obere Himmelsbergstr. 38

Zweibrücken, 66482, Germany

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Docteur Dieter BIRK
• Organization: Surgical Department of the Protestant Hospital

06332 422120

Study Officials

• Dieter BIRK, MD

  Evangelisches Krankenhaus Zweibrücken - Obere Himmelsbergstr. 38 - 66482 Zweibrücken - GERMANY

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: November 29, 2011
• Study Start: October 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: April 1, 2013
• Last Updated: January 7, 2016
• Results First Posted: March 17, 2014

Record last verified: 2015-12

Locations

DE (1)