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

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01481376
• Other study ID #: COVPTAP0161
• Status: Completed
• Phase: N/A
• First received: October 24, 2011
• Last updated: December 8, 2015
• Start date: October 2011
• Est. completion date: April 2013

Study information

• Verified date: December 2015
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2013
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hernia, Inguinal
• Postoperative Complications

Locations

Country	Name	City	State
Germany	Evangelisches Krankenhaus Zweibrücken - Obere Himmelsbergstr. 38	Zweibrücken

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Incidence of Groin Pain (Pain Score 0-10)		12 month post-operatively	Yes
Secondary	Analgesic Use		The day of the discharge (an expected average of 1 day), 1month and at least 12 month post-operatively	No
Secondary	Postoperative Complications Including, Infection, Seroma, Hematoma, Visceral Adherence, Allergy Etc		up to 12 months	Yes
Secondary	Patient Satisfaction		at least 12 month post-operatively	No
Secondary	Operative Time		From skin incision to closure (The expected median operating time is 36 minutes for unilateral and 50 minutes for bilateral repair)	No
Secondary	Hospital Length of Stay		Duration of the hospital stay (expected average of 1 day)	No