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

• Sponsor: Medtronic - MITG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01481376
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Duration (Months): 18
• Patients Per Site Per Month: 11.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Complications

Study Design

• Study Type: Observational
• Actual Enrollment: 200 participants
• 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
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Apr 1, 2013

Outcome Measures

Primary Outcome Measures

1. Proportion of Subjects Who Experience Hernia Recurrence (Defect Treated Initially With Parietex™ ProGrip™) Within 12 Months Post-surgery. [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 Outcome Measures

1. Incidence of Groin Pain (Pain Score 0-10) [12 month post-operatively]

2. Analgesic Use [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 [up to 12 months]

4. Patient Satisfaction [at least 12 month post-operatively]

5. Operative Time [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 [Duration of the hospital stay (expected average of 1 day)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Evangelisches Krankenhaus Zweibrücken - Obere Himmelsbergstr. 38	Zweibrücken		Germany	66482

Sponsors and Collaborators

• Medtronic - MITG

Investigators

• Principal Investigator: Dieter BIRK, MD, Evangelisches Krankenhaus Zweibrücken - Obere Himmelsbergstr. 38 - 66482 Zweibrücken - GERMANY

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic - MITG
• ClinicalTrials.gov Identifier: NCT01481376
• Other Study ID Numbers: COVPTAP0161
• First Posted: Nov 29, 2011
• Last Update Posted: Jan 7, 2016
• Last Verified: Dec 1, 2015

• Keywords provided by Medtronic - MITG: Parietex™ ProGrip™; Laparoscopic Transabdominal preperitoneal; TAPP; Inguinal hernia repair
• Additional relevant MeSH terms: Hernia; Postoperative Complications; Hernia, Inguinal

Study Results

Participant Flow

Arm/Group Title	Parietex Progrip
Arm/Group Description	Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
Period Title: Overall Study
STARTED	200
COMPLETED	169
NOT COMPLETED	31

Baseline Characteristics

Arm/Group Title	Parietex Progrip
Arm/Group Description	Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
Overall Participants	169
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	54.7
Sex: Female, Male (Count of Participants)
Female	13 7.7%
Male	156 92.3%

Outcome Measures

1. Primary Outcome

Title	Proportion of Subjects Who Experience Hernia Recurrence (Defect Treated Initially With Parietex™ ProGrip™) Within 12 Months Post-surgery.
Description	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.
Time Frame	At least 12 months post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Parietex Progrip
Arm/Group Description	Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
Measure Participants	169
Number [participants]	3 1.8%

2. Secondary Outcome

Title	Incidence of Groin Pain (Pain Score 0-10)
Time Frame	12 month post-operatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Parietex Progrip
Arm/Group Description	Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
Measure Participants	168
No/Low Pain (score 0-3)	160 94.7%
Mild pain (Score 4-6)	6 3.6%
Severe (score 7-10)	2 1.2%

3. Secondary Outcome

Title	Analgesic Use
Time Frame	The day of the discharge (an expected average of 1 day), 1month and at least 12 month post-operatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Postoperative Complications Including, Infection, Seroma, Hematoma, Visceral Adherence, Allergy Etc
Time Frame	up to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Parietex Progrip
Arm/Group Description	Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
Measure Participants	169
Hematoma/Seroma	3 1.8%
Emphysema in the inguinal regions (both sides)	1 0.6%
Secondary hemorrhage through the trocar's site	2 1.2%
Hematuria	1 0.6%
Swelling above the genital organs	1 0.6%

5. Secondary Outcome

Title	Patient Satisfaction
Time Frame	at least 12 month post-operatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Parietex Progrip
Arm/Group Description	Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
Measure Participants	169
Very satisfied/Satisfied	162 95.9%
Neutral	2 1.2%
Unsatisfied/Very unsatisfied	5 3%

6. Secondary Outcome

Title	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

Title	Hospital Length of Stay
Time Frame	Duration of the hospital stay (expected average of 1 day)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Parietex Progrip
Arm/Group Description	Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
Measure Participants	169
Mean (Standard Deviation) [Days]	2.1 (0.8)

Adverse Events

Arm/Group Title	Parietex Progrip
Arm/Group Description	Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
All Cause Mortality
	Parietex Progrip
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Parietex Progrip
	Affected / at Risk (%)	# Events
Total	0/169 (0%)
Other (Not Including Serious) Adverse Events
	Parietex Progrip
	Affected / at Risk (%)	# Events
Total	0/169 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.