Trial Outcomes & Findings for TAPP Inguinal Hernia Repair With Self-fixating Parietex™ ProGrip™ Mesh (NCT NCT01481376)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

200 participants

Primary outcome timeframe

At least 12 months post-surgery

Results posted on

2016-01-07

Participant Flow

Participant milestones

Participant milestones
Measure	Parietex Progrip Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
Overall Study STARTED	200
Overall Study COMPLETED	169
Overall Study NOT COMPLETED	31

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Parietex Progrip n=169 Participants Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
Age, Continuous	54.7 years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	156 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Parietex Progrip n=169 Participants Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
Proportion of Subjects Who Experience Hernia Recurrence (Defect Treated Initially With Parietex™ ProGrip™) Within 12 Months Post-surgery.	3 participants

SECONDARY outcome

Timeframe: 12 month post-operatively

Outcome measures

Outcome measures
Measure	Parietex Progrip n=168 Participants Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
Incidence of Groin Pain (Pain Score 0-10) No/Low Pain (score 0-3)	160 participants
Incidence of Groin Pain (Pain Score 0-10) Mild pain (Score 4-6)	6 participants
Incidence of Groin Pain (Pain Score 0-10) Severe (score 7-10)	2 participants

SECONDARY outcome

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 12 months

Outcome measures

Outcome measures
Measure	Parietex Progrip n=169 Participants Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
Postoperative Complications Including, Infection, Seroma, Hematoma, Visceral Adherence, Allergy Etc Hematoma/Seroma	3 participants
Postoperative Complications Including, Infection, Seroma, Hematoma, Visceral Adherence, Allergy Etc Emphysema in the inguinal regions (both sides)	1 participants
Postoperative Complications Including, Infection, Seroma, Hematoma, Visceral Adherence, Allergy Etc Secondary hemorrhage through the trocar's site	2 participants
Postoperative Complications Including, Infection, Seroma, Hematoma, Visceral Adherence, Allergy Etc Hematuria	1 participants
Postoperative Complications Including, Infection, Seroma, Hematoma, Visceral Adherence, Allergy Etc Swelling above the genital organs	1 participants

SECONDARY outcome

Timeframe: at least 12 month post-operatively

Outcome measures

Outcome measures
Measure	Parietex Progrip n=169 Participants Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
Patient Satisfaction Very satisfied/Satisfied	162 participants
Patient Satisfaction Neutral	2 participants
Patient Satisfaction Unsatisfied/Very unsatisfied	5 participants

SECONDARY outcome

Timeframe: From skin incision to closure (The expected median operating time is 36 minutes for unilateral and 50 minutes for bilateral repair)

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	Parietex Progrip n=169 Participants Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
Hospital Length of Stay	2.1 Days Standard Deviation 0.8

Adverse Events

Parietex Progrip

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Docteur Dieter BIRK

Surgical Department of the Protestant Hospital

Phone: 06332 422120

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60