Trial Outcomes & Findings for AbsorbaTack Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair (NCT NCT00749268)

Last Updated: 2015-10-05

Results Overview

Pain Intensity Numeric Rating Scale (PI-NRS) - change from baseline. Treatments analyzed within inguinal arm and within ventral arm. Scale is 0 - 10 with 0 being "no pain" and 10 being "worst pain imaginable".

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

216 participants

Primary outcome timeframe

Discharge, Month 1, Month 6, Month 12

Results posted on

2015-10-05

Participant Flow

Between November 4, 2008 and November 4, 2010, 117 subjects signed informed consent for the inguinal hernia arm of the study and 113 for the ventral arm. Of those subjects who consented, 106 and 110 were randomized to a treatment group (either AbsorbaTack™ or ProTack™) for inguinal and ventral hernia repair, respectively.

Participant milestones

Participant milestones
Measure	Inguinal Arm Patients with inguinal hernias are randomized to receive either AbsorbaTack or ProTack. The two treatments are compared within a single hernia type but not across hernia types.	Ventral Arm Patients with ventral hernias are randomized to receive either AbsorbaTack or ProTack. The two treatments are compared within a single hernia type but not across hernia types.
Overall Study STARTED	106	110
Overall Study COMPLETED	72	74
Overall Study NOT COMPLETED	34	36

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

AbsorbaTack Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Inguinal Arm - AbsorbaTack n=52 Participants Inguinal hernia study arm with AbsorbaTack as treatment.	Inguinal Arm - ProTack n=52 Participants Inguinal hernia study arm with ProTack as treatment.	Ventral Arm - Absorbatack n=56 Participants Ventral hernia study arm with AbsorbaTack as treatment.	Ventral Arm - ProTack n=54 Participants Ventral hernia study arm with ProTack as treatment.	Total n=214 Participants Total of all reporting groups
Age, Continuous	48.6 years STANDARD_DEVIATION 15.5 • n=5 Participants	53.3 years STANDARD_DEVIATION 12.3 • n=7 Participants	50.3 years STANDARD_DEVIATION 11.3 • n=5 Participants	53.8 years STANDARD_DEVIATION 12.9 • n=4 Participants	51.49 years STANDARD_DEVIATION 13.15 • n=21 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	7 Participants n=7 Participants	20 Participants n=5 Participants	27 Participants n=4 Participants	55 Participants n=21 Participants
Sex: Female, Male Male	51 Participants n=5 Participants	45 Participants n=7 Participants	36 Participants n=5 Participants	27 Participants n=4 Participants	159 Participants n=21 Participants
Region of Enrollment United States	34 participants n=5 Participants	33 participants n=7 Participants	31 participants n=5 Participants	29 participants n=4 Participants	127 participants n=21 Participants
Region of Enrollment France	14 participants n=5 Participants	13 participants n=7 Participants	19 participants n=5 Participants	19 participants n=4 Participants	65 participants n=21 Participants
Region of Enrollment Germany	4 participants n=5 Participants	6 participants n=7 Participants	6 participants n=5 Participants	6 participants n=4 Participants	22 participants n=21 Participants

PRIMARY outcome

Timeframe: Discharge, Month 1, Month 6, Month 12

Population: 1 patient in the Ventral Arm - AbsorbaTack had only pre-operative pain scores available so was unable to be included in this analysis.

Outcome measures

Outcome measures
Measure	Inguinal Arm - AbsorbaTack n=52 Participants Inguinal hernia study arm with AbsorbaTack as treatment.	Inguinal Arm - ProTack n=52 Participants Inguinal hernia study arm with ProTack as treatment.	Ventral Arm - Absorbatack n=55 Participants	Ventral Arm - ProTack n=54 Participants
Postoperative Pain Change from baseline - discharge	.8 units on a scale Standard Deviation 2.8	2.0 units on a scale Standard Deviation 2.2	2.2 units on a scale Standard Deviation 3.8	3.3 units on a scale Standard Deviation 3.6
Postoperative Pain Change from baseline - 1 month	-1.1 units on a scale Standard Deviation 2.7	-.4 units on a scale Standard Deviation 1.8	-.7 units on a scale Standard Deviation 3.0	.5 units on a scale Standard Deviation 1.9
Postoperative Pain Change from baseline - 6 months	-1.8 units on a scale Standard Deviation 2.4	-.6 units on a scale Standard Deviation 1.8	-1.3 units on a scale Standard Deviation 2.8	-.6 units on a scale Standard Deviation 1.7
Postoperative Pain Change from baseline - 1 year	-1.2 units on a scale Standard Deviation 2.3	-.9 units on a scale Standard Deviation 1.6	-1.8 units on a scale Standard Deviation 2.7	-.8 units on a scale Standard Deviation 1.8

PRIMARY outcome

Timeframe: One year

Outcome measures

Outcome measures
Measure	Inguinal Arm - AbsorbaTack n=53 Participants Inguinal hernia study arm with AbsorbaTack as treatment.	Inguinal Arm - ProTack n=51 Participants Inguinal hernia study arm with ProTack as treatment.	Ventral Arm - Absorbatack n=55 Participants	Ventral Arm - ProTack n=54 Participants
Safety for Laparoscopic Hernia Repair as Measured by Number of Patients Experiencing Device Related Events	7 participants	8 participants	7 participants	8 participants

SECONDARY outcome

Timeframe: Pre-op, Month 1, Month 6, 1 year

Population: Participant # above reflects those at pre-op. Arms ended study with 34, 39, 36 and 39 subjects, respectively.

Quality of life as measured by the SF-12 which is a multipurpose short form survey with 12 questions. The questions were combined, scored, and weighted to create a scale that provide glimpses into physical functioning and overall health-related-quality of life. The Physical Composite Score was computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

Outcome measures

Outcome measures
Measure	Inguinal Arm - AbsorbaTack n=50 Participants Inguinal hernia study arm with AbsorbaTack as treatment.	Inguinal Arm - ProTack n=50 Participants Inguinal hernia study arm with ProTack as treatment.	Ventral Arm - Absorbatack n=55 Participants	Ventral Arm - ProTack n=53 Participants
Quality of Life Pre-Op	48.8 units on a scale Standard Deviation 8.6	50.6 units on a scale Standard Deviation 8.1	46.1 units on a scale Standard Deviation 9.3	49.0 units on a scale Standard Deviation 9.1
Quality of Life 1 Month	49.1 units on a scale Standard Deviation 7.9	50.2 units on a scale Standard Deviation 7.0	45.4 units on a scale Standard Deviation 9.5	45.2 units on a scale Standard Deviation 9.0
Quality of Life 6 Month	55.3 units on a scale Standard Deviation 6.6	54.4 units on a scale Standard Deviation 6.3	51.6 units on a scale Standard Deviation 9.4	51.1 units on a scale Standard Deviation 7.6
Quality of Life 1 year	55.8 units on a scale Standard Deviation 7.4	53.8 units on a scale Standard Deviation 6.0	52.0 units on a scale Standard Deviation 8.1	53.3 units on a scale Standard Deviation 6.6

SECONDARY outcome

Timeframe: Discharge, 1 Month, 6 Month, 1 year

Outcome measures

Outcome measures
Measure	Inguinal Arm - AbsorbaTack n=52 Participants Inguinal hernia study arm with AbsorbaTack as treatment.	Inguinal Arm - ProTack n=52 Participants Inguinal hernia study arm with ProTack as treatment.	Ventral Arm - Absorbatack n=56 Participants	Ventral Arm - ProTack n=54 Participants
Hernia Recurrence Discharge	0 participants	1 participants	0 participants	0 participants
Hernia Recurrence 1 Month	0 participants	1 participants	1 participants	2 participants
Hernia Recurrence 6 Month	2 participants	1 participants	3 participants	0 participants
Hernia Recurrence 1 Year	0 participants	1 participants	1 participants	0 participants

Adverse Events

Inguinal Arm - AbsorbaTack

Serious events: 6 serious events

Other events: 17 other events

Deaths: 0 deaths

Inguinal Arm - ProTack

Serious events: 6 serious events

Other events: 20 other events

Deaths: 0 deaths

Ventral Arm - Absorbatack

Serious events: 8 serious events

Other events: 24 other events

Deaths: 0 deaths

Ventral Arm - ProTack

Serious events: 9 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Inguinal Arm - AbsorbaTack n=53 participants at risk Inguinal hernia study arm with AbsorbaTack as treatment.	Inguinal Arm - ProTack n=51 participants at risk Inguinal hernia study arm with ProTack as treatment.	Ventral Arm - Absorbatack n=55 participants at risk Ventral hernia study arm with AbsorbaTack as treatment.	Ventral Arm - ProTack n=54 participants at risk Ventral hernia study arm with ProTack as treatment.
Injury, poisoning and procedural complications Seroma	17.0% 9/53 • Adverse events collected from time of randomization through 1 year. Inguinal Arm - 1 patient randomized to ProTack group was treated w/AbsorbaTack and 1 patient randomized to the AbsorbaTack group was treated w/ProTack, so these 2 patients were not included in the safety analysis set. Ventral Arm - 1 patient randomized to the AbsorbaTack group was treated w/ProTack so what not included in the safety analysis set	23.5% 12/51 • Adverse events collected from time of randomization through 1 year. Inguinal Arm - 1 patient randomized to ProTack group was treated w/AbsorbaTack and 1 patient randomized to the AbsorbaTack group was treated w/ProTack, so these 2 patients were not included in the safety analysis set. Ventral Arm - 1 patient randomized to the AbsorbaTack group was treated w/ProTack so what not included in the safety analysis set	23.6% 13/55 • Adverse events collected from time of randomization through 1 year. Inguinal Arm - 1 patient randomized to ProTack group was treated w/AbsorbaTack and 1 patient randomized to the AbsorbaTack group was treated w/ProTack, so these 2 patients were not included in the safety analysis set. Ventral Arm - 1 patient randomized to the AbsorbaTack group was treated w/ProTack so what not included in the safety analysis set	35.2% 19/54 • Adverse events collected from time of randomization through 1 year. Inguinal Arm - 1 patient randomized to ProTack group was treated w/AbsorbaTack and 1 patient randomized to the AbsorbaTack group was treated w/ProTack, so these 2 patients were not included in the safety analysis set. Ventral Arm - 1 patient randomized to the AbsorbaTack group was treated w/ProTack so what not included in the safety analysis set
Gastrointestinal disorders Abdominal Pain	0.00% 0/53 • Adverse events collected from time of randomization through 1 year. Inguinal Arm - 1 patient randomized to ProTack group was treated w/AbsorbaTack and 1 patient randomized to the AbsorbaTack group was treated w/ProTack, so these 2 patients were not included in the safety analysis set. Ventral Arm - 1 patient randomized to the AbsorbaTack group was treated w/ProTack so what not included in the safety analysis set	5.9% 3/51 • Adverse events collected from time of randomization through 1 year. Inguinal Arm - 1 patient randomized to ProTack group was treated w/AbsorbaTack and 1 patient randomized to the AbsorbaTack group was treated w/ProTack, so these 2 patients were not included in the safety analysis set. Ventral Arm - 1 patient randomized to the AbsorbaTack group was treated w/ProTack so what not included in the safety analysis set	7.3% 4/55 • Adverse events collected from time of randomization through 1 year. Inguinal Arm - 1 patient randomized to ProTack group was treated w/AbsorbaTack and 1 patient randomized to the AbsorbaTack group was treated w/ProTack, so these 2 patients were not included in the safety analysis set. Ventral Arm - 1 patient randomized to the AbsorbaTack group was treated w/ProTack so what not included in the safety analysis set	7.4% 4/54 • Adverse events collected from time of randomization through 1 year. Inguinal Arm - 1 patient randomized to ProTack group was treated w/AbsorbaTack and 1 patient randomized to the AbsorbaTack group was treated w/ProTack, so these 2 patients were not included in the safety analysis set. Ventral Arm - 1 patient randomized to the AbsorbaTack group was treated w/ProTack so what not included in the safety analysis set
Injury, poisoning and procedural complications Incision Site Pain	9.4% 5/53 • Adverse events collected from time of randomization through 1 year. Inguinal Arm - 1 patient randomized to ProTack group was treated w/AbsorbaTack and 1 patient randomized to the AbsorbaTack group was treated w/ProTack, so these 2 patients were not included in the safety analysis set. Ventral Arm - 1 patient randomized to the AbsorbaTack group was treated w/ProTack so what not included in the safety analysis set	3.9% 2/51 • Adverse events collected from time of randomization through 1 year. Inguinal Arm - 1 patient randomized to ProTack group was treated w/AbsorbaTack and 1 patient randomized to the AbsorbaTack group was treated w/ProTack, so these 2 patients were not included in the safety analysis set. Ventral Arm - 1 patient randomized to the AbsorbaTack group was treated w/ProTack so what not included in the safety analysis set	5.5% 3/55 • Adverse events collected from time of randomization through 1 year. Inguinal Arm - 1 patient randomized to ProTack group was treated w/AbsorbaTack and 1 patient randomized to the AbsorbaTack group was treated w/ProTack, so these 2 patients were not included in the safety analysis set. Ventral Arm - 1 patient randomized to the AbsorbaTack group was treated w/ProTack so what not included in the safety analysis set	5.6% 3/54 • Adverse events collected from time of randomization through 1 year. Inguinal Arm - 1 patient randomized to ProTack group was treated w/AbsorbaTack and 1 patient randomized to the AbsorbaTack group was treated w/ProTack, so these 2 patients were not included in the safety analysis set. Ventral Arm - 1 patient randomized to the AbsorbaTack group was treated w/ProTack so what not included in the safety analysis set
Renal and urinary disorders Urinary Retention	5.7% 3/53 • Adverse events collected from time of randomization through 1 year. Inguinal Arm - 1 patient randomized to ProTack group was treated w/AbsorbaTack and 1 patient randomized to the AbsorbaTack group was treated w/ProTack, so these 2 patients were not included in the safety analysis set. Ventral Arm - 1 patient randomized to the AbsorbaTack group was treated w/ProTack so what not included in the safety analysis set	2.0% 1/51 • Adverse events collected from time of randomization through 1 year. Inguinal Arm - 1 patient randomized to ProTack group was treated w/AbsorbaTack and 1 patient randomized to the AbsorbaTack group was treated w/ProTack, so these 2 patients were not included in the safety analysis set. Ventral Arm - 1 patient randomized to the AbsorbaTack group was treated w/ProTack so what not included in the safety analysis set	7.3% 4/55 • Adverse events collected from time of randomization through 1 year. Inguinal Arm - 1 patient randomized to ProTack group was treated w/AbsorbaTack and 1 patient randomized to the AbsorbaTack group was treated w/ProTack, so these 2 patients were not included in the safety analysis set. Ventral Arm - 1 patient randomized to the AbsorbaTack group was treated w/ProTack so what not included in the safety analysis set	5.6% 3/54 • Adverse events collected from time of randomization through 1 year. Inguinal Arm - 1 patient randomized to ProTack group was treated w/AbsorbaTack and 1 patient randomized to the AbsorbaTack group was treated w/ProTack, so these 2 patients were not included in the safety analysis set. Ventral Arm - 1 patient randomized to the AbsorbaTack group was treated w/ProTack so what not included in the safety analysis set
Vascular disorders Haemorrhage	0.00% 0/53 • Adverse events collected from time of randomization through 1 year. Inguinal Arm - 1 patient randomized to ProTack group was treated w/AbsorbaTack and 1 patient randomized to the AbsorbaTack group was treated w/ProTack, so these 2 patients were not included in the safety analysis set. Ventral Arm - 1 patient randomized to the AbsorbaTack group was treated w/ProTack so what not included in the safety analysis set	5.9% 3/51 • Adverse events collected from time of randomization through 1 year. Inguinal Arm - 1 patient randomized to ProTack group was treated w/AbsorbaTack and 1 patient randomized to the AbsorbaTack group was treated w/ProTack, so these 2 patients were not included in the safety analysis set. Ventral Arm - 1 patient randomized to the AbsorbaTack group was treated w/ProTack so what not included in the safety analysis set	0.00% 0/55 • Adverse events collected from time of randomization through 1 year. Inguinal Arm - 1 patient randomized to ProTack group was treated w/AbsorbaTack and 1 patient randomized to the AbsorbaTack group was treated w/ProTack, so these 2 patients were not included in the safety analysis set. Ventral Arm - 1 patient randomized to the AbsorbaTack group was treated w/ProTack so what not included in the safety analysis set	1.9% 1/54 • Adverse events collected from time of randomization through 1 year. Inguinal Arm - 1 patient randomized to ProTack group was treated w/AbsorbaTack and 1 patient randomized to the AbsorbaTack group was treated w/ProTack, so these 2 patients were not included in the safety analysis set. Ventral Arm - 1 patient randomized to the AbsorbaTack group was treated w/ProTack so what not included in the safety analysis set
Gastrointestinal disorders Abdominal Discomfort	0.00% 0/53 • Adverse events collected from time of randomization through 1 year. Inguinal Arm - 1 patient randomized to ProTack group was treated w/AbsorbaTack and 1 patient randomized to the AbsorbaTack group was treated w/ProTack, so these 2 patients were not included in the safety analysis set. Ventral Arm - 1 patient randomized to the AbsorbaTack group was treated w/ProTack so what not included in the safety analysis set	0.00% 0/51 • Adverse events collected from time of randomization through 1 year. Inguinal Arm - 1 patient randomized to ProTack group was treated w/AbsorbaTack and 1 patient randomized to the AbsorbaTack group was treated w/ProTack, so these 2 patients were not included in the safety analysis set. Ventral Arm - 1 patient randomized to the AbsorbaTack group was treated w/ProTack so what not included in the safety analysis set	0.00% 0/55 • Adverse events collected from time of randomization through 1 year. Inguinal Arm - 1 patient randomized to ProTack group was treated w/AbsorbaTack and 1 patient randomized to the AbsorbaTack group was treated w/ProTack, so these 2 patients were not included in the safety analysis set. Ventral Arm - 1 patient randomized to the AbsorbaTack group was treated w/ProTack so what not included in the safety analysis set	5.6% 3/54 • Adverse events collected from time of randomization through 1 year. Inguinal Arm - 1 patient randomized to ProTack group was treated w/AbsorbaTack and 1 patient randomized to the AbsorbaTack group was treated w/ProTack, so these 2 patients were not included in the safety analysis set. Ventral Arm - 1 patient randomized to the AbsorbaTack group was treated w/ProTack so what not included in the safety analysis set

Additional Information

Jessica Carlson, Clinical Project Manager

Covidien

Phone: (203) 821-4734

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60