Trial Outcomes & Findings for Comparative Study on Self-adhesive Mesh for Open Inguinal Hernia Repair (NCT NCT00960011)

NCT ID: NCT00960011

Last Updated: 2020-04-15

Results Overview

It measures the total operating time of 2 groups, measured from time started the skin incision to time finishing wound closure in terms of minutes.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 58 participants
• Primary outcome timeframe: Intra-operative record
• Results posted on: 2020-04-15

Participant Flow

Participant milestones

Measure	PROGRIP Use of PROGRIP mesh for open inguinal hernia repair PROGRIP: Use of PROGRIP mesh for open inguinal hernia repair	POLYPROPYLENE Use of Polypropylene mesh for open inguinal hernia repair POLYPROPYLENE: Use of Polypropylene mesh in open inguinal hernia repair
Overall Study STARTED	33	25
Overall Study COMPLETED	22	23
Overall Study NOT COMPLETED	11	2

Reasons for withdrawal

Measure	PROGRIP Use of PROGRIP mesh for open inguinal hernia repair PROGRIP: Use of PROGRIP mesh for open inguinal hernia repair	POLYPROPYLENE Use of Polypropylene mesh for open inguinal hernia repair POLYPROPYLENE: Use of Polypropylene mesh in open inguinal hernia repair
Overall Study Death	5	0
Overall Study Lost to Follow-up	6	2

Baseline Characteristics

Comparative Study on Self-adhesive Mesh for Open Inguinal Hernia Repair

Baseline characteristics by cohort

Measure	PROGRIP n=22 Participants Use of PROGRIP mesh for open inguinal hernia repair PROGRIP: Use of PROGRIP mesh for open inguinal hernia repair	POLYPROPYLENE n=23 Participants Use of Polypropylene mesh for open inguinal hernia repair POLYPROPYLENE: Use of Polypropylene mesh in open inguinal hernia repair	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Age, Continuous	62.0 years STANDARD_DEVIATION 15.7 • n=5 Participants	62.6 years STANDARD_DEVIATION 16.0 • n=7 Participants	62.3 years STANDARD_DEVIATION 15.7 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	22 Participants n=7 Participants	40 Participants n=5 Participants
Region of Enrollment Hong Kong	22 participants n=5 Participants	23 participants n=7 Participants	45 participants n=5 Participants

PRIMARY outcome

Timeframe: Intra-operative record

It measures the total operating time of 2 groups, measured from time started the skin incision to time finishing wound closure in terms of minutes.

Outcome measures

Measure	PROGRIP(PG) n=22 Participants It measures the total operating time of using PROGRIP mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.	POLYPROPYLENE(PL) n=23 Participants It measures the total operating time of using POLYPROPYLENE mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.
Operating Time From Skin Incision to Wound Closure	39.2 minutes Standard Deviation 9.8	47.7 minutes Standard Deviation 7.6

SECONDARY outcome

Timeframe: Intra-operative record

Time from mesh place to end of operation, and total time of operation

Outcome measures

Measure	PROGRIP(PG) n=23 Participants It measures the total operating time of using PROGRIP mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.	POLYPROPYLENE(PL) n=22 Participants It measures the total operating time of using POLYPROPYLENE mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.
Mesh Placement Time, Total Operative Time Mesh placement time	21 Minutes Interval 14.8 to 27.2	11.8 Minutes Interval 8.7 to 14.9
Mesh Placement Time, Total Operative Time Total Operative time	47.7 Minutes Interval 39.7 to 55.7	39.2 Minutes Interval 29.4 to 49.0

SECONDARY outcome

Timeframe: 1 week after operation

Seroma formation at first follow-up, go by clinical

Outcome measures

Measure	PROGRIP(PG) n=22 Participants It measures the total operating time of using PROGRIP mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.	POLYPROPYLENE(PL) n=23 Participants It measures the total operating time of using POLYPROPYLENE mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.
Seroma Formation at First Follow-up	5 number of patient with seroma at 1 week	8 number of patient with seroma at 1 week

SECONDARY outcome

Timeframe: 6 years after operation

Overall recurrence at 6 years, including all recurrence

Outcome measures

Measure	PROGRIP(PG) n=22 Participants It measures the total operating time of using PROGRIP mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.	POLYPROPYLENE(PL) n=23 Participants It measures the total operating time of using POLYPROPYLENE mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.
Overall Recurrence at 6 Years	0 participants	1 participants

SECONDARY outcome

Timeframe: 6 years after operation

Patient with persistent chronic pain sensation at 6 years after operation. It described as painful sensation feeling around the operated site which is persistent and causing disturbance to daily normal life and attracted patients' attention.

Outcome measures

Measure	PROGRIP(PG) n=22 Participants It measures the total operating time of using PROGRIP mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.	POLYPROPYLENE(PL) n=23 Participants It measures the total operating time of using POLYPROPYLENE mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.
Chronic Pain at 6 Years	3 participants	3 participants

SECONDARY outcome

Timeframe: 6 years after operations

Patient with testicular atrophy from post-op to 6 years after operation, by clinical examination

Outcome measures

Measure	PROGRIP(PG) n=22 Participants It measures the total operating time of using PROGRIP mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.	POLYPROPYLENE(PL) n=23 Participants It measures the total operating time of using POLYPROPYLENE mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.
Patient With Testicular Atrophy From Post-op to 6 Years After Operation	1 participants	2 participants

SECONDARY outcome

Timeframe: 6 years after operation

Patient with clinical palpable mesh at 6 years after operation

Outcome measures

Measure	PROGRIP(PG) n=22 Participants It measures the total operating time of using PROGRIP mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.	POLYPROPYLENE(PL) n=23 Participants It measures the total operating time of using POLYPROPYLENE mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.
Patient With Palpable Mesh at 6 Years After Operation	1 participants	3 participants

SECONDARY outcome

Timeframe: 6 years after operation

Patient with persistent chronic discomfort at 6 years after operation. It described as an unpleasant feeling around the operated site which is persistent and causing disturbance to daily normal life and attracted patients' attention. It is differentiate from pain sensation.

Outcome measures

Measure	PROGRIP(PG) n=22 Participants It measures the total operating time of using PROGRIP mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.	POLYPROPYLENE(PL) n=23 Participants It measures the total operating time of using POLYPROPYLENE mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.
Patient With Chronic Discomfort at 6 Years After Operation	1 participants	1 participants

SECONDARY outcome

Timeframe: 6 years after operation

pain or discomfort which affecting daily activities at 6 years after operation

Outcome measures

Measure	PROGRIP(PG) n=22 Participants It measures the total operating time of using PROGRIP mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.	POLYPROPYLENE(PL) n=23 Participants It measures the total operating time of using POLYPROPYLENE mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.
Pain or Discomfort Affecting Daily Activities at 6 Years After Operation	1 participants	0 participants

SECONDARY outcome

Timeframe: 1 week after operation

Total Number of Analgesic Used: Tablets

Outcome measures

Measure	PROGRIP(PG) n=22 Participants It measures the total operating time of using PROGRIP mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.	POLYPROPYLENE(PL) n=23 Participants It measures the total operating time of using POLYPROPYLENE mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.
Total Number of Analgesic Used	10.4 Tablets Standard Deviation 9.1	6.7 Tablets Standard Deviation 8.2

SECONDARY outcome

Timeframe: 1 week after operation

Visual Analogue Score for measurement of wound pain at rest 1 week after operation

Outcome measures

Measure	PROGRIP(PG) n=22 Participants It measures the total operating time of using PROGRIP mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.	POLYPROPYLENE(PL) n=23 Participants It measures the total operating time of using POLYPROPYLENE mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.
Wound Pain at Rest at 1 Week After Operation	0.18 score on a scale Standard Deviation 0.39	0.13 score on a scale Standard Deviation 0.34

SECONDARY outcome

Timeframe: 1 week after operation

wound pain on coughingt at 1 week after operation (Visual Analogue Score). It was in the form of 0-10 where 0 is no pain and 10 is maximal pain they experienced in their life. The higher the value, the more painful it is.

Outcome measures

Measure	PROGRIP(PG) n=22 Participants It measures the total operating time of using PROGRIP mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.	POLYPROPYLENE(PL) n=23 Participants It measures the total operating time of using POLYPROPYLENE mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.
Wound Pain on Coughing at 1 Week After Operation	0.81 score on a scale Standard Deviation 0.5	0.83 score on a scale Standard Deviation 0.49

SECONDARY outcome

Timeframe: 1 week after operation

Post-operative stay (number of hours)

Outcome measures

Measure	PROGRIP(PG) n=22 Participants It measures the total operating time of using PROGRIP mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.	POLYPROPYLENE(PL) n=23 Participants It measures the total operating time of using POLYPROPYLENE mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.
Post-operative Stay	41.2 hours Standard Deviation 40.5	28.6 hours Standard Deviation 17.2

SECONDARY outcome

Timeframe: 1 week after operation

Post-op number of days that patient can go outdoor

Outcome measures

Measure	PROGRIP(PG) n=22 Participants It measures the total operating time of using PROGRIP mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.	POLYPROPYLENE(PL) n=23 Participants It measures the total operating time of using POLYPROPYLENE mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.
Days go Outdoor	2.5 days Standard Deviation 1.8	3.7 days Standard Deviation 2.7

SECONDARY outcome

Timeframe: 1 week after operation

Patient will be asked by assessor in out-patient clinic about satisfaction about the whole arrangement of operation. We did not intend to grade the satisfaction but simply ask whether they are satisfied. Will be either YES or NO answer.

Outcome measures

Measure	PROGRIP(PG) n=22 Participants It measures the total operating time of using PROGRIP mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.	POLYPROPYLENE(PL) n=23 Participants It measures the total operating time of using POLYPROPYLENE mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.
Number of Participants Whose Response Was YES is Reported	20 participants	23 participants

SECONDARY outcome

Timeframe: intra-operative record

Longitudinal size of mesh (in mm).

Outcome measures

Measure	PROGRIP(PG) n=22 Participants It measures the total operating time of using PROGRIP mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.	POLYPROPYLENE(PL) n=23 Participants It measures the total operating time of using POLYPROPYLENE mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.
Size of Mesh (Longitudinal)	110.7 mm Standard Deviation 7	106.7 mm Standard Deviation 8.2

SECONDARY outcome

Timeframe: intra-operative record

Vertical size of mesh (in mm).

Outcome measures

Measure	PROGRIP(PG) n=22 Participants It measures the total operating time of using PROGRIP mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.	POLYPROPYLENE(PL) n=23 Participants It measures the total operating time of using POLYPROPYLENE mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.
Size of Mesh (Vertical)	72 mm Standard Deviation 6.7	66.7 mm Standard Deviation 10

SECONDARY outcome

Timeframe: intra-operative record

Size of main wound

Outcome measures

Measure	PROGRIP(PG) n=22 Participants It measures the total operating time of using PROGRIP mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.	POLYPROPYLENE(PL) n=23 Participants It measures the total operating time of using POLYPROPYLENE mesh. it measured from time started the skin incision to time finishing wound closure in terms of minutes.
Wound Size	50.7 mm Standard Deviation 7.1	53.5 mm Standard Deviation 5.7

Adverse Events

PROGRIP

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

POLYPROPYLENE

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	PROGRIP n=22 participants at risk Use of PROGRIP mesh for open inguinal hernia repair PROGRIP: Use of PROGRIP mesh for open inguinal hernia repair	POLYPROPYLENE n=23 participants at risk Use of Polypropylene mesh for open inguinal hernia repair POLYPROPYLENE: Use of Polypropylene mesh in open inguinal hernia repair
Surgical and medical procedures Non-surgery related mortality	22.7% 5/22 • Number of events 5 • from 2-6 years after operation unexpected operation unrelated mortality, Patients died of disease other than primary disease (hernia), nor due to treatment of such disease (hernia repair), nor due to material being used (mesh)	0.00% 0/23 • from 2-6 years after operation unexpected operation unrelated mortality, Patients died of disease other than primary disease (hernia), nor due to treatment of such disease (hernia repair), nor due to material being used (mesh)

Other adverse events

Adverse event data not reported

Additional Information

Dr. Joe Fan King Man

The University of Hong Kong

Phone: 852-22553111

Email: drfanj@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place