Trial Outcomes & Findings for Study Evaluating the Impact of Mesh Pore Size on Chronic Pain After Lichtenstein Hernioplasty (NCT NCT02500056)
NCT ID: NCT02500056
Last Updated: 2017-07-11
Results Overview
On visual analogue scale pain measurement at rest, on coughing, when rising from lying to sitting and during physical effort and exercise
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
143 participants
Primary outcome timeframe
6-month follow-up
Results posted on
2017-07-11
Participant Flow
Participant milestones
| Measure |
OM Group
Optilene LP mesh
Optilene LP mesh: Lichtenstein hernioplasty
|
UM Group
Ultrapro mesh
Ultrapro mesh: Lichtenstein hernioplasty
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
73
|
|
Overall Study
COMPLETED
|
63
|
65
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
Reasons for withdrawal
| Measure |
OM Group
Optilene LP mesh
Optilene LP mesh: Lichtenstein hernioplasty
|
UM Group
Ultrapro mesh
Ultrapro mesh: Lichtenstein hernioplasty
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
7
|
|
Overall Study
Recurrence
|
1
|
0
|
|
Overall Study
Death
|
3
|
1
|
Baseline Characteristics
Study Evaluating the Impact of Mesh Pore Size on Chronic Pain After Lichtenstein Hernioplasty
Baseline characteristics by cohort
| Measure |
OM Group
n=63 Participants
Optilene LP mesh
Optilene LP mesh: Lichtenstein hernioplasty
|
UM Group
n=65 Participants
Ultrapro mesh
Ultrapro mesh: Lichtenstein hernioplasty
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
>=18 years
|
63 participants
n=99 Participants
|
65 participants
n=107 Participants
|
128 participants
n=206 Participants
|
|
Sex/Gender, Customized
Female
|
3 participants
n=99 Participants
|
10 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Sex/Gender, Customized
Male
|
60 participants
n=99 Participants
|
55 participants
n=107 Participants
|
115 participants
n=206 Participants
|
|
Unilateral inguinal hernia
|
63 participants
n=99 Participants
|
65 participants
n=107 Participants
|
128 participants
n=206 Participants
|
|
Primary inguinal hernia
|
63 participants
n=99 Participants
|
65 participants
n=107 Participants
|
128 participants
n=206 Participants
|
|
Reducible inguinal hernia
|
63 participants
n=99 Participants
|
65 participants
n=107 Participants
|
128 participants
n=206 Participants
|
|
Elective operation
|
63 participants
n=99 Participants
|
65 participants
n=107 Participants
|
128 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6-month follow-upOn visual analogue scale pain measurement at rest, on coughing, when rising from lying to sitting and during physical effort and exercise
Outcome measures
| Measure |
OM Group
n=67 Participants
Optilene LP mesh
Optilene LP mesh: Lichtenstein hernioplasty
|
UM Group
n=67 Participants
Ultrapro mesh
Ultrapro mesh: Lichtenstein hernioplasty
|
|---|---|---|
|
Chronic Pain
|
34.3 percentage of patients with pain
|
46.3 percentage of patients with pain
|
SECONDARY outcome
Timeframe: 3-year follow-upOn visual analogue scale pain measurement at rest, on coughing, when rising from lying to sitting and during physical effort and exercise
Outcome measures
| Measure |
OM Group
n=63 Participants
Optilene LP mesh
Optilene LP mesh: Lichtenstein hernioplasty
|
UM Group
n=65 Participants
Ultrapro mesh
Ultrapro mesh: Lichtenstein hernioplasty
|
|---|---|---|
|
Chronic Pain
|
15.9 percentage of patients with pain
|
33.9 percentage of patients with pain
|
SECONDARY outcome
Timeframe: 6-month follow-upPopulation: Drop-outs at 6-month follow-up (3+6) not included
The question about foreign body feeling was a yes-or-no question
Outcome measures
| Measure |
OM Group
n=67 Participants
Optilene LP mesh
Optilene LP mesh: Lichtenstein hernioplasty
|
UM Group
n=67 Participants
Ultrapro mesh
Ultrapro mesh: Lichtenstein hernioplasty
|
|---|---|---|
|
Foreign Body Feeling
|
31.3 percentage of patients with foreign body
|
47.8 percentage of patients with foreign body
|
Adverse Events
OM Group
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
UM Group
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
OM Group
n=63 participants at risk
Optilene LP mesh
Optilene LP mesh: Lichtenstein hernioplasty
|
UM Group
n=65 participants at risk
Ultrapro mesh
Ultrapro mesh: Lichtenstein hernioplasty
|
|---|---|---|
|
Surgical and medical procedures
Seroma
|
3.2%
2/63 • Number of events 2 • 3-year
|
1.5%
1/65 • Number of events 1 • 3-year
|
|
Surgical and medical procedures
Haematoma
|
12.7%
8/63 • Number of events 8 • 3-year
|
13.8%
9/65 • Number of events 9 • 3-year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place