|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02525666 |
|
Date of registration:
|
05/08/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Bilateral Laparoscopic Repair of Groin Hernias With One Large Self-fixating Mesh (ProGripTM)
BigWig |
|
Scientific title:
|
Evaluation of Bilateral Laparoscopic Repair of Groin Hernias With One Large Self-fixating Mesh (ProGripTM) in a Prospective Cohort Study |
|
Date of first enrolment:
|
August 2015 |
|
Target sample size:
|
100 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02525666 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Belgium
| | | | | | | |
|
Contacts
|
|
Name:
|
Filip Muysoms, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Algemeen Ziekenhuis Maria Middelares |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- patients scheduled for primary bilateral inguinal hernia repair
Exclusion Criteria:
- recurrent groin hernia
- open hernia repair
- unilateral hernias
- concomitant repair of another abdominal hernia e.g. umbilical hernia
- hernia repair combined with another surgical procedure
- emergency operations, like incarcerated hernias
- patients under the age of 18 years or over 80 years
- ASA score 4 or more
- patients unable to perform the QoL assessment, because of language barrier or
intellectual incapacity
- no informed consent of the patient
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Male
|
|
Health Condition(s) or Problem(s) studied
|
|
Hernia
|
|
Quality of Life
|
|
Recurrence
|
|
Primary Outcome(s)
|
|
Assessment of ICIQ-MLUTS Score
[Time Frame: 12 months]
|
|
Secondary Outcome(s)
|
|
Assessment of ICIQ-MLUTS Score
[Time Frame: preoperative, 1 month and 3 month post-operative]
|
|
Quality of Life assessment
[Time Frame: pre-operatively, 1, 3 and 12 month postoperatively]
|
|
Secondary ID(s)
|
|
BigWig Study
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|