Inguinal HerniaNCT00925067
Effects of Lightweight Meshes in Laparoscopic Inguinal Hernia Repair on Quality of Life and Male Fertility Aspects
A study testing laparoscopic (TEP) inguinal hernia repair, lightweight TiMesh and lightweight VyproII in people with Inguinal Hernia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
A randomized, prospective clinical trial analyzing whether the use of lightweight prostheses during laparoscopic inguinal hernia repair of male patients could have a beneficial effect on postoperative discomfort, chronic pain development, recurrence and male fertility aspects. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- laparoscopic (TEP) inguinal hernia repair, lightweight TiMesh and lightweight VyproII
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2003to Jun 2009
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Primary, unilateral or bilateral, inguinal hernia patients
- Informed consent
Who cannot join
- Sterilized patients
Trial locations and contacts
1 site in 1 country.
About this study
A randomized, prospective clinical trial analyzing whether the use of lightweight prostheses during laparoscopic inguinal hernia repair of male patients could have a beneficial effect on postoperative discomfort, chronic pain development, recurrence and male fertility aspects.
- Conditions
- Inguinal Hernia
- Being tested
- laparoscopic (TEP) inguinal hernia repair, lightweight TiMesh, lightweight VyproII, Heavyweight Marlex
- Keywords
- Inguinal hernia, Laparoscopic repair, Prostheses, Male fertility
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic (TEP) inguinal hernia repairProcedure or surgery
laparoscopic inguinal hernia repair with a standard heavyweight Marlex (control group) prosthesis or new generation lightweight VyproII and TiMesh prostheses (study group)
lightweight TiMeshDevice
lightweight VyproIIDevice
Heavyweight MarlexDevice
| Study group | Role | What they receive |
|---|---|---|
| lightweight TiMesh | Experimental | Not described Receives: Procedure: laparoscopic (TEP) inguinal hernia repair; Device: lightweight TiMesh |
| lightweight VyproII | Experimental | Not described Receives: Procedure: laparoscopic (TEP) inguinal hernia repair; Device: lightweight VyproII |
| Heavyweight Marlex | Experimental | Not described Receives: Procedure: laparoscopic (TEP) inguinal hernia repair; Device: Heavyweight Marlex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Male fertility aspects
Measured: 12 months
Secondary outcomes (1)
Quality of life, pain development, recurrence
Measured: 1, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2009 (estimated)
- Study startApr 2003
- Primary completionOct 2007
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium, Agentschap voor Innovatie door Wetenschap en Technologie
- Investigators
- Marc Miserez, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925067
- Sponsor's protocol ID
- G.0457.04N
- Status last verified
- Jun 2009
- First submitted
- 18 Jun 2009
- Last updated
- 19 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Peeters E, Spiessens C, Oyen R, De Wever L, Vanderschueren D, Penninckx F, Miserez M. Laparoscopic inguinal hernia repair in men with lightweight meshes may significantly impair sperm motility: a randomized controlled trial. Ann Surg. 2010 Aug;252(2):240-6. doi: 10.1097/SLA.0b013e3181e8fac5.
PubMed 20622657