Abdominal HerniaPhase 4HSS-AHSNCT01018524
Open Mesh Versus Suture Repair in Treatment of Abdominal Wall Hernias
A Phase 4 study testing abdominal wall reconstruction in people with Abdominal Hernia, run by Hungarian Surgical Society at 1 site in Hungary.
Trial summary
The purpose of this study is to: 1. compare the long term results of mesh versus suture repair in treatment of abdominal wall defects; 2. find the optimal location of implanted prosthesis, comparing the two most useful position of mesh in abdominal wall hernia surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Abdominal Hernia
- What is being tested?
- abdominal wall reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteHungary
- Study dates
- Mar 2002to Mar 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- During the two-year randomization period at the joined centres all patients were included who were admitted with abdominal wall or umbilical hernia and who suited the requirements.
- All the patients with primer or first recurrence of postoperative abdominal or primer or first recurrence of umbilical hernia were randomized into this study.
- For involvement into the study good patient compliance, signed consent form, normal local circumstances were needed.
Who cannot join
- Ages fewer than 18 or above 70 years
- Hernia orifice under 5 cm2.
- Planned or accidental intraoperative opening of any bowel.
- Unstable parameters of circulation, uncontrollable diabetic or autoimmune disease.
- Severe renal or hepatic failure
- Advanced stage of tumours or currently treated malignancies.
- Inflamed or muddy content of hernia sac.
- If the patient did not signed the consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Results of Open Mesh Versus Suture Repair in Treatment of Abdominal Wall (Multicentric, Prospective, Randomised, Internet-based, Clinical Trial)
The purpose of this study is to:
- compare the long term results of mesh versus suture repair in treatment of abdominal wall defects;
- find the optimal location of implanted prosthesis, comparing the two most useful position of mesh in abdominal wall hernia surgery.
Read the detailed description
To determine difference of operation time, applied materials of hernia operations; clinical complications, postoperative pain, hernia recurrence, recovery and normal activity time after surgery.
- Conditions
- Abdominal Hernia
- Being tested
- abdominal wall reconstruction
- Keywords
- position of the mesh, recurrence rate, surgical procedure, long time outcome
- Medical subject headings
- Hernia, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abdominal wall reconstructionProcedure or surgery
suture repair, mesh repair, onlay mesh reconstruction, sublay mesh reconstruction, recurrence rate
| Study group | Role | What they receive |
|---|---|---|
| small hernias - suture repair | Active comparator | Not described Receives: Procedure: abdominal wall reconstruction |
| small hernias - mesh repair | Active comparator | Not described Receives: Procedure: abdominal wall reconstruction |
| large hernias - sublay mesh | Active comparator | Not described Receives: Procedure: abdominal wall reconstruction |
| large hernias - onlay mesh | Active comparator | Not described Receives: Procedure: abdominal wall reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence rate after hernia surgery
Measured: 5 years
Secondary outcomes (2)
chronic pain after hernia surgery
Measured: more one year
complications after hernia surgery
Measured: 0-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study startMar 2002
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Abdominal HerniaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hungarian Surgical Society
- Sponsor type
- Research network
- Investigators
- György Wéber, Prof. Dr., Principal investigator, Hungarian Surgical SocietyJózsef Baracs, Dr., Study director, Hungarian Surgical Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018524
- Sponsor's protocol ID
- HSS-AHS 02-09
- Acronym
- HSS-AHS
- Status last verified
- Mar 2010
- First submitted
- 13 Oct 2009
- Last updated
- 9 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Weber G, Horvath OP. [Results of ventral hernia repair: comparison of suture repair with mesh implantation (onlay vs sublay) using open and laparoscopic approach--prospective, randomized, multicenter study]. Magy Seb. 2002 Oct;55(5):285-9. Hungarian.
PubMed 12474512Weber G, Baracs J, Horvath OP. ["Onlay" mesh provides significantly better results than "sublay" reconstruction. Prospective randomized multicenter study of abdominal wall reconstruction with sutures only, or with surgical mesh--results of a five-years follow-up]. Magy Seb. 2010 Oct;63(5):302-11. doi: 10.1556/MaSeb.63.2010.5.3. Hungarian.
PubMed 20965863
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of Open Mesh Versus Suture Repair in Treatment of Abdominal Wall (Multicentric, Prospective, Randomised, Internet-based, Clinical Trial)
- ClinicalTrials.gov ID
- NCT01018524
- Acronym / sponsor ID
- HSS-AHS / HSS-AHS 02-09
- Conditions
- Abdominal Hernia
- Keywords
- position of the mesh, recurrence rate, surgical procedure, long time outcome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Hungarian Surgical SocietyResearch network
- Study start
- Mar 2002
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 23 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to:
- compare the long term results of mesh versus suture repair in treatment of abdominal wall defects;
- find the optimal location of implanted prosthesis, comparing the two most useful position of mesh in abdominal wall hernia surgery.
Detailed description
To determine difference of operation time, applied materials of hernia operations; clinical complications, postoperative pain, hernia recurrence, recovery and normal activity time after surgery.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| small hernias - suture repair | Active comparator | Procedure: abdominal wall reconstruction |
| small hernias - mesh repair | Active comparator | Procedure: abdominal wall reconstruction |
| large hernias - sublay mesh | Active comparator | Procedure: abdominal wall reconstruction |
| large hernias - onlay mesh | Active comparator | Procedure: abdominal wall reconstruction |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- During the two-year randomization period at the joined centres all patients were included who were admitted with abdominal wall or umbilical hernia and who suited the requirements.
- All the patients with primer or first recurrence of postoperative abdominal or primer or first recurrence of umbilical hernia were randomized into this study.
- For involvement into the study good patient compliance, signed consent form, normal local circumstances were needed.
Key exclusion criteria (8 listed)
- Ages fewer than 18 or above 70 years
- Hernia orifice under 5 cm2.
- Planned or accidental intraoperative opening of any bowel.
- Unstable parameters of circulation, uncontrollable diabetic or autoimmune disease.
- Severe renal or hepatic failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| abdominal wall reconstructionsuture repair, mesh repair, onlay mesh reconstruction, sublay mesh reconstruction, recurrence rate | Procedure or surgery | large hernias - onlay mesh, large hernias - sublay mesh, small hernias - mesh repair, small hernias - suture repair |
Primary outcome
recurrence rate after hernia surgery
Time frame: 5 years
2 secondary outcomes
chronic pain after hernia surgery
Time frame: more one year
complications after hernia surgery
Time frame: 0-5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2010.
- Background: PubMed 12474512Weber G, Horvath OP. [Results of ventral hernia repair: comparison of suture repair with mesh implantation (onlay vs sublay) using open and laparoscopic approach--prospective, randomized, multicenter study]. Magy Seb. 2002 Oct;55(5):285-9. Hungarian.
- Derived from this study: PubMed 20965863Weber G, Baracs J, Horvath OP. ["Onlay" mesh provides significantly better results than "sublay" reconstruction. Prospective randomized multicenter study of abdominal wall reconstruction with sutures only, or with surgical mesh--results of a five-years follow-up]. Magy Seb. 2010 Oct;63(5):302-11. doi: 10.1556/MaSeb.63.2010.5.3. Hungarian.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
György Wéber, Prof. Dr. principal investigator
Hungarian Surgical Society
József Baracs, Dr. study director
Hungarian Surgical Society
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing abdominal wall reconstruction in people with Abdominal Hernia, run by Hungarian Surgical Society at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence rate after hernia surgery (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01018524, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2010.