Incisional HerniaEVENTRALAPNCT00970515
Laparoscopic or Conventional Mesh Repair of Incisional and Umbilical Hernia
A study testing Laparoscopic mesh hernia repair and Open anterior approach in people with Incisional Hernia and Umbilical Hernia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of this study is to compare immediate and long-term (24 months) results of laparoscopic and open mesh repair of incisional and umbilical hernia. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Incisional Hernia, Umbilical Hernia
- What is being tested?
- Laparoscopic mesh hernia repair and Open anterior approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2009to Apr 2013
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18
- Incisional or umbilical hernia over 2 cm and less than 6 cm in diameter
Who cannot join
- Patients with a complicated incisional (pain, occlusion, cutaneous necrosis), irreductible painless incisional or umbilical hernia will not be considered as a complication
- Patients with a recurrence of incisional hernia
- Patients with an incisional or umbilical hernia whose lateral edges are located so that fixation of the mesh (which must extend beyond the 4 to 5 cm) is not possible
- Pregnant women
- Patients with HIV therapy
- Patients with cirrhotic ascites or other signs of hepatic insufficiency (bilirubin> 35 micromol / l; TP < 55%) or significant thrombocytopenia (< 60 000 platelets)
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- Patients with a contra indication for laparoscopy
- Patients with a life expectancy < one year, or whose mobility within two years of treatment will damage proper monitoring
- Patients unable to understand information about the protocol
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Jean Verdier, department of digestive and general surgery
Bondy, 93140
About this study
Official title: A Prospective, Multicenter, Randomized Trial Comparing Laparoscopy VS Conventional Mesh Repair of Incisional and Umbilical Hernia
The aim of this study is to compare immediate and long-term (24 months) results of laparoscopic and open mesh repair of incisional and umbilical hernia.
Read the detailed description
The aim of this study is to compare immediate and long-term (24 months) results of laparoscopic and open mesh repair of incisional and umbilical hernia.
Five hundred patients will be included in this randomized, multicentric trial.
Hypotheses are that laparoscopic approach: 1- reduces immediate parietal complications without increasing intra abdominal septic complications 2- is less invasive and also reduces patients' hospital stay and recovery time; 3- has the same efficacy, than open approach.
- Conditions
- Incisional Hernia, Umbilical Hernia
- Being tested
- Laparoscopic mesh hernia repair, Open anterior approach
- Keywords
- Laparoscopy, Incisional hernia, Umbilical hernia, Mesh repair, Postoperative complications
- Medical subject headings
- Incisional Hernia, Hernia, Umbilical, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic mesh hernia repairProcedure or surgery
Also called laparoscpic mesh repair of incisional and umbilical hernia
The mesh is intraperitoneal
Open anterior approachProcedure or surgery
Also called Conventional treatment of incisional and umbilical hernia
The mesh is placed by an anterior approach. It is placed after incision of the skin over or under the abdominal muscles, or is intraperitoneal
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic approach | Experimental | group A: Laparoscopic approach Receives: Procedure: Laparoscopic mesh hernia repair |
| Open approach | Active comparator | group B: Open anterior approach Receives: Procedure: Open anterior approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parietal postoperative complications: 1- haematoma, 2- abscess, 3- seroma 4- cutaneous necrosis
Measured: 2 months
Postoperative intra abdominal complications: peritonitis, occlusion, haemorrhage
Measured: 2 months
Secondary outcomes (13)
Postoperative pain: measured by a- Visual Analogic Score (VAS 0-10): 1-number of days with VAS > 5; 2- maximal VAS, and b- duration (days) of morphine use
Measured: 2 months
Postoperative fever > 38°5
Measured: 2 months
Postoperative ileus
Measured: 2 months
Postoperative phlebitis
Measured: 2 months
Postoperative pulmonary embolism
Measured: 2 months
Postoperative urinary infection
Measured: 2 months
Duration of hospital stay
Measured: 2 months
Duration of drainage
Measured: 2 months
Mesh infection
Measured: 24 months
Peritonitis due to intraperitoneal mesh
Measured: 24 months
Occlusion due to intra peritoneal mesh
Measured: 2 months
Recurrence of incisional or umbilical hernia
Measured: 24 months
Trocar site hernia
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startNov 2009
- Primary completionApr 2011
- Study completionApr 2013
Why it stopped: lack of recrutment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Incisional HerniaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Corinne Ms Vons, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970515
- Sponsor's protocol ID
- K060214
- Other IDs
- 2007-A00374-49
- Acronym
- EVENTRALAP
- Status last verified
- Jun 2021
- First submitted
- 1 Sep 2009
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Slim K, Vons C. [Inguinal hernia repair: results of randomized clinical trials and meta-analyses]. J Chir (Paris). 2008 Mar-Apr;145(2):122-5. doi: 10.1016/s0021-7697(08)73720-7. French.
PubMed 18645551Vons C. [Laparoscopic treatment of ventral hernias]. J Chir (Paris). 2004 Nov;141(6):366-70. doi: 10.1016/s0021-7697(04)95361-6. No abstract available. French.
PubMed 15738845Proske JM, Vons C. [Laparoscopic treatment of ventral hernias]. J Chir (Paris). 2004 Nov;141(6):360-4. doi: 10.1016/s0021-7697(04)95360-4. French.
PubMed 15738844
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Trial Comparing Laparoscopy VS Conventional Mesh Repair of Incisional and Umbilical Hernia
- ClinicalTrials.gov ID
- NCT00970515
- Acronym / sponsor ID
- EVENTRALAP / K060214
- Conditions
- Incisional Hernia, Umbilical Hernia
- Keywords
- Laparoscopy, Incisional hernia, Umbilical hernia, Mesh repair, Postoperative complications
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of recrutment
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Nov 2009 (actual)
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 2 Sep 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 aim of this study is to compare immediate and long-term (24 months) results of laparoscopic and open mesh repair of incisional and umbilical hernia.
Detailed description
The aim of this study is to compare immediate and long-term (24 months) results of laparoscopic and open mesh repair of incisional and umbilical hernia.
Five hundred patients will be included in this randomized, multicentric trial.
Hypotheses are that laparoscopic approach: 1- reduces immediate parietal complications without increasing intra abdominal septic complications 2- is less invasive and also reduces patients' hospital stay and recovery time; 3- has the same efficacy, than open approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic approach | Experimental | Procedure: Laparoscopic mesh hernia repairgroup A: Laparoscopic approach |
| Open approach | Active comparator | Procedure: Open anterior approachgroup B: Open anterior approach |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18
- Incisional or umbilical hernia over 2 cm and less than 6 cm in diameter
Key exclusion criteria (9 listed)
- Patients with a complicated incisional (pain, occlusion, cutaneous necrosis), irreductible painless incisional or umbilical hernia will not be considered as a complication
- Patients with a recurrence of incisional hernia
- Patients with an incisional or umbilical hernia whose lateral edges are located so that fixation of the mesh (which must extend beyond the 4 to 5 cm) is not possible
- Pregnant women
- Patients with HIV therapy
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 |
|---|---|---|
| Laparoscopic mesh hernia repairAlso: laparoscpic mesh repair of incisional and umbilical herniaThe mesh is intraperitoneal | Procedure or surgery | Laparoscopic approach |
| Open anterior approachAlso: Conventional treatment of incisional and umbilical herniaThe mesh is placed by an anterior approach. It is placed after incision of the skin over or under the abdominal muscles, or is intraperitoneal | Procedure or surgery | Open approach |
Primary outcome
Parietal postoperative complications: 1- haematoma, 2- abscess, 3- seroma 4- cutaneous necrosis
Time frame: 2 months
Postoperative intra abdominal complications: peritonitis, occlusion, haemorrhage
Time frame: 2 months
13 secondary outcomes
Postoperative pain: measured by a- Visual Analogic Score (VAS 0-10): 1-number of days with VAS > 5; 2- maximal VAS, and b- duration (days) of morphine use
Time frame: 2 months
Postoperative fever > 38°5
Time frame: 2 months
Postoperative ileus
Time frame: 2 months
Postoperative phlebitis
Time frame: 2 months
Postoperative pulmonary embolism
Time frame: 2 months
Postoperative urinary infection
Time frame: 2 months
Duration of hospital stay
Time frame: 2 months
Duration of drainage
Time frame: 2 months
Mesh infection
Time frame: 24 months
Peritonitis due to intraperitoneal mesh
Time frame: 24 months
Occlusion due to intra peritoneal mesh
Time frame: 2 months
Recurrence of incisional or umbilical hernia
Time frame: 24 months
Trocar site hernia
Time frame: 24 months
Results and safety
The study was stopped early (reason given: lack of recrutment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Background: PubMed 18645551Slim K, Vons C. [Inguinal hernia repair: results of randomized clinical trials and meta-analyses]. J Chir (Paris). 2008 Mar-Apr;145(2):122-5. doi: 10.1016/s0021-7697(08)73720-7. French.
- Background: PubMed 15738845Vons C. [Laparoscopic treatment of ventral hernias]. J Chir (Paris). 2004 Nov;141(6):366-70. doi: 10.1016/s0021-7697(04)95361-6. No abstract available. French.
- Background: PubMed 15738844Proske JM, Vons C. [Laparoscopic treatment of ventral hernias]. J Chir (Paris). 2004 Nov;141(6):360-4. doi: 10.1016/s0021-7697(04)95360-4. French.
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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.
Corinne Ms Vons, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic mesh hernia repair and Open anterior approach in people with Incisional Hernia and Umbilical Hernia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 2 inclusion and 9 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: stopped early, as of the sponsor's last update on 18 Jun 2021. 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 France. 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.
Are results available for this study?
The study was stopped early (reason given: lack of recrutment). Results are not available in the source record.
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?
Parietal postoperative complications: 1- haematoma, 2- abscess, 3- seroma 4- cutaneous necrosis (time frame: 2 months). The study lists 2 primary outcomes in all. 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 NCT00970515, which also lists 3 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 18 Jun 2021.