Laparoscopic or Conventional Mesh Repair of Incisional and Umbilical Hernia
NCT ID: NCT00970515
Last Updated: 2021-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
98 participants
INTERVENTIONAL
2009-11-30
2013-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prospective Evaluation of Laparoscopic and Open Incisional Hernia Repair: a Multicenter Cohort Study
NCT01280370
A Study to Compare Ventral Incisional Hernia by Laparoscopic vs Open Repair With Mesh
NCT00240188
Laparoscopic Versus Open Incisional Hernia Repair
NCT01420757
Comparison of Hybrid and Laparoscopic Incisional Hernia Repair
NCT02542085
Comparative Study Matching Intraperitoneal Onlay Mesh (IPOM) and Sublay Mesh to Treat Umbilical Hernia
NCT01201564
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Laparoscopic approach
group A: Laparoscopic approach
Laparoscopic mesh hernia repair
The mesh is intraperitoneal
Open approach
group B: Open anterior approach
Open anterior approach
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Laparoscopic mesh hernia repair
The mesh is intraperitoneal
Open anterior approach
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Incisional or umbilical hernia over 2 cm and less than 6 cm in diameter
Exclusion Criteria
* 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)
* 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
18 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Corinne Ms Vons, MD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hôpital Jean Verdier, department of digestive and general surgery
Bondy, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Vons 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.
Proske 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2007-A00374-49
Identifier Type: OTHER
Identifier Source: secondary_id
K060214
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.