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.
COMPLETED
NA
215 participants
INTERVENTIONAL
2005-08-31
2009-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The study hypothesis is that there is no difference in postoperative pain between different methods to fix the mesh in laparoscopic incisional / ventral hernia repair.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Influence of Closing the Gap on Postoperative Seroma and Recurrences in Laparoscopic Ventral Hernia Repair
NCT01719718
Laparoscopic Ventral Hernia Repair by Heavy Weight or Lighter Weight Mesh (COMPOSIX-trial)
NCT00573105
Transfacial Sutures Versus Stapler for Mesh Fixation in Laparoscopic Ventral Hernia Repair
NCT00773851
Laparoscopic Versus Open Incisional Hernia Repair
NCT01420757
Tacks Versus Glue for Mesh Fixation in Laparoscopic Ventral Hernia Repair Treating Defects Between 2 and 5 cm Width
NCT03429374
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study hypothesis is that there is no difference in postoperative pain when comparing three commonly used mesh fixation techniques in laparoscopic incisional / ventral hernia repair.
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
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
0
fixation of mesh with a single crown of tacks and absorbable sutures
laparoscopic correction of hernia with mesh
Correction of hernia with mesh and fixation of mesh using one of the arms.
1
fixation of mesh with a double crown of tacks and no sutures
laparoscopic correction of hernia with mesh
Correction of hernia with mesh and fixation of mesh using one of the arms.
2
fixation of mesh with a single crown of tacks and non-absorbable sutures
laparoscopic correction of hernia with mesh
Correction of hernia with mesh and fixation of mesh using one of the arms.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
laparoscopic correction of hernia with mesh
Correction of hernia with mesh and fixation of mesh using one of the arms.
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
* Informed consent
* Elective surgery
Exclusion Criteria
* Prednison \> 15 mg/24hr, started more than 2 weeks prior to surgery
* Chronical cough (severe COPD etc)
* Ascites
* Peritoneal dialysis
* Current abdominal infection
* Complete loss of abdominal domain due to hernia (diameter more than 10 cm?)
* Re-laparoscopic correction of ventral hernia
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ziekenhuisgroep Twente
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ziekenhuisgroep Twente
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Eelco B Wassenaar, MD
Role: PRINCIPAL_INVESTIGATOR
Ziekenhuisgroep Twente
Srjdan Rakic, MD, PhD
Role: STUDY_DIRECTOR
Ziekenhuisgroep Twente
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ziekenhuisgroep Twente
Almelo, , Netherlands
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.
Goodney PP, Birkmeyer CM, Birkmeyer JD. Short-term outcomes of laparoscopic and open ventral hernia repair: a meta-analysis. Arch Surg. 2002 Oct;137(10):1161-5. doi: 10.1001/archsurg.137.10.1161.
DeMaria EJ, Moss JM, Sugerman HJ. Laparoscopic intraperitoneal polytetrafluoroethylene (PTFE) prosthetic patch repair of ventral hernia. Prospective comparison to open prefascial polypropylene mesh repair. Surg Endosc. 2000 Apr;14(4):326-9. doi: 10.1007/s004640020013.
LeBlanc KA. Laparoscopic incisional and ventral hernia repair: complications-how to avoid and handle. Hernia. 2004 Dec;8(4):323-31. doi: 10.1007/s10029-004-0250-5.
Heniford BT, Park A, Ramshaw BJ, Voeller G. Laparoscopic repair of ventral hernias: nine years' experience with 850 consecutive hernias. Ann Surg. 2003 Sep;238(3):391-9; discussion 399-400. doi: 10.1097/01.sla.0000086662.49499.ab.
Wassenaar E, Schoenmaeckers E, Raymakers J, van der Palen J, Rakic S. Mesh-fixation method and pain and quality of life after laparoscopic ventral or incisional hernia repair: a randomized trial of three fixation techniques. Surg Endosc. 2010 Jun;24(6):1296-302. doi: 10.1007/s00464-009-0763-1. Epub 2009 Dec 24.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
P05-28
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.