Ventral Hernia Clinical Trial
— LACHOfficial title:
The Effect of Mesh Fixation Technique on Postoperative Pain in Laparoscopic Correction of Incisional and Ventral Abdominal Wall Hernias.
Method of fixation of the mesh in laparoscopic incisional / ventral hernia repair might
influence the degree of postoperative pain.
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.
Status | Completed |
Enrollment | 215 |
Est. completion date | January 2009 |
Est. primary completion date | October 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Non-acute incisional hernia of the abdominal wall or ventral hernia of the abdominal wall - Informed consent - Elective surgery Exclusion Criteria: - < 18 years and > 80 years - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Ziekenhuisgroep Twente | Almelo |
Lead Sponsor | Collaborator |
---|---|
Ziekenhuisgroep Twente |
Netherlands,
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. — View Citation
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. — View Citation
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. — View Citation
LeBlanc KA. Laparoscopic incisional and ventral hernia repair: complications-how to avoid and handle. Hernia. 2004 Dec;8(4):323-31. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of postoperative pain | one year | No | |
Secondary | Quality of life | one year | No | |
Secondary | Overall satisfaction | one year | No | |
Secondary | Postoperative stay | one month | No | |
Secondary | Per- and postoperative morbidity | one month | No | |
Secondary | Recurrence | Three years | No |
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