Efficacy Study of Tissucol/Tisseel Fibrin Sealant to Treat Inguinal Hernia
Summary
The purpose of the study is to evaluate mid and long term postoperative pain and further disabling complications in open inguinal hernia repair by Lichtenstein technique after mesh fixation with fibrin sealant (FS), compared to mesh fixation with sutures.
Description
Subjects in the FS group will be operated by Lichtenstein technique, with mesh fixation by fibrin sealant. Subjects in control group will be operated with conventional Lichtenstein technique (mesh fixation by sutures).
Hernia repair will be performed according to standardized Lichtenstein technique, a technique for tension free hernioplasty. A Polypropylene, heavyweight, macroporous mesh will be used (8x15 cm) tailored to individual patients requirement. The different ways of mesh fixation will be randomly assigned within 24 hours before the operation. In the FS group, the two tails of the mesh will be fixed together in overlapping their edges and by surrounding the cord. The edges will be joined up to by 1 suture. No other sutures will be used. First the mesh will be put correctly in place. A small spot (0.5ml) of FS will be applied on the pubis under the mesh without spray then the remaining part (3,5ml) over the mesh on the entire surface in a thin uniform layer by spray. 2 ml Tissucol-Tisseel (4 ml of fibrin sealant) will be used per mesh. In the control group, the mesh will be fixed in a conventional manner. Nerve resection (if occurred) will be recorded; it should be avoided.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Inguinal Hernia
Intervention
standardized Lichtenstein technique
Location
Gasthuisberg University Hospitals KUL
Leuven
Belgium
3000
Status
Completed
Source
University of Milan
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00306839
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:45:31-0400
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Medical and Biotech [MESH] Definitions
Hernia, Inguinal
An abdominal hernia with an external bulge in the GROIN region. It can be classified by the location of herniation. Indirect inguinal hernias occur through the internal inguinal ring. Direct inguinal hernias occur through defects in the ABDOMINAL WALL (transversalis fascia) in Hesselbach's triangle. The former type is commonly seen in children and young adults; the latter in adults.
Hernia, Abdominal
A protrusion of abdominal structures through the retaining ABDOMINAL WALL. It involves two parts: an opening in the abdominal wall, and a hernia sac consisting of PERITONEUM and abdominal contents. Abdominal hernias include groin hernia (HERNIA, FEMORAL; HERNIA, INGUINAL) and VENTRAL HERNIA.
Hernia, Femoral
A groin hernia occurring inferior to the inguinal ligament and medial to the FEMORAL VEIN and FEMORAL ARTERY. The femoral hernia sac has a small neck but may enlarge considerably when it enters the subcutaneous tissue of the thigh. It is caused by defects in the ABDOMINAL WALL.
Inguinal Canal
The tunnel in the lower anterior ABDOMINAL WALL through which the SPERMATIC CORD, in the male; ROUND LIGAMENT, in the female; nerves; and vessels pass. Its internal end is at the deep inguinal ring and its external end is at the superficial inguinal ring.
Q-sort
A personality assessment technique in which the subject or observer indicates the degree to which a standardized set of descriptive statements actually describes the subject. The term reflects "sorting" procedures occasionally used with this technique.
