An Efficiency/Safety Study of Surgical Tissue Glue to Treat Inguinal Hernias
Prospective, multicenter, observational registry to collect data of laparoscopic inguinal hernia repair using surgical tissue glue fixation. The objective is to determine the prevalence of chronic pain at 1 year.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Cyanoacrylate Fixation for Laparoscopic Repair of Inguinal Hernias: a Prospective, Multicenter Registry|
- Postoperative pain [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]Prevalence of postoperative pain evaluated by patient self-assessment using a visual analog scale.
- Intraoperative complications [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]Complications such as bowel injury, major bleeding, complications due to anesthesia, nerve damage, lesion of vas deferens.
- Postoperative complications [ Time Frame: Up to 30 days after index-procedure ] [ Designated as safety issue: Yes ]Local numbness, hematoma, seroma, wound infection, mesh infection, hernia recurrence.
- Analgesic intake [ Time Frame: Discharge, 5 weeks ] [ Designated as safety issue: No ]Intake of analgesics.
- Quality of life (QOL) [ Time Frame: Preoperative, 5 weeks, 1 year ] [ Designated as safety issue: No ]QOL assessed by EQ-5D questionnaire.
- Freedom from hernia-related reinterventions [ Time Frame: 1 year ] [ Designated as safety issue: No ]Reinterventions at 1 year after index-procedure assessed by means of a questionnaire.
- Late complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Local numbness, groin discomfort, hernia recurrence, sexual dysfunction
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Administration of surgical tissue glue.
Device: Mesh fixation with surgical tissue glue
Laparoscopic inguinal hernia repair using surgical tissue glue for mesh fixation
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669837
|Contact: Kurt Van der Speeten, MDfirstname.lastname@example.org|
|Genk, Limburg, Belgium, 3600|
|Contact: Kurt Van der Speeten, MD 003289325050 email@example.com|
|Principal Investigator:||Kurt Van der Speeten, MD||Ziekenhuis Oost-Limburg|