An Efficiency/Safety Study of Surgical Tissue Glue to Treat Inguinal Hernias
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|ClinicalTrials.gov Identifier: NCT01669837|
Recruitment Status : Recruiting
First Posted : August 21, 2012
Last Update Posted : November 6, 2017
|Condition or disease||Intervention/treatment|
|Inguinal Hernia||Device: Mesh fixation with surgical tissue glue|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Cyanoacrylate Fixation for Laparoscopic Repair of Inguinal Hernias: a Prospective, Multicenter Registry|
|Study Start Date :||March 2012|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||December 2019|
Administration of surgical tissue glue.
Device: Mesh fixation with surgical tissue glue
Laparoscopic inguinal hernia repair using surgical tissue glue for mesh fixation
- Postoperative pain [ Time Frame: up to 1 year ]Prevalence of postoperative pain evaluated by patient self-assessment using a visual analog scale.
- Intraoperative complications [ Time Frame: 1 day ]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 ]Local numbness, hematoma, seroma, wound infection, mesh infection, hernia recurrence.
- Analgesic intake [ Time Frame: Discharge, 5 weeks ]Intake of analgesics.
- Quality of life (QOL) [ Time Frame: Preoperative, 5 weeks, 1 year ]QOL assessed by EQ-5D questionnaire.
- Freedom from hernia-related reinterventions [ Time Frame: 1 year ]Reinterventions at 1 year after index-procedure assessed by means of a questionnaire.
- Late complications [ Time Frame: 1 year ]Local numbness, groin discomfort, hernia recurrence, sexual dysfunction
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669837
|Contact: Dorien Haesenfirstname.lastname@example.org|
|Contact: Kurt Van der Speeten, MDemail@example.com|
|Genk, Limburg, Belgium, 3600|
|Contact: Kurt Van der Speeten, MD 003289325050 firstname.lastname@example.org|
|Principal Investigator: Joost Vankeirsbilck, MD|
|Principal Investigator: Luc Berwouts, MD|
|Principal Investigator: Nele Van de Winkel, MD|
|Principal Investigator: Anthony Beunis, MD|
|Principal Investigator:||Kurt Van der Speeten, MD||Ziekenhuis Oost-Limburg|