An Efficiency/Safety Study of Surgical Tissue Glue to Treat Inguinal Hernias
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|