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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06298500
Other study ID # AAG-O-H-2115
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 2024
Est. completion date September 2024

Study information

Verified date March 2024
Source Aesculap AG
Contact Oriol Estallo Sanz
Phone +34935866200
Email info@bbraun.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this retrospective study is to identify the incidence of hernia recurrence following the application of Histoacryl® Lapfix - Cannula for laparoscopic mesh fixation in patients undergoing hernia repair surgery. All adult patients who underwent laparoscopic inguinal hernia repair with Histoacryl® Lapfix - Cannula in the period June 2018 - March 2021 at Hospital San Juan de Dios will be analysed. The investigator team will access electronical medical records for the cohort of patients identified.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 448
Est. completion date September 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients (=18 years old) - treated between June 2018 and March 2021 at the Hospital San Juan de Dios for laparoscopic mesh fixation with Histoacryl Lapfix - Cannula after inguinal hernia repair surgery. Exclusion Criteria: - No exclusion criteria has been set.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
hernia repair surgery
In recent years, atraumatic mesh fixation with tissue adhesive has increasingly become the method of choice. It is the recommended mesh fixation method by the International Hernia Society Guidelines. In this study patients with inguinal hernia are treated by placing a prosthetic mesh in one of the layers of the abdominal wall to cover the weakness, the mesh is fixed by Histoacryl LapFix,

Locations

Country Name City State
Spain Hospital San Juan de Dios Santa Cruz De Tenerife Tenerife

Sponsors (2)

Lead Sponsor Collaborator
Aesculap AG B.Braun Surgical SA

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hernia recurrence rate Describe the incidence of hernia recurrence following the application of Histoacryl® LapFix - Cannula for laparoscopic mesh fixation in patients undergoing hernia repair surgery. The incidence of hernia recurrence is documented from the medical records until 6 months postoperatively. until 6 months postoperatively
Secondary Delayed tissue adhesive polymerization The polymerization time of Histoacryl® (about 30 seconds) takes longer than expected. intraoperatively
Secondary Intraoperative bleeding requiring therapeutic measures Bleeding that requires additional measures than normal practice for stopping the hemorrhage. intraoperatively
Secondary Organ injury Cumulative Number of patients suffering from Injury of an organ adjacent to the defect. intraoperatively
Secondary Hernia recurrence Cumulative Number of Hernia recurring again after repair at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
Secondary Mesh migration Cumulative Number of patients in whom Mesh has moved from its original position at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
Secondary Adhesions Cumulative Number of patients in whom tissue is adhered and allows no physiological movement at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
Secondary Erosion Cumulative Number of patients suffering from a mesh erosion into the bladder/urethra include painful voiding, urinary frequency, urgency, hematuria, recurrent urinary tract infection, urinary calculi and urinary fistula. at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
Secondary Meshoma formation Cumulative Number of patients suffering from a wrinkling of the mesh that causes pain or hernia recurrence. Nerve entrapment or damage. Rejection of the mesh implant. at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
Secondary Tack hernias Cumulative Number of patients requiring tack fixation was needed at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
Secondary Surgical Site Infection (superficial, deep, intraabdominal) Cumulative Number of patients suffering from Surgical Site Infection classified according on Center for Disease Control and Prevention criteria (A1: superficial, A2: deep, A3:
organ/space)
at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
Secondary Hematoma Cumulative Number of patients suffering from a solid swelling of clotted blood within the tissues. at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
Secondary Seroma Cumulative Number of patients suffering from a mass or lump caused by a buildup of clear fluid in a tissue, organ or body cavity at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
Secondary Hemorrhage Cumulative Number of patients suffering from an escape of blood from a ruptured blood vessel. at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
Secondary Orchitis Cumulative Number of patients suffering from inflammation of the testicles at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
Secondary Other Adverse Event Cumulative Number of any other adverse event not mentioned. at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
Secondary Reintervention Patient requiring to be operated again for any reason. until 6 months postoperatively
Secondary Mesh repositioning or removal Patient requiring being operated again for repositioning or removal of the Mesh until 6 months postoperatively
Secondary Acute or chronic pain pain persisting beyond 6 months postoperatively re-quiring analgesic treatment until 6 months postoperatively
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