Clinical trial NCT06298500: Clinical Performance of HISTOACRYL® LAPFIX - CANNULA for Laparoscopic Inguinal Hernia Repair
Official title: Retrospective, Single Center Clinical Study on the Clinical Performance of Histoacryl® Lapfix - Cannula for Laparoscopic Inguinal Hernia Repair
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inguinal Hernia
Keywords: laparoscopic mesh fixation
inguinal hernia repair surgery
Cyanoacrylate
Histoacryl®
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: B.Braun Surgical SA
First posted: 2024-03-07
Enrollment: 448
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (≥18 years old) treated in the period June 2018 to March 2021 at the Hospital San Juan de Dios for laparoscopic mesh fixation with Histoacryl Lapfix - Cannula after inguinal hernia repair surgery.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Hernia recurrence rate
timeFrame: until 6 months postoperatively
Secondary outcomes:
measure: Delayed tissue adhesive polymerization
timeFrame: intraoperatively
measure: Intraoperative bleeding requiring therapeutic measures
timeFrame: intraoperatively
measure: Organ injury
timeFrame: intraoperatively
measure: Hernia recurrence
timeFrame: at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
measure: Mesh migration
timeFrame: at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
measure: Adhesions
timeFrame: at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
measure: Erosion
timeFrame: at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
measure: Meshoma formation
timeFrame: at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
measure: Tack hernias
timeFrame: at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
measure: Surgical Site Infection (superficial, deep, intraabdominal)
timeFrame: at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
measure: Hematoma
timeFrame: at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
measure: Seroma
timeFrame: at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
measure: Hemorrhage
timeFrame: at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
measure: Orchitis
timeFrame: at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
measure: Other Adverse Event
timeFrame: at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months
measure: Reintervention
timeFrame: until 6 months postoperatively
measure: Mesh repositioning or removal
timeFrame: until 6 months postoperatively
measure: Acute or chronic pain
timeFrame: until 6 months postoperatively
Other outcomes:
Locations:
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital San Juan de Dios
state: Tenerife
Study officials:
References: