Inguinal Hernia
Conditions
Keywords
laparoscopic mesh fixation, inguinal hernia repair surgery, Cyanoacrylate, Histoacryl®
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.
Interventions
DEVICEhernia 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,
Sponsors
B.Braun Surgical SA
Aesculap AG
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hernia recurrence rate | until 6 months postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative bleeding requiring therapeutic measures | intraoperatively | Bleeding that requires additional measures than normal practice for stopping the hemorrhage. |
| Organ injury | intraoperatively | Cumulative Number of patients suffering from Injury of an organ adjacent to the defect. |
| Hernia recurrence | at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months | Cumulative Number of Hernia recurring again after repair |
| Mesh migration | at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months | Cumulative Number of patients in whom Mesh has moved from its original position |
| Adhesions | at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months | Cumulative Number of patients in whom tissue is adhered and allows no physiological movement |
| Erosion | at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months | 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. |
| Meshoma formation | at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months | 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. |
| Tack hernias | at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months | Cumulative Number of patients requiring tack fixation was needed |
| Delayed tissue adhesive polymerization | intraoperatively | The polymerization time of Histoacryl® (about 30 seconds) takes longer than expected. |
| Hematoma | at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months | Cumulative Number of patients suffering from a solid swelling of clotted blood within the tissues. |
| Seroma | at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months | Cumulative Number of patients suffering from a mass or lump caused by a buildup of clear fluid in a tissue, organ or body cavity |
| Hemorrhage | at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months | Cumulative Number of patients suffering from an escape of blood from a ruptured blood vessel. |
| Orchitis | at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months | Cumulative Number of patients suffering from inflammation of the testicles |
| Other Adverse Event | at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months | Cumulative Number of any other adverse event not mentioned. |
| Reintervention | until 6 months postoperatively | Patient requiring to be operated again for any reason. |
| Mesh repositioning or removal | until 6 months postoperatively | Patient requiring being operated again for repositioning or removal of the Mesh |
| Acute or chronic pain | until 6 months postoperatively | pain persisting beyond 6 months postoperatively re-quiring analgesic treatment |
| Surgical Site Infection (superficial, deep, intraabdominal) | at discharge and 1 month postoperatively. There is the possibility to extend the follow-up period until 6 months | 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) |
Countries
Spain
Outcome results
None listed