Clinical Performance of HISTOACRYL® LAPFIX - CANNULA for Laparoscopic Inguinal Hernia Repair

Recruiting

• Conditions: Inguinal Hernia
• Interventions: Device: hernia repair surgery

• Registration Number: NCT06298500
• Lead Sponsor: Aesculap AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-01
• Study First Submitted QC: 2024-03-01
• Study First Posted: 2024-03-07
• Study Start: 2024-03-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-01-31
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 448

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Histoacryl Lapfix	hernia repair surgery	Histoacryl Lapfix - Cannula for laparoscopic mesh fixation in patients undergoing hernia repair surgery

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Delayed tissue adhesive polymerization	intraoperatively	The polymerization time of Histoacryl® (about 30 seconds) takes longer than expected.
Organ injury	intraoperatively	Cumulative Number of patients suffering from Injury of an organ adjacent to the defect.
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
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.
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
Mesh repositioning or removal	until 6 months postoperatively	Patient requiring being operated again for repositioning or removal of the Mesh
Intraoperative bleeding requiring therapeutic measures	intraoperatively	Bleeding that requires additional measures than normal practice for stopping the hemorrhage.
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.
Reintervention	until 6 months postoperatively	Patient requiring to be operated again for any reason.
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
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
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)
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
Acute or chronic pain	until 6 months postoperatively	pain persisting beyond 6 months postoperatively re-quiring analgesic treatment
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
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.
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.

Trial Locations

Locations (1)

Hospital San Juan de Dios; 🇪🇸 Santa Cruz De Tenerife, Tenerife, Spain