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

Inguinal Hernia Clinical Trial

— HISTOLAP  

Official title:

Retrospective, Single Center Clinical Study on the Clinical Performance of Histoacryl® Lapfix - Cannula for Laparoscopic Inguinal Hernia Repair

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06298500
• Other study ID #: AAG-O-H-2115
• Status: Not yet recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

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