The Use of Ligasure (r) for Hydrocelectomy Surgery

Hydrocele Clinical Trial

Official title:

The Use of Ligasure (r) for Cutting and Coagulations of Tissues in Hydrocelectomy Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04406077
• Other study ID #: 0117-17-HYMC
• Status: Completed
• Phase: N/A
• Start date: February 18, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: May 2020
• Source: Hillel Yaffe Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hydrocele is a condition of fluid retention around the testes, which causes swallowing, pain, with interfering with the normal testes function. however, during activity, this can interfere with everyday activity (running, sexual intercourse). The treatment for hydrocele I surgical. The study aim to test the safety and efficacy of the Ligasure (r) device for cutting and coagulating tissues during hydrocelectomy.

Description:

Hydrocele is a condition of fluid retention around the testes, which causes swallowing, pain, with interfering with the normal testes function. however, during activity, this can interfere with everyday activity (running, sexual intercourse). The treatment for hydrocele I surgical. The study aim to test the safety and efficacy of the Ligasure (r) device for cutting and coagulating tissues during hydrocelectomy. during the study, males, 18 - 81 who suffer from hydrocele underwent hydrocelectomy using Ligasure (20 cm) without using sutures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 81 Years

Eligibility

Inclusion Criteria:

• 18 - 81 males

• Diagnosed with unilateral hydrocele

Exclusion Criteria:

• Bilateral hydrocele

• infected hydrocele

• hydrocele secondary to tumor

Related Conditions & MeSH terms

• Hydrocele
• Testicular Hydrocele

Intervention

Device:
• Ligasure
Using ligasure to treat hydrocele

Locations

Country	Name	City	State
Israel	Hillel Yaffe MC,	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	resolution of hydrocele	The patients will undergo full urological physical exam to screen for signs of hydrocele. The testes size and manual palpation will be included in the assessment.	Three weeks after the surgery