NCT04653402

Determine the Efficacy of Closed Suction Drain After Hydrocelectomy. (END Trial)

Determine the Efficacy of Closed Suction Drain After Hydrocelectomy in Primary Vaginal Hydrocele: An Open-label Randomised Controlled Trial (END Trial)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: All India Institute of Medical Sciences, Bhubaneswar · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

There is no clear consensus regarding the benefits of putting a closed suction drain after eversion of the sac in a hydrocele of the tunica vaginalis testis. Our study will find out the benefits if at all of a closed suction drain in hydrocele surgery. The potential complications expected after hydrocelectomy surgery are bleeding, infection, redness, and pain. There is no such trial to date to determine the benefits of putting a closed suction drain after hydrocelectomy surgery.

Detailed description

Study objectives: 1. Primary: To compare the postoperative complication rates of hematoma, skin edema and surgical site infection after hydrocelectomy, between patients with or without a closed suction drain (CSD). 2. Secondary: To compare postoperative pain (testalgia) between the two groups of patients. Study setting: All patients over 18 years of age attending the outpatient department of General Surgery at AIIMS, Bhubaneswar with the diagnosis of idiopathic hydrocele and planned for elective surgery. Total Sample Size = 60 (30 in each arm)

Conditions

• Hydrocele of Tunica Vaginalis

Interventions

Type	Name	Description
DEVICE	Hydrocelectomy surgery	The standardized hydrocelectomy operation i.e. Eversion of the TVT sac

Timeline

• Start date: 2021-01-01
• Primary completion: 2023-06-30
• Completion: 2023-07-15
• First posted: 2020-12-04
• Last updated: 2023-07-25

Locations

1 site across 1 country: India