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

All India Institute of Medical Sciences, Bhubaneswar

Status: Completed

Conditions: Hydrocele of Tunica Vaginalis

Treatments: Device: Hydrocelectomy surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04653402

T/IM-NF/Gen.Surg/20/45

Details and patient eligibility

About

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.

Full 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)

Enrollment: 100 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients over 18 years of age diagnosed with primary hydrocele by clinical and ultrasonographic confirmation, undergoing hydrocelectomy surgery.

Exclusion criteria

• Patient not giving consent to participate
• Patients with ASA (American Society of Anaesthesiology) grade 3 & 4
• Patients with congenital or secondary hydrocele
• Patients with recurrent disease, pyocele or filarial scrotum

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Study arm 1

Experimental group

Description:

Placing a closed suction drain after hydrocelectomy for primary vaginal hydrocele

Treatment:

Device: Hydrocelectomy surgery

Study arm 2

Active Comparator group

Description:

Not placing a drain after hydrocelectomy in primary vaginal hydrocele

Treatment:

Device: Hydrocelectomy surgery