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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-07-15

Brief Summary

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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.

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Detailed Description

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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

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Hydrocele of Tunica Vaginalis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

open label randomised control trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study arm 1

Placing a closed suction drain after hydrocelectomy for primary vaginal hydrocele

Group Type EXPERIMENTAL

Hydrocelectomy surgery

Intervention Type DEVICE

The standardized hydrocelectomy operation i.e. Eversion of the TVT sac

Study arm 2

Not placing a drain after hydrocelectomy in primary vaginal hydrocele

Group Type ACTIVE_COMPARATOR

Hydrocelectomy surgery

Intervention Type DEVICE

The standardized hydrocelectomy operation i.e. Eversion of the TVT sac

Interventions

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Hydrocelectomy surgery

The standardized hydrocelectomy operation i.e. Eversion of the TVT sac

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No