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

All India Institute of Medical Sciences, Bhubaneswar100 enrolled

Overview

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.

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Hydrocele of Tunica Vaginalis

Interventions

Hydrocelectomy surgeryDEVICE

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

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

All India institute of medical sciences

Bhubaneswar, Odisha, India

Outcomes

Primary Outcomes

Skin edema

Boggy swelling of scrotal wall

Time frame: Post operative period of 1 month

Hematoma

Post-operative swelling of scrotum with skin discolouration and oozing of blood through the incision site

Time frame: Post operative period of 1 month

Surgical site infection

Seropurulent discharge from the incision site with systemic signs of infection like fever, tachycardia and local signs like edema, redness and tenderness

Time frame: Post operative period of 1 month

Secondary Outcomes

Testalgia

Visual Analog Scale scoring on a 100 mm length scale ( low score with no pain to higher scores with worst imaginable pain) for acute and sub acute testalgia

Time frame: post operative period of 1 month

Data from ClinicalTrials.gov

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