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

Study Overview
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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.

Detailed Description
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Study objectives: 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). 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)

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

Conditions
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Hydrocele of Tunica Vaginalis

Intervention / Treatment
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* Device: Hydrocelectomy surgery


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: open label randomised control trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study arm 1<br>Placing a closed suction drain after hydrocelectomy for primary vaginal hydrocele | Device: Hydrocelectomy surgery<br>* The standardized hydrocelectomy operation i.e. Eversion of the TVT sac<br>|
| Active Comparator: Study arm 2<br>Not placing a drain after hydrocelectomy in primary vaginal hydrocele | Device: Hydrocelectomy surgery<br>* The standardized hydrocelectomy operation i.e. Eversion of the TVT sac<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin edema | Boggy swelling of scrotal wall | Post operative period of 1 month | 
| Hematoma | Post-operative swelling of scrotum with skin discolouration and oozing of blood through the incision site | 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 | Post operative period of 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | post operative period of 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hydrocele, Drain, Surgery, Complications, Hydrocelectomy, Hematoma, Infection