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NCT Number: NCT04653402

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

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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Key information

Conditions

Hydrocele of Tunica Vaginalis Endocrine System Diseases Genital Diseases Genital Diseases, Male Gonadal Disorders Hematoma Hemorrhage Infections Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Testicular Diseases Testicular Hydrocele Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

All India institute of medical sciences

Bhubaneswar, Odisha, 751019, India

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrocelectomy surgery

Device

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

Primary outcomes

  1. Skin edema

    Time frame: Post operative period of 1 month

    Boggy swelling of scrotal wall

  2. Hematoma

    Time frame: Post operative period of 1 month

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

  3. Surgical site infection

    Time frame: Post operative period of 1 month

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

Secondary outcomes

  1. Testalgia

    Time frame: post operative period of 1 month

    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

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences, Bhubaneswar

Other

Registry information

Official study title

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

Acronym: END

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 4, 2020
Registry last updated
Jul 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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