Hydrocele of Tunica Vaginalis Clinical Trial
— ENDOfficial title:
Determine the Efficacy of Closed Suction Drain After Hydrocelectomy in Primary Vaginal Hydrocele: An Open-label Randomised Controlled Trial (END Trial)
| Verified date | July 2023 |
| Source | All India Institute of Medical Sciences, Bhubaneswar |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | July 15, 2023 |
| Est. primary completion date | June 30, 2023 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| India | All India institute of medical sciences | Bhubaneswar | Odisha |
| Lead Sponsor | Collaborator |
|---|---|
| All India Institute of Medical Sciences, Bhubaneswar |
India,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Skin edema | Boggy swelling of scrotal wall | Post operative period of 1 month | |
| Primary | Hematoma | Post-operative swelling of scrotum with skin discolouration and oozing of blood through the incision site | Post operative period of 1 month | |
| Primary | 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 | 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 |