Hydrocele of Tunica Vaginalis
Conditions
Keywords
Hydrocele, Drain, Surgery, Complications, Hydrocelectomy, Hematoma, Infection
Brief summary
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
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)
Interventions
DEVICEHydrocelectomy surgery
The standardized hydrocelectomy operation i.e. Eversion of the TVT sac
Sponsors
All India Institute of Medical Sciences, Bhubaneswar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
open label randomised control trial
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin edema | Post operative period of 1 month | Boggy swelling of scrotal wall |
| Hematoma | Post operative period of 1 month | Post-operative swelling of scrotum with skin discolouration and oozing of blood through the incision site |
| Surgical site infection | 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
| Measure | Time frame | Description |
|---|---|---|
| Testalgia | 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 |
Countries
India
Outcome results
None listed