Clinical trial NCT04653402: Determine the Efficacy of Closed Suction Drain After Hydrocelectomy. (END Trial)
Official title: Determine the Efficacy of Closed Suction Drain After Hydrocelectomy in Primary Vaginal Hydrocele: An Open-label Randomised Controlled Trial (END Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hydrocele of Tunica Vaginalis
Keywords: Hydrocele
Drain
Surgery
Complications
Hydrocelectomy
Hematoma
Infection
Lead sponsor: All India Institute of Medical Sciences, Bhubaneswar
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: open label randomised control trial
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: Skin edema
timeFrame: Post operative period of 1 month
measure: Hematoma
timeFrame: Post operative period of 1 month
measure: Surgical site infection
timeFrame: Post operative period of 1 month
Secondary outcomes:
measure: Testalgia
timeFrame: post operative period of 1 month
Other outcomes:
Locations:
city: Bhubaneswar
country: India
facility: All India institute of medical sciences
state: Odisha
Study officials:
affiliation: All India Institute of Medical Sciences, Bhubaneswar, INDIA
name: Prakash K. Sasmal, MS,FNB,FAIS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dagur G, Gandhi J, Suh Y, Weissbart S, Sheynkin YR, Smith NL, Joshi G, Khan SA. Classifying Hydroceles of the Pelvis and Groin: An Overview of Etiology, Secondary Complications, Evaluation, and Management. Curr Urol. 2017 Apr;10(1):1-14. doi: 10.1159/000447145. Epub 2017 Mar 30.
citation: Tsai L, Milburn PA, Cecil CL 4th, Lowry PS, Hermans MR. Comparison of Recurrence and Postoperative Complications Between 3 Different Techniques for Surgical Repair of Idiopathic Hydrocele. Urology. 2019 Mar;125:239-242. doi: 10.1016/j.urology.2018.12.004. Epub 2018 Dec 12.
citation: Agbakwuru EA, Salako AA, Olajide AO, Takure AO, Eziyi AK. Hydrocelectomy under local anaesthesia in a Nigerian adult population. Afr Health Sci. 2008 Sep;8(3):160-2.
citation: Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
citation: Patil V, Shetty SM, Das S. Common and Uncommon Presentation of Fluid within the Scrotal Spaces. Ultrasound Int Open. 2015 Nov;1(2):E34-40. doi: 10.1055/s-0035-1555919. Epub 2015 Nov 6.