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

NCT04653402 | Completed DMC

• 1 other identifier: T/IM-NF/Gen.Surg/20/45
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hydrocele of Tunica Vaginalis

Keywords

Hydrocele; Drain; Surgery; Complications; Hydrocelectomy; Hematoma; Infection

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Testalgia

  post operative period of 1 month

Study Arms (2)

Study arm 1

EXPERIMENTAL

Placing a closed suction drain after hydrocelectomy for primary vaginal hydrocele

Device: Hydrocelectomy surgery

Study arm 2

ACTIVE COMPARATOR

Not placing a drain after hydrocelectomy in primary vaginal hydrocele

Device: Hydrocelectomy surgery

Interventions

Hydrocelectomy surgery DEVICE

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

Study arm 1; Study arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- All patients over 18 years of age diagnosed with primary hydrocele by clinical and ultrasonographic confirmation, undergoing hydrocelectomy surgery.

You may not qualify if:

• 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

Sponsors & Collaborators

• All India Institute of Medical Sciences, Bhubaneswar: lead

Study Sites (1)

All India institute of medical sciences

Bhubaneswar, Odisha, 751019, India

Location

Related Publications (5)

• 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.

  PMID: 28559772 BACKGROUND

• 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.

  PMID: 30552941 BACKGROUND

• 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.

  PMID: 19357743 BACKGROUND

• 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.

  PMID: 26092476 BACKGROUND

• 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.

  PMID: 27689151 RESULT

Related Links

• 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.
• Hydrocelectomy under local anaesthesia in a Nigerian adult population.
• omparison of Recurrence and Postoperative Complications Between 3 Different Techniques for Surgical Repair of Idiopathic Hydrocele.
• Common and Uncommon Presentation of Fluid within the Scrotal Spaces. Ultrasound Int Open

MeSH Terms

Conditions

Testicular Hydrocele; Hematoma; Infections

Condition Hierarchy (Ancestors)

Testicular Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Gonadal Disorders; Endocrine System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Prakash K. Sasmal, MS,FNB,FAIS

  All India Institute of Medical Sciences, Bhubaneswar, INDIA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor,Dept of General Surgery

Model Details: open label randomised control trial

Study Record Dates

• First Submitted: October 10, 2020
• First Posted: December 4, 2020
• Study Start: January 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: July 15, 2023
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Before the start of the study
• Access Criteria: IEC

Locations

IN (1)