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

Not Applicable

Completed

• Conditions: Hydrocele of Tunica Vaginalis
• Interventions: Device: Hydrocelectomy surgery

• Registration Number: NCT04653402
• Lead Sponsor: All India Institute of Medical Sciences, Bhubaneswar

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)

Study Timeline

• Study First Submitted: 2020-10-10
• Study First Submitted QC: 2020-11-28
• Study First Posted: 2020-12-04
• Study Start: 2021-01-01
• Primary Completion: 2023-06-30
• Status Verified: 2023-07
• Study Completion: 2023-07-15
• Last Update Submitted: 2023-07-21
• Last Update Posted: 2023-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study arm 1	Hydrocelectomy surgery	Placing a closed suction drain after hydrocelectomy for primary vaginal hydrocele
Study arm 2	Hydrocelectomy surgery	Not placing a drain after hydrocelectomy in primary vaginal hydrocele

Primary Outcome Measures

Name	Time	Method
Hematoma	Post operative period of 1 month	Post-operative swelling of scrotum with skin discolouration and oozing of blood through the incision site
Skin edema	Post operative period of 1 month	Boggy swelling of scrotal wall
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

All India institute of medical sciences; 🇮🇳 Bhubaneswar, Odisha, India