---
title: Determine the Efficacy of Closed Suction Drain After Hydrocelectomy. (END Trial)
nct_id: NCT04653402
overall_status: COMPLETED
phase: NA
sponsor: All India Institute of Medical Sciences, Bhubaneswar
study_type: INTERVENTIONAL
primary_condition: Hydrocele of Tunica Vaginalis
countries: India
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04653402.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04653402"
ct_last_update_post_date: 2023-07-25
last_seen_at: "2026-05-12T07:10:46.813Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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)

**NCT ID:** [NCT04653402](https://clinicaltrials.gov/study/NCT04653402)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 100
- **Lead Sponsor:** All India Institute of Medical Sciences, Bhubaneswar
- **Conditions:** Hydrocele of Tunica Vaginalis
- **Start Date:** 2021-01-01
- **Completion Date:** 2023-07-15
- **CT.gov Last Update:** 2023-07-25

## 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

- **Minimum age:** 18 Years
- **Sex:** MALE
- **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
```

## Arms

- **Study arm 1** (EXPERIMENTAL) — Placing a closed suction drain after hydrocelectomy for primary vaginal hydrocele
- **Study arm 2** (ACTIVE_COMPARATOR) — Not placing a drain after hydrocelectomy in primary vaginal hydrocele

## Interventions

- **Hydrocelectomy surgery** (DEVICE) — The standardized hydrocelectomy operation i.e. Eversion of the TVT sac

## Primary Outcomes

- **Skin edema** _(time frame: Post operative period of 1 month)_ — Boggy swelling of scrotal wall
- **Hematoma** _(time frame: 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** _(time frame: 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 Outcomes

- **Testalgia** _(time frame: post operative period of 1 month)_

## Locations (1)

- All India institute of medical sciences, Bhubaneswar, Odisha, India

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.all india institute of medical sciences|bhubaneswar|odisha|india` — added _(2026-05-12)_

---

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