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

July 21, 2023 updated by: Dr. Prakash Kumar Sasmal, All India Institute of Medical Sciences, Bhubaneswar

Determine the Efficacy of Closed Suction Drain After Hydrocelectomy in Primary Vaginal Hydrocele: An Open-label Randomised Controlled Trial (END Trial)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Odisha
      • Bhubaneswar, Odisha, India, 751019
        • All India Institute of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study arm 1
Placing a closed suction drain after hydrocelectomy for primary vaginal hydrocele
Device: Hydrocelectomy surgery
The standardized hydrocelectomy operation i.e. Eversion of the TVT sac
Active Comparator: Study arm 2
Not placing a drain after hydrocelectomy in primary vaginal hydrocele
Device: Hydrocelectomy surgery
The standardized hydrocelectomy operation i.e. Eversion of the TVT sac

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin edema
Time Frame: Post operative period of 1 month
Boggy swelling of scrotal wall
Post operative period of 1 month
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
Post operative period of 1 month
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
Post operative period of 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Testalgia
Time Frame: 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
post operative period of 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, Bhubaneswar

Investigators

  • Principal Investigator: Prakash K. Sasmal, MS,FNB,FAIS, All India Institute of Medical Sciences, Bhubaneswar, India

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

July 15, 2023

Study Registration Dates

First Submitted

October 10, 2020

First Submitted That Met QC Criteria

November 28, 2020

First Posted (Actual)

December 4, 2020

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 21, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T/IM-NF/Gen.Surg/20/45

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Participant information sheet and participant consent form and study protocol.

IPD Sharing Time Frame

Before the start of the study

IPD Sharing Access Criteria

IEC

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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