Hydrocele of Tunica VaginalisENDNCT04653402
Determine the Efficacy of Closed Suction Drain After Hydrocelectomy. (END Trial)
A study testing Hydrocelectomy surgery in people with Hydrocele of Tunica Vaginalis, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hydrocele of Tunica Vaginalis
- What is being tested?
- Hydrocelectomy surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2021to 15 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients over 18 years of age diagnosed with primary hydrocele by clinical and ultrasonographic confirmation, undergoing hydrocelectomy surgery.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
Study objectives:
- 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).
- 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)
- Conditions
- Hydrocele of Tunica Vaginalis
- Being tested
- Hydrocelectomy surgery
- Keywords
- Hydrocele, Drain, Surgery, Complications, Hydrocelectomy, Hematoma, Infection
- Medical subject headings
- Testicular Hydrocele, Hematoma, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrocelectomy surgeryDevice
The standardized hydrocelectomy operation i.e. Eversion of the TVT sac
| Study group | Role | What they receive |
|---|---|---|
| Study arm 1 | Experimental | Placing a closed suction drain after hydrocelectomy for primary vaginal hydrocele Receives: Device: Hydrocelectomy surgery |
| Study arm 2 | Active comparator | Not placing a drain after hydrocelectomy in primary vaginal hydrocele Receives: Device: Hydrocelectomy surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin edema
Boggy swelling of scrotal wall
Measured: Post operative period of 1 month
Hematoma
Post-operative swelling of scrotum with skin discolouration and oozing of blood through the incision site
Measured: 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
Measured: Post operative period of 1 month
Secondary outcomes (1)
Testalgia
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
Measured: post operative period of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start1 Jan 2021
- Primary completion30 Jun 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hydrocele of Tunica VaginalisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- open label randomised control trial
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Prakash Kumar Sasmal, All India Institute of Medical Sciences, Bhubaneswar
- Investigators
- Prakash K. Sasmal, MS,FNB,FAIS, Principal investigator, All India Institute of Medical Sciences, Bhubaneswar, INDIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653402
- Sponsor's protocol ID
- T/IM-NF/Gen.Surg/20/45
- Acronym
- END
- Status last verified
- Jul 2023
- First submitted
- 10 Oct 2020
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant information sheet and participant consent form and study protocol.
Publications
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.
PubMed 28559772Tsai 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.
PubMed 30552941Agbakwuru 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.
PubMed 19357743Whitehead 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.
PubMed 26092476Patil 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.
PubMed 27689151
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determine the Efficacy of Closed Suction Drain After Hydrocelectomy in Primary Vaginal Hydrocele: An Open-label Randomised Controlled Trial (END Trial)
- ClinicalTrials.gov ID
- NCT04653402
- Acronym / sponsor ID
- END / T/IM-NF/Gen.Surg/20/45
- Conditions
- Hydrocele of Tunica Vaginalis
- Keywords
- Hydrocele, Drain, Surgery, Complications, Hydrocelectomy, Hematoma, Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- All India Institute of Medical Sciences, BhubaneswarUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open label randomised control trial
| Arm | Type | Receives |
|---|---|---|
| Study arm 1 | Experimental | Device: Hydrocelectomy surgeryPlacing a closed suction drain after hydrocelectomy for primary vaginal hydrocele |
| Study arm 2 | Active comparator | Device: Hydrocelectomy surgeryNot placing a drain after hydrocelectomy in primary vaginal hydrocele |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients over 18 years of age diagnosed with primary hydrocele by clinical and ultrasonographic confirmation, undergoing hydrocelectomy surgery.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrocelectomy surgeryThe standardized hydrocelectomy operation i.e. Eversion of the TVT sac | Device | Study arm 1, Study arm 2 |
Primary outcome
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
1 secondary outcome
Testalgia
Time frame: post operative period of 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Background: PubMed 28559772Dagur 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.
- Background: PubMed 30552941Tsai 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.
- Background: PubMed 19357743Agbakwuru 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.
- Background: PubMed 26092476Whitehead 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.
- Results publication: PubMed 27689151Patil 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.
- 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.Link provided by the sponsor.
- Hydrocelectomy under local anaesthesia in a Nigerian adult population.Link provided by the sponsor.
- omparison of Recurrence and Postoperative Complications Between 3 Different Techniques for Surgical Repair of Idiopathic Hydrocele.Link provided by the sponsor.
- Common and Uncommon Presentation of Fluid within the Scrotal Spaces. Ultrasound Int OpenLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Participant information sheet and participant consent form and study protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prakash K. Sasmal, MS,FNB,FAIS principal investigator
All India Institute of Medical Sciences, Bhubaneswar, INDIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrocelectomy surgery in people with Hydrocele of Tunica Vaginalis, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin edema (time frame: Post operative period of 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04653402, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.