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BleedingNCT06366984

Outcome of Plastibell Circumcision Versus Open Method Circumcision

A study testing plastibell and open method in people with Bleeding and Site Infection, run by Children Hospital and Institute of Child Health, Lahore at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To compare the outcomes of plastibell circumcision method with open surgical technique in infants presenting at tertiary care hospital. Methods This randomized controlled trial (NCT??) was conducted at Pediatric surgery department, the Children's hospital and the University of Child health, Lahore. Read more about this study

Who is it for?
Ages 1 day to 12 months, men onlyHealthy volunteers can take part
Conditions the study is for
Bleeding, Site Infection
What is being tested?
plastibell and open method
Could I receive a placebo?
No, everyone receives an active treatment
How many people
174 participants
Where
1 sitePakistan
Study dates
11 Jan 2022to 11 Aug 2022
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 1 day to 12 months
  • Men only
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • all uncircumcised male

Who cannot join

  • hypospadias, syndromic children

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • The Children Hospital

    Lahore, Punjab Province, 42000

Other trials in Pakistan

About this study

Official title: Comparison of Outcome of Plastibell Circumcision Method With Open Surgical Technique in Infants Presenting at Tertiary Care Hospital

To compare the outcomes of plastibell circumcision method with open surgical technique in infants presenting at tertiary care hospital.

Methods This randomized controlled trial (NCT??) was conducted at Pediatric surgery department, the Children's hospital and the University of Child health, Lahore. Study was carried out over a period of six months from 11-01-2022 to 11-07-2022. Non probability, purposive sampling was used. 174 infants presenting for circumcision were admitted and assigned a method of circumcision randomly. They were randomly divided in to 2 groups by using opaque sealed envelope technique. Infants in group A were underwent plastibell circumcision while infants in group B were underwent open technique circumcision. 87 circumcisions were performed by each method. The informed consent was taken from parents for inclusion into the study. All infants were underwent circumcision under local anesthesia as per assigned method. Same preoperative, per-operative, and postoperative care was given to each regardless of the technique. These patients were followed for 3 hours to assess bleeding as per operational definition. Then followed on an outpatient basis every 6th day until complete healing is achieved (30 days).The data regarding age, weight, duration of procedure, wound infection and post circumcision bleeding was recorded in a predesigned performa. (As per operational definition).

Read the detailed description

Circumcision is a surgical method in which surgical removal of the prepuce (foreskin) is done. Religious, cultural, medical, and common public health reasons are known to be the major indications for this procedure. It is usually done in neonatal age but can also be performed at any age. The WHO has begun to recommend circumcision on the basis of studies indicating its positive effects on human health and especially its role in protection from AIDS. As with adult circumcision, neonatal circumcision may be helpful to reduce the risk of acquiring HIV infection, phimosis and paraphimosis in future adult life. Though Circumcision is one of the commonest procedures in the surgery, still a gold standard approach is not defined. In Pakistan most circumcisions are done in neonatal or infant life, or circumcised in the adult age group. It is a relatively simple procedure with healing time up to 2 weeks.

There are many advantages of male circumcision at younger age than older, which include lower risk of complications, lower cost, and faster healing. Different techniques are being in practice like Plastibell method, Mogen Clamp, bone cutter technique and Free-hand open surgical method.

This randomized control trial was conducted at Pediatric Surgery Department, The Children's Hospital and University of Child Health Sciences, Lahore from 11-01-2022 to 11-07-2022. After approval from the ethical review committee of the hospital, all infants came for circumcision were included except those who need redo circumcision or have Inadequate clinical record or have hypospadias or who are syndromic children.

174 infants presenting for circumcision were admitted and assigned a method of circumcision randomly. They were randomly divided in to 2 groups by using opaque sealed envelope technique. Infants in group A were underwent plastibell circumcision while infants in group B were underwent open technique circumcision. 87 circumcisions were performed by each method. The informed consent was taken from parents for inclusion into the study. All infants were underwent circumcision under local anesthesia as per assigned method. Same preoperative, per-operative, and postoperative care was given to each regardless of the technique. These patients were followed for 3 hours to assess bleeding as per operational definition. Then followed on an outpatient basis every 6th day until complete healing is achieved (30 days).The data regarding age, weight, duration of procedure, wound infection and post circumcision bleeding was recorded in a predesigned performa. (As per operational definition).

The data was entered in SPSS version 23 and analyzed through it. Means and SD was calculated for quantitative variables like age, weight and operation time. Frequency and percentage was calculated for qualitative variables like bleeding and wound infection. Outcomes i.e bleeding and wound infection were compared between both groups by using Chi-square test. P-value ≤ 0.05 was considered significant.

Being tested
plastibell, open method
Keywords
Circumcision,, Infection, Bleeding,, Plastibell,
Medical subject headings
Hemorrhage, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • plastibellOther

    plastibell used for circumcision

  • open methodOther

    open method used for circumcision

Study groups in NCT06366984
Study groupRoleWhat they receive
Plastibell groupExperimentalplastibell method applied for circumcision
Receives: Other: plastibell
open method circumcisionExperimentalopen method of circumcision applied
Receives: Other: open method

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. infection

    incidence of surgical site infection according to southampton score

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2024
  2. Study start11 Jan 2022
  3. Primary completion11 Jul 2022
  4. Study completion11 Aug 2022

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controll trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
174 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06366984
Sponsor's protocol ID
Adeel4
Status last verified
Apr 2024
First submitted
8 Apr 2024
Last updated
16 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: no plan of sharing

Questions about this trial

What is this clinical trial studying?

A study testing plastibell and open method in people with Bleeding and Site Infection, run by Children Hospital and Institute of Child Health, Lahore at 1 site in Pakistan.

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 1 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 16 Apr 2024. 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 Pakistan. 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?

infection (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 16 Apr 2024.

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