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.
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.
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.
- Conditions
- Bleeding, Site Infection
- 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 group | Role | What they receive |
|---|---|---|
| Plastibell group | Experimental | plastibell method applied for circumcision Receives: Other: plastibell |
| open method circumcision | Experimental | open 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.
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.
- First posted16 Apr 2024
- Study start11 Jan 2022
- Primary completion11 Jul 2022
- Study completion11 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BleedingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controll trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children Hospital and Institute of Child Health, Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Adeel Ashiq, Children Hospital and Institute of Child Health, Lahore
- Investigators
- Muhammad A Ashiq, M.S, Principal investigator, The Children hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcome of Plastibell Circumcision Method With Open Surgical Technique in Infants Presenting at Tertiary Care Hospital
- ClinicalTrials.gov ID
- NCT06366984
- Acronym / sponsor ID
- Adeel4
- Conditions
- Bleeding, Site Infection
- Keywords
- Circumcision,, Infection, Bleeding,, Plastibell,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Children Hospital and Institute of Child Health, LahoreUniversity, hospital or other
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 11 Jul 2022 (actual)
- Study completion
- 11 Aug 2022 (actual)
- First posted
- 16 Apr 2024 (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.
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).
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controll trial
| Arm | Type | Receives |
|---|---|---|
| Plastibell group | Experimental | Other: plastibellplastibell method applied for circumcision |
| open method circumcision | Experimental | Other: open methodopen method of circumcision applied |
Who may qualify
- Ages
- 1 day to 12 months
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- all uncircumcised male
Key exclusion criteria (1 listed)
- hypospadias, syndromic children
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 |
|---|---|---|
| plastibellplastibell used for circumcision | Other | Plastibell group |
| open methodopen method used for circumcision | Other | open method circumcision |
Primary outcome
infection
Time frame: 30 days
incidence of surgical site infection according to southampton score
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 16 Apr 2024.
- Individual participant dataSharing planned: No. no plan of sharing
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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.
Muhammad A Ashiq, M.S principal investigator
The Children hospital
1 site in 1 country: see every site and its status.
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.