Circumcision, MaleNCT06120634
Comparison of Outcomes of Circumcision Via Open and Plastibell Methods
A study testing Open surgical method and Plastibell method in people with Circumcision, Male, run by Tehsil Headquarter Hospital at 1 site in Pakistan.
Trial summary
Circumcision is considered one of the most common elective surgical procedures, particularly among Muslim and Jewish males. Of all the available techniques, Plastibell is gaining traction amongst surgeons due to its safety in the form of a lower complication rate. Read more about this study
- Who is it for?
- Ages 1 month to 60 months, men onlyHealthy volunteers can take part
- Conditions the study is for
- Circumcision, Male
- What is being tested?
- Open surgical method and Plastibell method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 608 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Jul 2018to 31 Oct 2020
- 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 month to 60 months
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy males up to 5 years of age
- Signed, informed consent of parents/guardians
Who cannot join
- Boys with bleeding disorders, severe jaundice, or genital abnormalities like hypospadias, epispadias, congenital chordee.
- Whose parents did not give consent
- Boys with a larger glans size not feasible for Plastibell circumcision
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Tehsil Headquarters Hospital Ferozewala
Sheikhupura, Punjab Province
About this study
Official title: A Quasi-experimental Study Comparing Outcomes and Parent's Responses in 600+ Circumcised Boys in a Lower-Middle Income Country
Circumcision is considered one of the most common elective surgical procedures, particularly among Muslim and Jewish males. Of all the available techniques, Plastibell is gaining traction amongst surgeons due to its safety in the form of a lower complication rate. The current quasi-experimental study aimed to compare the Open and Plastibell methods of circumcision in a study population which comprised of boys up to 5 years of age who were grouped into the Open method and Plastibell based on parental preference. Follow-up occurred on the 5th, 10th, and, 30th post-procedural day. Basic demographic data, procedural duration, and outcomes were documented.
Read the detailed description
This study was conducted to compare the Open and Plastibell method of circumcision in boys up to 5-years of age, in terms of procedural time, outcomes and parental satisfaction.
This was a quasi-experimental study of boys up to 5-years of age. Boys meeting the inclusion criteria were categorized into two groups based on parental preference - Open method and Plastibell. Patients were followed-up on the 5th, 10th and 30th post-procedural day. Basic demographic data, procedural duration, and outcomes were documented.
Of 646 boys brought to the hospital for circumcision, 608 met the inclusion criteria with equal participants in both groups. The median age in Open and Plastibell groups was three and five months respectively. The median operating time was significantly shorter in the Plastibell group (4.2 min) compared to the Open method (13 min). Of the complications recorded in 91 children, more were observed in Plastibell group. Post-procedure bleeding occurred in 1.2% children (n=7). Open method resulted in infection, excessive skin removal (n=8 each) and urinary retention (n=7) whereas Plastibell impaction (n=21) and inadequate skin removal (n=19) were the commonest complications in the Plastibell group which were significantly associated with age of the boys. There were no serious adverse events. Open method was preferred by parents for cosmesis and Plastibell for ease of care.
It is concluded that Plastibell, compared to open method, is a quicker method of circumcision and is safe for boys up to 5-years of age, however, earlier circumcisions are associated with lesser complications. The follow-up ensures patient safety.
- Conditions
- Circumcision, Male
- Being tested
- Open surgical method, Plastibell method
- Keywords
- Circumcision, Open method, Plastibell method, Complications, Outcomes, Parental response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open surgical methodProcedure or surgery
After separating the preputial skin from glans and removing smegma, two artery clips were applied on the dorsal skin in the center to mark the skin to be divided. Crushing the skin for a couple of minutes, prior to incising, helps to reduce bleeding. The skin was cut about 2-3 mm short of the coronal sulcus. Similarly, 2-3 mm cuff of prepuce was circumferentially cut proximal to the corona. Using bipolar diathermy or catgut 4/0, frenular artery along with dorsal artery and vein of penis were coagulated or ligated respectively to achieve hemostasis. The skin and prepuce were approximated and sutured with catgut 4/0 at four places- ventral, dorsal, and two lateral points. Finally, a dressing with antibiotic ointment was applied to the wound.
Plastibell methodProcedure or surgery
The prepuce was separated all around the glans, up to the coronal sulcus, and smegma was removed. A dorsal slit in the skin was made, after crushing the skin for a couple of minutes, long enough to accommodate the passage of an appropriate-sized plastibell. Once the distal edge of the bell snugly fit at or near the coronal sulcus, a ligature was applied and tightened around the sulcus on the bell. The extra preputial skin was cut with either scissors or a surgical blade, after breaking apart and discarding the handle of the plastibell. The urethral meatus was examined and its visibility was ensured prior to returning the baby boy to his parents. The baby was kept under observation for 30 minutes in the surgical ward and re-examined to ensure there was no hematoma or bleeding.
| Study group | Role | What they receive |
|---|---|---|
| Open surgical method | Active comparator | In this group, the participants were circumcised using the open method. A total of 304 patients were enrolled in this group. Receives: Procedure: Open surgical method |
| Plastibell method | Active comparator | A total of 304 patients were enrolled in this group and underwent the process of circumcision by the Plastibell method. Receives: Procedure: Plastibell method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative bleeding
Bleeding from the site of circumcision
Measured: From post-operative day 0 to day+30
Post-operative urinary retention
Urinary retention by the patient as reported by the parents/guardians/caregivers
Measured: From post-operative day 0 to day+30
Infection
Swelling, pain, redness, warm to touch as felt by the parents/guardians/caregivers
Measured: From post-operative day 0 to day+30
Over circumcision
Total number of participants with extra skin removed during the circumcision than required
Measured: From post-operative day 0 to day+30
Under circumcision
Number of participants with less skin removed during the circumcision covering half of glans penis
Measured: From post-operative day 0 to day+30
Bell impaction
Number of participants with the head of the penis gets stuck to the Plastibell
Measured: From post-operative day 0 to day+30
Delayed shedding of the ring
Number of participants with failure of Plastibell to shed on its own
Measured: From post-operative day 0 to day+10
Post-procedural phimosis/paraphimosis
Number of participants with entrapment of a retracted foreskin behind the coronal sulcus
Measured: From post-operative day 0 to day+30
Secondary outcomes (2)
Ease of care
total number of Parents' ease in the change of diapers, clothes, and giving bath to the baby assessed subjectively through interview of parents
Measured: From post-operative day 0 to day+30
Satisfaction with cosmetic appearance
Total number of parents satisfied with the appearance of penis after the circumcision
Measured: From post-operative day 0 to day+30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start2 Jul 2018
- Primary completion30 Sep 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circumcision, MaleStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 608 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehsil Headquarter Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ali Kamran, Tehsil Headquarter Hospital
- Investigators
- Ali Kamran, FCPS, Principal investigator, Tehsil Headquarters Hospital Ferozewala, Sheikhupura, Punjab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120634
- Sponsor's protocol ID
- 794/MS/THQ/FW
- Status last verified
- Nov 2023
- First submitted
- 25 Sep 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Quasi-experimental Study Comparing Outcomes and Parent's Responses in 600+ Circumcised Boys in a Lower-Middle Income Country
- ClinicalTrials.gov ID
- NCT06120634
- Acronym / sponsor ID
- 794/MS/THQ/FW
- Conditions
- Circumcision, Male
- Keywords
- Circumcision, Open method, Plastibell method, Complications, Outcomes, Parental response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 608 participants (actual)
- Lead sponsor
- Tehsil Headquarter HospitalOther government
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 7 Nov 2023 (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.
Circumcision is considered one of the most common elective surgical procedures, particularly among Muslim and Jewish males. Of all the available techniques, Plastibell is gaining traction amongst surgeons due to its safety in the form of a lower complication rate. The current quasi-experimental study aimed to compare the Open and Plastibell methods of circumcision in a study population which comprised of boys up to 5 years of age who were grouped into the Open method and Plastibell based on parental preference. Follow-up occurred on the 5th, 10th, and, 30th post-procedural day. Basic demographic data, procedural duration, and outcomes were documented.
Detailed description
This study was conducted to compare the Open and Plastibell method of circumcision in boys up to 5-years of age, in terms of procedural time, outcomes and parental satisfaction.
This was a quasi-experimental study of boys up to 5-years of age. Boys meeting the inclusion criteria were categorized into two groups based on parental preference - Open method and Plastibell. Patients were followed-up on the 5th, 10th and 30th post-procedural day. Basic demographic data, procedural duration, and outcomes were documented.
Of 646 boys brought to the hospital for circumcision, 608 met the inclusion criteria with equal participants in both groups. The median age in Open and Plastibell groups was three and five months respectively. The median operating time was significantly shorter in the Plastibell group (4.2 min) compared to the Open method (13 min). Of the complications recorded in 91 children, more were observed in Plastibell group. Post-procedure bleeding occurred in 1.2% children (n=7). Open method resulted in infection, excessive skin removal (n=8 each) and urinary retention (n=7) whereas Plastibell impaction (n=21) and inadequate skin removal (n=19) were the commonest complications in the Plastibell group which were significantly associated with age of the boys. There were no serious adverse events. Open method was preferred by parents for cosmesis and Plastibell for ease of care.
It is concluded that Plastibell, compared to open method, is a quicker method of circumcision and is safe for boys up to 5-years of age, however, earlier circumcisions are associated with lesser complications. The follow-up ensures patient safety.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open surgical method | Active comparator | Procedure: Open surgical methodIn this group, the participants were circumcised using the open method. A total of 304 patients were enrolled in this group. |
| Plastibell method | Active comparator | Procedure: Plastibell methodA total of 304 patients were enrolled in this group and underwent the process of circumcision by the Plastibell method. |
Who may qualify
- Ages
- 1 month to 60 months
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Healthy males up to 5 years of age
- Signed, informed consent of parents/guardians
Key exclusion criteria (3 listed)
- Boys with bleeding disorders, severe jaundice, or genital abnormalities like hypospadias, epispadias, congenital chordee.
- Whose parents did not give consent
- Boys with a larger glans size not feasible for Plastibell circumcision
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 |
|---|---|---|
| Open surgical methodAfter separating the preputial skin from glans and removing smegma, two artery clips were applied on the dorsal skin in the center to mark the skin to be divided. Crushing the skin for a couple of minutes, prior to incising, helps to reduce bleeding. The skin was cut about 2-3 mm short of the coronal sulcus. Similarly, 2-3 mm cuff of prepuce was circumferentially cut proximal to the corona. Using bipolar diathermy or catgut 4/0, frenular artery along with dorsal artery and vein of penis were coagulated or ligated respectively to achieve hemostasis. The skin and prepuce were approximated and sutured with catgut 4/0 at four places- ventral, dorsal, and two lateral points. Finally, a dressing with antibiotic ointment was applied to the wound. | Procedure or surgery | Open surgical method |
| Plastibell methodThe prepuce was separated all around the glans, up to the coronal sulcus, and smegma was removed. A dorsal slit in the skin was made, after crushing the skin for a couple of minutes, long enough to accommodate the passage of an appropriate-sized plastibell. Once the distal edge of the bell snugly fit at or near the coronal sulcus, a ligature was applied and tightened around the sulcus on the bell. The extra preputial skin was cut with either scissors or a surgical blade, after breaking apart and discarding the handle of the plastibell. The urethral meatus was examined and its visibility was ensured prior to returning the baby boy to his parents. The baby was kept under observation for 30 minutes in the surgical ward and re-examined to ensure there was no hematoma or bleeding. | Procedure or surgery | Plastibell method |
Primary outcome
Post-operative bleeding
Time frame: From post-operative day 0 to day+30
Bleeding from the site of circumcision
Post-operative urinary retention
Time frame: From post-operative day 0 to day+30
Urinary retention by the patient as reported by the parents/guardians/caregivers
Infection
Time frame: From post-operative day 0 to day+30
Swelling, pain, redness, warm to touch as felt by the parents/guardians/caregivers
Over circumcision
Time frame: From post-operative day 0 to day+30
Total number of participants with extra skin removed during the circumcision than required
Under circumcision
Time frame: From post-operative day 0 to day+30
Number of participants with less skin removed during the circumcision covering half of glans penis
Bell impaction
Time frame: From post-operative day 0 to day+30
Number of participants with the head of the penis gets stuck to the Plastibell
Delayed shedding of the ring
Time frame: From post-operative day 0 to day+10
Number of participants with failure of Plastibell to shed on its own
Post-procedural phimosis/paraphimosis
Time frame: From post-operative day 0 to day+30
Number of participants with entrapment of a retracted foreskin behind the coronal sulcus
2 secondary outcomes
Ease of care
Time frame: From post-operative day 0 to day+30
Satisfaction with cosmetic appearance
Time frame: From post-operative day 0 to day+30
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 7 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Ali Kamran, FCPS principal investigator
Tehsil Headquarters Hospital Ferozewala, Sheikhupura, Punjab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open surgical method and Plastibell method in people with Circumcision, Male, run by Tehsil Headquarter Hospital 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 2 inclusion and 3 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 7 Nov 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 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?
Post-operative bleeding (time frame: From post-operative day 0 to day+30). The study lists 8 primary outcomes in all. 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 7 Nov 2023.