CircumcisionNCT05590052
Bipolar Electrosurgery Versus Thermocautery in Circumcision With Safe Anesthetic Techniques
A study testing Bipolar Electrosurgery and Thermocautery in people with Circumcision, run by Damanhour Teaching Hospital at 1 site in Egypt.
Trial summary
Background: Circumcision is the most commonly performed surgical procedure done among the pediatric age group worldwide and is considered to be one of the oldest operations done. Circumcision should be performed properly with safe surgical techniques, with the least possibility of complications. Read more about this study
- Who is it for?
- Ages 1 month to 12 months, men only
- Conditions the study is for
- Circumcision
- What is being tested?
- Bipolar Electrosurgery and Thermocautery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 15 Jan 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 1 month to 12 months
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Infants of families who applied for circumcision
- Age from 1 to 12 months, of the male sex
- Infants should have normal preoperative laboratory investigations
Who cannot join
- Infants with congenital malformations especially hypospadias and epispadias, congenital inguinal hernia, and undescended testis
- Infants with acute penile infection, or excess suprapubic fat
- Infants with cardiovascular, neurological, respiratory, liver, renal, endocrine, blood, or immune diseases
- Allergy to any drug will be used in this study
Trial locations and contacts
1 site in 1 country.
About this study
Background: Circumcision is the most commonly performed surgical procedure done among the pediatric age group worldwide and is considered to be one of the oldest operations done. Circumcision should be performed properly with safe surgical techniques, with the least possibility of complications.
Objective: To compare bipolar electrosurgery versus thermocautery in the circumcision of infants under combined general and local anesthesia.
Patients and Methods: This prospective randomized comparative study was carried out on 110 infants who were candidates for elective circumcision under combined general and local anesthesia. Infants were randomly allocated into two equal groups (55 infants each); in group A, circumcised by bone-cutting forceps with cutting foreskin using a scalpel and achievement of hemostasis using bipolar electrosurgery, and in group B, circumcised by bone-cutting forceps with cutting foreskin and achievement of hemostasis using thermocautery.
- Conditions
- Circumcision
- Being tested
- Bipolar Electrosurgery, Thermocautery
- Keywords
- Circumcision, Electrosurgery, Thermocautery
- Medical subject headings
- Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bipolar ElectrosurgeryDevice
Achievement of hemostasis using bipolar electrosurgery
ThermocauteryDevice
achievement of hemostasis using thermocautery
| Study group | Role | What they receive |
|---|---|---|
| Bipolar Electrosurgery group (n=60) | Active comparator | Group A Receives: Device: Bipolar Electrosurgery |
| Thermocautery group (n=60) | Active comparator | Group B Receives: Device: Thermocautery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean and Standard deviation of postoperative analgesic doses (mean±SD)
Number of analgesic doses given after the end of the operation
Measured: 72 hours after the end of the operation
Secondary outcomes (3)
Mean and Standard deviation of Operative duration (minutes) (mean±SD)
Time from holding the penis till dresssing of the penis
Measured: 2 minutes after the end of the operation
Number of participants and Rate of Intraoperative complications
Number of participants and Rate of: Tachycardia, Bradycardia, Laryngeal spasm, Hypoxia, Bleeding, Glans injury, and Vomiting.
Measured: 2 minutes after the end of the operation
Number of participants and Rate of Postoperative complications
Number of participants and Rate of: Bleeding requiring surgical intervention, Penile edema, Wound infection, Meatal stenosis, and Trapped penis.
Measured: 4 weeks after the end of the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start1 Sep 2022
- Primary completion15 Jan 2023
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CircumcisionStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour Teaching Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ahmed M Shaat, MD, Principal investigator, Damanhour Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590052
- Sponsor's protocol ID
- DTH: 22003
- Status last verified
- Sep 2022
- First submitted
- 18 Oct 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bipolar Electrosurgery Versus Thermocautery in Circumcision With Safe Anesthetic Techniques
- ClinicalTrials.gov ID
- NCT05590052
- Acronym / sponsor ID
- DTH: 22003
- Conditions
- Circumcision
- Keywords
- Circumcision, Electrosurgery, Thermocautery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Damanhour Teaching HospitalOther government
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 21 Oct 2022 (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.
Background: Circumcision is the most commonly performed surgical procedure done among the pediatric age group worldwide and is considered to be one of the oldest operations done. Circumcision should be performed properly with safe surgical techniques, with the least possibility of complications.
Objective: To compare bipolar electrosurgery versus thermocautery in the circumcision of infants under combined general and local anesthesia.
Patients and Methods: This prospective randomized comparative study was carried out on 110 infants who were candidates for elective circumcision under combined general and local anesthesia. Infants were randomly allocated into two equal groups (55 infants each); in group A, circumcised by bone-cutting forceps with cutting foreskin using a scalpel and achievement of hemostasis using bipolar electrosurgery, and in group B, circumcised by bone-cutting forceps with cutting foreskin and achievement of hemostasis using thermocautery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bipolar Electrosurgery group (n=60) | Active comparator | Device: Bipolar ElectrosurgeryGroup A |
| Thermocautery group (n=60) | Active comparator | Device: ThermocauteryGroup B |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants of families who applied for circumcision
- Age from 1 to 12 months, of the male sex
- Infants should have normal preoperative laboratory investigations
Key exclusion criteria (4 listed)
- Infants with congenital malformations especially hypospadias and epispadias, congenital inguinal hernia, and undescended testis
- Infants with acute penile infection, or excess suprapubic fat
- Infants with cardiovascular, neurological, respiratory, liver, renal, endocrine, blood, or immune diseases
- Allergy to any drug will be used in this study
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 |
|---|---|---|
| Bipolar ElectrosurgeryAchievement of hemostasis using bipolar electrosurgery | Device | Bipolar Electrosurgery group (n=60) |
| Thermocauteryachievement of hemostasis using thermocautery | Device | Thermocautery group (n=60) |
Primary outcome
Mean and Standard deviation of postoperative analgesic doses (mean±SD)
Time frame: 72 hours after the end of the operation
Number of analgesic doses given after the end of the operation
3 secondary outcomes
Mean and Standard deviation of Operative duration (minutes) (mean±SD)
Time frame: 2 minutes after the end of the operation
Number of participants and Rate of Intraoperative complications
Time frame: 2 minutes after the end of the operation
Number of participants and Rate of Postoperative complications
Time frame: 4 weeks after the end of the operation
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 18 Jan 2023.
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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.
Ahmed M Shaat, MD principal investigator
Damanhour Teaching 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 Bipolar Electrosurgery and Thermocautery in people with Circumcision, run by Damanhour Teaching Hospital at 1 site in Egypt.
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 3 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 18 Jan 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 Egypt. 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?
Mean and Standard deviation of postoperative analgesic doses (mean±SD) (time frame: 72 hours after the end of the operation). 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 18 Jan 2023.