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Trial registered on ANZCTR


Registration number
ACTRN12616000190404
Ethics application status
Approved
Date submitted
24/12/2015
Date registered
12/02/2016
Date last updated
12/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison between different circumcision techniques in neonates and infants
Scientific title
Comparison of post-operative pain between the Bone Cutter with Thermal Cautery, Gomco and Plastibell for Circumcision in Neonates and Infants: A prospective randomized trial
Secondary ID [1] 288216 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
circumcision 297124 0
Condition category
Condition code
Surgery 297360 297360 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
three different techniques were used for circumcision:
Group 1: Bone Cutter with Thermal Cautery... the technique started by holding the skin by two hemostat was done to elevate the foreskin then application of the bone cutting forceps at the level of skin to be removed for circumcision. Cutting the excess foreskin was done using the heated thermal cautery. the skin was retracted proximally after cutting the excess foreskin to expose the glans. it usually takes 3-5 minutes.
Group 2: will be circumcised using Gomco clamp. the procedure involves placement of special metal device formed of 2 parts; the first one cover the glans to protect it and the second one applied pressure at the line of supposed to be incised then removal of the excess skin was done. it usually takes 5-10 minutes.
Group 3: will be circumcised using Plastibell device. its use involves the placement of a clear plastic ring over the glans, followed by trimming of the excess skin during a surgical procedure, and the device falls off within 3 to 7 days.
Intervention code [1] 293510 0
Treatment: Surgery
Intervention code [2] 293865 0
Treatment: Devices
Comparator / control treatment
control group is circumcised using bone cutting forceps and heat cautery (Group 1)
Control group
Active

Outcomes
Primary outcome [1] 296913 0
postoperative pain:
Postoperative analgesia (Acetaminophen 40 mg/kg/dose) was prescribed only on demand if the baby was continuously crying and refusing feeds.
parents were told to record how many times they gave analgesic each day for the first three days separately, and then, if there was still need for analgesia after these three days until the first postoperative clinic visit 1 week later.
Timepoint [1] 296913 0
1 week
Secondary outcome [1] 319685 0
cosmetic outcome
will be done by a blinded peer assessment by evaluating 4 items
1- Glans ulceration or injury (Absent or Present)
2- Length of mucosal cuff (3 – 5 mm or < 3mm or > 5mm)
3- Length of penile shaft skin (Appropriate or Excess skin or under skin)
4- Peno-scrotal & peno-pubic angles (Preserved or not preserved)

Timepoint [1] 319685 0
4 weeks
Secondary outcome [2] 320646 0
postoperative complications e.g. bleeding, infection, urinary retention
by reviewing the medical records
Timepoint [2] 320646 0
1 week
Secondary outcome [3] 320647 0
parent satisfaction
it will be assessed by asking the parent to give a score from 0 to 4
Parent satisfaction score Interpretation:
0 Unacceptable
1 Bad
2 Fair
3 Good
4 Excellent
Timepoint [3] 320647 0
1 month
Secondary outcome [4] 320648 0
intraoperative details; operative time in minutes, intraoperative bleeding, glans injury (composite secondary outcome)
assessment was done by reviewing the records of the operative notes.
Timepoint [4] 320648 0
at the time of the procedure

Eligibility
Key inclusion criteria
Babies presented for routine circumcision
Minimum age
1 Days
Maximum age
90 Days
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Bleeding tendency
Liver diseases
Neurological impairment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7486 0
Egypt
State/province [1] 7486 0
Cairo

Funding & Sponsors
Funding source category [1] 292603 0
University
Name [1] 292603 0
Ain shams university
Address [1] 292603 0
Ain Shams University Hospitals, 56 Ramsis st., El-Abbasia, Cairo, Egypt (postal code: 11566)
Country [1] 292603 0
Egypt
Primary sponsor type
University
Name
Ain shams university
Address
Ain Shams University Hospitals, 56 Ramsis st., El-Abbasia, Cairo, Egypt (postal code: 11566)
Country
Egypt
Secondary sponsor category [1] 291320 0
None
Name [1] 291320 0
Address [1] 291320 0
Country [1] 291320 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294084 0
Ethical committee of pediatric surgery department of Ain Shams University
Ethics committee address [1] 294084 0
Ain Shams University Hospitals, 56 Ramsis st., El-Abbasia, Cairo, Egypt (postal code: 11566)
Ethics committee country [1] 294084 0
Egypt
Date submitted for ethics approval [1] 294084 0
01/10/2013
Approval date [1] 294084 0
11/11/2013
Ethics approval number [1] 294084 0

Summary
Brief summary
this prospective randomized trial was conducted on 150 babies presented for routine circumcision. They were randomized and equally allocated into 3 groups; babies circumcised using the bone cutter forceps with thermal cautery (Group I), Gomco clamp 'Registered Trademark' (Group II) and the Plastibell device 'Registered Trademark' (Group III). Intraoperative details, postoperative pain and complications, cosmetic outcome, and parent satisfaction were recorded
Trial website
Trial related presentations / publications
Abdel Hay S. The Use of Thermal Cautery for Male Circumcision. JKAU: Med. Sci. 2009; 16(1): 89-93.
Taeusch HW, Martinez AM, Partridge JC, et al. Pain during Mogen or Plastibell circumcision. J Perinatol 2002;22(3):214-218
Public notes

Contacts
Principal investigator
Name 62390 0
Dr Khaled El-Asmar
Address 62390 0
pediatric surgery department, Ain Shams University
14 Mostafa Sadek El-Rafeay, Heliopolis, Cairo, Egypt (postcode 11361)
Country 62390 0
Egypt
Phone 62390 0
+201001222624
Fax 62390 0
Email 62390 0
Khaled80@hotmail.com
Contact person for public queries
Name 62391 0
Dr Khaled El-Asmar
Address 62391 0
pediatric surgery department, Ain Shams University
14 Mostafa Sadek El-Rafeay, Heliopolis, Cairo, Egypt (postcode 11361)
Country 62391 0
Egypt
Phone 62391 0
+201001222624
Fax 62391 0
Email 62391 0
khaled80@hotmail.com
Contact person for scientific queries
Name 62392 0
Dr Khaled El-Asmar
Address 62392 0
pediatric surgery department, Ain Shams University
14 Mostafa Sadek El-Rafeay, Heliopolis, Cairo, Egypt (postcode 11361)
Country 62392 0
Egypt
Phone 62392 0
+201001222624
Fax 62392 0
Email 62392 0
khaled80@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary