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Plastibell Versus Conventional Dissection Techniques for Circumcision in Infants and Children

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ClinicalTrials.gov Identifier: NCT02587208
Recruitment Status : Unknown
Verified October 2015 by Dr Abdulrahman Alzahem, King Saud University.
Recruitment status was:  Recruiting
First Posted : October 27, 2015
Last Update Posted : October 27, 2015
Sponsor:
Information provided by (Responsible Party):
Dr Abdulrahman Alzahem, King Saud University

Brief Summary:

Outcome of circumcision with Plastibell or conventional dissection techniques in infants and children: A prospective randomized controlled trial

Aim: to evaluate and compare postoperative and esthetic outcomes after Plastibell and conventional dissection circumcision

Methods:

Randomized Controlled Trial Inclusion criteria: patients younger than 13 years including neonates who required circumcision for various indications.

Exclusion criteria: - patients with bleeding or clotting disorders

  • Those whose parents insisted on a particular type of surgery
  • Children with lateral- lateral diameter of the glans over which a Plastibell device could not be placed Primary endpoint: parental concerns and satisfaction (questionnaire) Secondary endpoints: composite morbidity, operative time, postoperative pain (analgesic requirements)
  • Early postoperative problems: infection, bleeding, swelling, dysuria, pain (incidence, mean duration, emergency care if necessary, parental concerns about them (on a Likert-type 5-point scale [ not at all, a little, rather, very, very much])
  • Irregular scar, jumbling of tissues at the site of frenulum (assessed by physician)
  • Postoperative adhesions (assessed by physician)
  • Postoperative pain and analgesic requirements (paracetamol 15 mg/kg PO Q6 hrs for 48 hrs then PRN) number of doses and days required for analgesia as judged by parents, VAS ( >- 6 SCORE ), Kaplan-Meier analysis (time to event)
  • Parental satisfaction ( overall esthetic outcome [ very much satisfied, very satisfied, rather, a little satisfied, not at all satisfied])
  • Parental satisfaction ( skin removal): excess skin removal, insufficient skin removal [ not at all, a little, rather, very, very much]
  • Time for bell separation (mean +-SD), Kaplan-Meier analysis for different age groups

Condition or disease Intervention/treatment Phase
Circumcision, Male Device: Plastibell Procedure: conventional sleeve Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Plastibell Versus Conventional Dissection Techniques for Circumcision in Infants
Study Start Date : January 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : March 2016

Arm Intervention/treatment
Active Comparator: conventional sleeve
In the sleeve dissection group, a double incision technique on both outer and inner layers of the foreskin is employed. Hemostasis is achieved by bipolar diathermy, and cut edges are sutured with 5/0 rapide vicryl.
Procedure: conventional sleeve
In the sleeve dissection group, a double incision technique on both outer and inner layers of the foreskin is employed. Hemostasis is achieved by bipolar diathermy, and cut edges are sutured with 5/0 rapide vicryl.

Active Comparator: plastibell
In the Plastibell group, the size of the device is chosen according to the lateral-lateral diameter of the glans. A dorsal slit incision is made and then the foreskin is pulled up and the Plastibell device placed between the prepuce and the glans. A non-absorbable string was tightly tied around the device and the distal prepuce is removed.
Device: Plastibell
In the Plastibell group, the size of the device is chosen according to the lateral-lateral diameter of the glans. A dorsal slit incision is made and then the foreskin is pulled up and the Plastibell device placed between the prepuce and the glans. A non-absorbable string was tightly tied around the device and the distal prepuce is removed.




Primary Outcome Measures :
  1. Questionnaire for Parental satisfaction (overal esthetic outcome) [ Time Frame: 3-6 months ]
    - Parental satisfaction ( overall esthetic outcome [ very much satisfied, very satisfied, rather, a little satisfied, not at all satisfied])


Secondary Outcome Measures :
  1. Visual Analog Scale (VAS) for Postoperative pain measures [ Time Frame: 1-2 weeks ]
    VAS ( >6/10) score would entitle giving paracetamol for patient and the total doses/total days where paracetamol was needed will be calculated

  2. Early composite morbidity (incidence % and mean duration) [ Time Frame: 2-4 weeks ]
    Early postoperative problems: infection, bleeding, swelling, dysuria, pain (incidence, mean duration, emergency care if necessary

  3. Likert -type 5-point scale for Parental concerns about early composite morbidity [ Time Frame: 2-4 weeks ]
    parental concerns about them (on a Likert-type 5-point scale [not at all, a little, rather, very, very much])



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Ages Eligible for Study:   3 Months to 12 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients 3 months - 12 years (inclusive) who required circumcision for various indications.

Exclusion Criteria:

  • Patients with bleeding or clotting disorders
  • Those whose parents insisted on a particular type of surgery
  • Children with lateral- lateral diameter of the glans over which a Plastibell device could not be placed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02587208


Contacts
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Contact: Abdulrahman Alzahem, MBBS, FRCSC +966114695277 aalzahem@ksu.edu.sa

Locations
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Saudi Arabia
King Saud University Recruiting
Riyadh, Saudi Arabia, 11472
Contact: Abdulrahman M Alzahem, MBBS, FRCSC       aalzahem@ksu.edu.sa   
Sponsors and Collaborators
King Saud University
Investigators
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Principal Investigator: Abdulrahman Alzahem, MBBS, FRCSC King Saud University
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Responsible Party: Dr Abdulrahman Alzahem, Associate professor, King Saud University
ClinicalTrials.gov Identifier: NCT02587208    
Other Study ID Numbers: E14-1270
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: October 27, 2015
Last Verified: October 2015
Keywords provided by Dr Abdulrahman Alzahem, King Saud University:
circumcision
plastibell
infants
open sleeve