Plastibell Versus Conventional Dissection Techniques for Circumcision in Infants and Children

October 24, 2015 updated by: Dr Abdulrahman Alzahem, King Saud University

Plastibell Versus Conventional Dissection Techniques for Circumcision in Infants

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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:

A balanced, parallel group, prospective randomized controlled trial is to be performed over 2 years at our institute. Patients enrollment will commence after approval of our institutional review board as well as obtaining informed consent from the patient's legal guardians.

Participants Inclusion criteria: Patients younger than 13 years including neonates who required circumcision for various indications.

Exclusion criteria: - Patients with bleeding or clotting disorders

  • Patients with hypospadias or other penile anomalies
  • 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 Interventions The subjects will be randomized and allocated into two groups: the Plastibell and sleeve dissection techniques.

Sample size calculation Power calculation was based on aesthetic outcome which was based on previous studies (Nagdeve et al and Fraser et al) wherein 60-69% of subjects operated by Plastibell technique and 43-45% by conventional dissection technique had good satisfaction. Establishing alpha at 0.2 and a power of 0.80 produced a sample size of 50 patients per arm.

Assignment and randomization A block randomization scheme will be used with equal allocation of subjects to the Plastibell and sleeve dissection groups. There are a total of 10 blocks, each having 10 subjects. One block will be selected by simple random sampling and its subjects will be subjected to the intervention.

Protocol All the parents will be informed regarding details of surgery, complications, postoperative care and follow-up protocol. Both procedures are performed under light general anesthesia and either dorsal penile nerve block or caudal block. The first step in both groups is to separate the foreskin from the glans penis and removal of smegma.

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.

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.

All patients will be managed on a day-care basis. At discharge, they will be prescribed syrup/tablet paracetamol 15mg/kg/dose every 6 hours whenever needed if pain score >_6 based on a visual analog scale for pain assessment. Parents will be told to write down how many times they give analgesic each day until the first postoperative visit.

Follow-up will be done at 14th (or after separation of Plastibell whichever later) and 90th days after surgery.

Written questionnaires will be given to parents at time of discharge 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 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

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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])
3-6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1-2 weeks
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
2-4 weeks
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])
2-4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Saud University

Investigators

  • Principal Investigator: Abdulrahman Alzahem, MBBS, FRCSC, King Saud University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

August 30, 2015

First Submitted That Met QC Criteria

October 24, 2015

First Posted (Estimate)

October 27, 2015

Study Record Updates

Last Update Posted (Estimate)

October 27, 2015

Last Update Submitted That Met QC Criteria

October 24, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • E14-1270

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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