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Plastibell Versus Conventional Dissection Techniques for Circumcision in Infants and Children

NCT02587208 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-10-27

No results posted yet for this study

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

Conditions

  • Circumcision, Male

Interventions

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.

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.

Sponsors & Collaborators

  • King Saud University

    lead OTHER

Principal Investigators

  • Abdulrahman Alzahem, MBBS, FRCSC · King Saud University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
12 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-12-31
Completion
2016-03-31

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02587208 on ClinicalTrials.gov