Circumcision, Male clinical trials

Plastibell Versus Conventional Dissection Techniques for Circumcision in Infants and Children

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