Plastibell Versus Conventional Dissection Techniques for Circumcision in Infants and Children

NCT02587208 | Unknown DMC

• 1 other identifier: E14-1270
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Circumcision, Male

Keywords

circumcision; plastibell; infants; open sleeve

Outcome Measures

Primary Outcomes (1)

• Questionnaire for Parental satisfaction (overal esthetic outcome)

  \- Parental satisfaction ( overall esthetic outcome \[ very much satisfied, very satisfied, rather, a little satisfied, not at all satisfied\])

  3-6 months

Secondary Outcomes (3)

• Visual Analog Scale (VAS) for Postoperative pain measures

  1-2 weeks

• Early composite morbidity (incidence % and mean duration)

  2-4 weeks

• Likert -type 5-point scale for Parental concerns about early composite morbidity

  2-4 weeks

Study Arms (2)

conventional sleeve

ACTIVE COMPARATOR

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

plastibell

ACTIVE COMPARATOR

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

Interventions

Plastibell DEVICE

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.

plastibell

conventional sleeve PROCEDURE

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.

conventional sleeve

Eligibility Criteria

• Age: 3 Months - 12 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• King Saud University: lead

Study Sites (1)

King Saud University

Riyadh, Riyadh Region, 11472, Saudi Arabia

RECRUITING

Study Officials

• Abdulrahman Alzahem, MBBS, FRCSC

  King Saud University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdulrahman Alzahem, MBBS, FRCSC

CONTACT

+966114695277; aalzahem@ksu.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 30, 2015
• First Posted: October 27, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: October 27, 2015

Record last verified: 2015-10

Locations

SA (1)