Hypospadias is a congenital anomaly with an incidence of 0.4-8.2 per 1000 live births and is the second most common congenital disorder after cryptorchidism in boys. The goal of hypospadias surgery is to create a normal looking straight penis with: comfortable and complete voiding, good and straight stream of urine in upright voiding with no splaying, slit like vertical meatus, absence of torsion and chordee and reduce the risk of complications. Urethrocutaneous fistula (UCF) continues to be a common and frustrating complication after hypospadias repair.

1. COMPARISON OF VICRYL (POLYGLACTIN) VERSUS POLYDIOXANONE (PDS)
SUTURE IN HYPOSPADIAS REPAIR IN TERMS OF URETHROCUTANEOUS
FISTULA DEVELOPMENT: A randomized controlled trial
Institutional Ethical review Committee,
FMU, Faisalabad
Submitted By
Dr. Mujahid Israr Sattar Randhawa
Supervisor
Prof. Dr. Khalid Mahmood
Department
Paediatric Surgery Dept. Allied Hospital
Faisalabad.

2. Background
• Hypospadias is a congenital anomaly with an incidence of 0.4-8.2 per 1000 live births
and is the second most common congenital disorder after cryptorchidism in boys.
• The goal of hypospadias surgery is to create a normal looking straight penis with:
comfortable and complete voiding, good and straight stream of urine in upright voiding
with no splaying, slit like vertical meatus, absence of torsion and chordee and reduce the
risk of complications.
• Urethrocutaneous fistula (UCF) continues to be a common and frustrating complication
after hypospadias repair.

3. • Many studies investigated and compared different suture materials in terms of
urethrocutaneous fistula (UCF) development, and it was found to be a subject of
controversy.
• Both rapid absorbable sutures (polyglactin, Vicryl) and delayed absorbable sutures
(polydioxanone, PDS) are used in hypospadias repair based on the surgeon’s preference.
• This study is designed to compare post-urethroplasty complication rates in children with
hypospadias using Vicryl or PDS sutures in terms of UCF development in patients of
paediatric surgery dept.
Cont.….

4. Rationale
• To compare post-urethroplasty complication in terms of urethrocutaneous fistula (UCF)
in paediatric patients with hypospadias using Vicryl or PDS sutures. The technique with
less complications will be suggested for future use.

5. • To compare vicryl (Polyglactin) versus Polydioxanone (PDS) suture in hypospadias repair
in terms of urethrocutaneous fistula development.
Objectives

6. • Hypospadias:
Hypospadias is a birth defect in which the opening of the urethra is anywhere on the
underside of the penis instead of at the tip.
• Urethrocutaneous Fistula:
Urethrocutaneous fistulas are unwanted openings between the urethra and the
perineum that can cause urine to leak out.
• Chordee:
Chordee is a congenital condition /birth defect resulting from abnormal development
of the penis in which the penis curves downwards, usually in hypospadias.
Operational Definitions

7. Materials & Methods
• Study Design: Randomized Controlled Trial
• Setting: Department of Paediatric Surgery, Allied Hospital Faisalabad.
• Duration: 12 months.
• Sample Size: 96 patients.

8. Inclusion and Exclusion Criteria
Inclusion Criteria
• Subjects in the age range of 1-10 years,
with confirmed diagnosis of Subcoronal
hypospadias with hypospadic morbid
anatomy suitable for surgical repair will be
included in study.
Exclusion Criteria
• Prior hypospadias repairs,
• Pre-surgical testosterone stimulation
• Hypospadias other than subcoronal position
• Underwent hypospadias repair by a
different surgical technique.
• Other urogenital birth defects.

9. • After taking approval from ERC, patients coming from OPD of Paediatric Surgery
Department fulfilling the inclusion criteria will be enrolled.
• Informed consent will be taken.
• Patients will undergo hypospadias repair.
• Follow-up in OPD after 3 weeks, 2nd and 6th month after the operation.
Methodology/Data Collection Procedure

10. • During the visits, the patients will be examined regarding urinary flow and for
complications.
• Data will be noted for variables such as time of diagnosis, presentation, associated
chordee, other associated anomalies, type of surgery, type of suture material, period of
catheterization, hospital stay and post-operative complications-(UCF).
Cont.……

11. • The data will be entered and analyzed in the SPSS version 25.
• Quantitative variable such as age of children, period of catheterization, hospital stay
• Qualitative variables such as associated chordee, number of stages of surgery, suture type
will be measured by using frequency and percentage
• Effect modifiers like age, type of hypospadias, associated chordee will be controlled by
stratification.
• Post stratification chi – square test will be applied to see their effect on outcome.
• P value less than 0.05 will be considered as significant.
Statistical Analysis

12. • ALARABY, S. O. M. A., ABDELJALEEL, I. A., HAMZA, A. A. & ELHASSAN, A. E. E. 2021. A
comparative study of polydioxanone (PDS) and polyglactin (Vicryl) in hypospadias repair.
African Journal of Paediatric Surgery: AJPS, 18, 53.
• CORAN, A. G., CALDAMONE, A., ADZICK, N. S., KRUMMEL, T. M., LABERGE, J.-M. &
SHAMBERGER, R. 2012. Pediatric surgery E-book, Elsevier Health Sciences.
• KERSTEIN, R. L., SEDAGHATI, T., SEIFALIAN, A. M. & KANG, N. 2013. Effect of human urine
on the tensile strength of sutures used for hypospadias surgery. Journal of Plastic,
Reconstructive & Aesthetic Surgery, 66, 835-838.
• KHALID, A., ZAIDI, S. H. & SALEEM, M. B. F. Does the Choice of Suture Material Affect the
Incidence of Urethrocutaneous Fistulae After Hypospadias Repair?–A Comparison of
Polyglactin 910 with Polydioxanone.
References

13. • KURDI, M. O., ELDESSOUKI, N. I. & KHIRALLAH, M. G. 2022. Hybrid Mathieu
Urethroplasty vs. Tubularized Incised Plate Urethroplasty for the Management of Distal
Penile Hypospadias With a Small Glans. Frontiers in Pediatrics, 10.
• SHIRAZI, M., HAGHPANAH, A., DEHGHANI, A., HAGHPANAH, S., GHAHARTARS, M. &
RAHMANIAN, M. 2022. Comparison of post-urethroplasty complication rates in pediatric
cases with hypospadias using Vicryl or polydioxanone sutures. Asian Journal of Urology,
9, 165-169.
• SINGH, A. P., SHUKLA, A. K., SHARMA, P. & BAROLIA, D. K. 2019. Tubularized incised plate
urethroplasty (Snodgrass procedure) for distal penile hypospadias: A regional center
experience. Nigerian Journal of Plastic Surgery, 15, 1.
Cont.….

14. • SINGH, N., WANI, A. H., ISHAR, T., KUMAR, D. & DIGRA, N. C. 2022. Preoperative Factors Affecting the
Outcome of Single Stage Hypospadias Repair-An Observational Study. Annals of International Medical
and Dental Research, 8, 9.
• ULMAN, I., ERIKCI, V., AVANOĞLU, A. & GÖKDEMIR, A. 1997. The effect of suturing technique and
material on complication rate following hypospadias repair. European journal of pediatric surgery, 7,
156-157.
Cont.….