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The effect of double nappy technique on acute complications of urethroplasty

A Comparative study on Effect of two Types of Urine drainage cares (Open/closed system) on acute complications after Hypospadias repair in 6-36 months old children

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014010816142N1
Enrollment
108
Registered
2014-02-03
Start date
2010-12-26
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypospadias. Hypospadias, penile

Interventions

Intervention 1: Intervention group with open urine drainage care (double nappy care method) after-surgery, the following procedure has been used: 1-In the central area of the first diaper a 3 by 3 cm
Prevention
Intervention group with open urine drainage care (double nappy care method) after-surgery, the following procedure has been used: 1-In the central area of the first diaper a 3 by 3 cm two intersectin
Control group, with close urine drainage care after surgery the following procedure has been used : the dripping stent has been attached to a urine bag and it was fixed by hanger bar on railing's bed.

Sponsors

Vice chancellor for Research Shahid Beheshti University Medical Scieneces
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
No minimum to 3 Years

Inclusion criteria

Inclusion criteria: Criteria for inclusion: Being diagnosed with mid-shaft and distal hypospadias; Age between 6-36 months; Underwent the TIP procedure (Tubularized Incised Plate Urethroplasty); Parental consent Criteria for exclusion: Age below 6 month or older than 36 month; other than TIP procedure; Being diagnosed with hypospadias other than mid-shaft and distal; Accompanied by other diseases (Kidney disease, Diabetes Mellitus, coagulation defects, immune deficiency); Parents did not consent

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Removal of catheter by patient. Timepoint: every 3h for 7 days. Method of measurement: observations are recorded in patient’s information sheet.;Level of child restlessness. Timepoint: every 3h for 7 days. Method of measurement: determined by amount of analgesics received and recorded patient’s information sheet.;Catheter irrigation if needed. Timepoint: if needed. Method of measurement: observed and recorded in patient’s information sheet.;Patency of the new urethra. Timepoint: every 3h for 7 days. Method of measurement: observations are recorded in patient’s information sheet.;Urine volume over 24h. Timepoint: every 3h for 7 days. Method of measurement: observations are recorded in patient’s information sheet.;Urinary tract infection. Timepoint: befor surgery and after removal of catheter. Method of measurement: urine calture and recorded in patient’s information sheet.;Wound dehiscence. Timepoint: daily for 7 days. Method of measurement: observed and recorded in patient’s information sheet.;Edima and bleeding in surgical site. Timepoint: every 3h for 7 days. Method of measurement: observed and recorded in patient’s information sheet.;Wound infection in surgical site. Timepoint: daily for 7 days. Method of measurement: observed and recorded in patient’s information sheet.

Secondary

MeasureTime frame
Strictures. Timepoint: at the time of catheter removal, one month, three month, six month after surgery. Method of measurement: observations are recorded in patient’s information sheet.;Fistulas. Timepoint: at the time of catheter removal one month, three month, six month after surgery. Method of measurement: observations are recorded in patient’s information sheet.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMarzieh Fatemian

shahid Beheshti University of Medical Sciences

fatemian.marzieh@gmail.com fatemian_marzieh@yahoo.com+98 21 2290 9575

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026