Skip to main content
Clinical Trials/CTRI/2022/12/048556
CTRI/2022/12/048556Not yet recruitingNot Applicable

A comparative study on the uroflowmetry parameters between single stage and staged hypospadias repair.

Dept of Pediatric Surgery, AIIMS Raipur1 site in 1 country30 target enrollmentStarted: February 1, 2023Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
OBJECTIVE

Study Overview

Brief Summary

Hypospadiasis defined as the opening of meatus on the ventral side of the shaft of thepenis. Until today there are more than 300 different surgical techniques withseveral modifications. Urethral stricture, urethral stenosis, urethrocutaneousfistula, chordee, are some of the few delayed complications after hypospadiassurgery. Urethral stenosis is a common complication and can lead to long termeffects on the bladder which can even potentially end in chronic kidneydisease. Uroflowmetry is a simple easy to use noninvasive test which can beused for the early diagnosis of urethral stenosis / stricture emerging afterhypospadias. Usually in staged hypospadias repair there is long length ofneourethra created. It can provide resistance to urine flow compared to smalllength in single stage hypospadias repair. We in this study aim to compare theuroflowmetry parameters after single stage and staged hypospadias surgery donein our institute. We also propose to find out any difference in theuroflowmetry values in the follow-up of hypospadias operated as single stageand staged repair.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
1.00 Year(s) to 14.00 Year(s) (—)
Sex
Male

Inclusion Criteria

  • All patients undergoing single stage and staged hypospadias repairs during the study period.

Exclusion Criteria

  • Failed repair (glans dehiscence)
  • Urethrocutaneous fistula
  • Patients operated outside the study setting at any point
  • Patients referred to our institute for complications •Preexisting neurological bladder •Meatal Stenosis.

Outcomes

Primary Outcomes

OBJECTIVE

Time Frame: Outcome is assessed at the end of study period. 18 Months from the beginning of study.

Perform uroflowmetry test on study subjects on Day10, Day 30 and Day 60 after removal of catheter.

Time Frame: Outcome is assessed at the end of study period. 18 Months from the beginning of study.

Compare the uroflowmetry parameters between two study groups - single stage and staged hypospadias repair

Time Frame: Outcome is assessed at the end of study period. 18 Months from the beginning of study.

Analyze the results of the comparative study and find out if any statistical difference in uroflowmetry parameters between two study groups.

Time Frame: Outcome is assessed at the end of study period. 18 Months from the beginning of study.

Study if there is any change - either improvement or deterioration of parameter values in course of time.

Time Frame: Outcome is assessed at the end of study period. 18 Months from the beginning of study.

Secondary Outcomes

  • NA(NA)

Investigators

Sponsor
Dept of Pediatric Surgery, AIIMS Raipur
Sponsor Class
Government medical college

Study Sites (1)

Loading locations...

Similar Trials