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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02096159
Other study ID # LC/Uro-MF-01
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 2014
Est. completion date June 2023

Study information

Verified date February 2022
Source Ann & Robert H Lurie Children's Hospital of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary purpose of this study is to determine if routine use of prophylactic (preventive) antibiotics after repair of mid-to-distal hypospadias is beneficial.


Description:

Participants in this multicenter, double-blind study are randomized to receive trimethoprim-sulfamethoxazole or placebo for 10 days postoperatively. Short- and intermediate-term results will be published after participants complete 6 months and 5 years of follow-up, respectively.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 93
Est. completion date June 2023
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender Male
Age group N/A to 5 Years
Eligibility Inclusion Criteria: - mid-to-distal shaft hypospadias - single-stage hypospadias repair - length of urethral repair (urethroplasty) less than or equal to 20 mm - placement of an open-drainage urethral stent at the time of hypospadias repair, with intended duration of stenting for 5-10 days post-operatively Exclusion Criteria: - previous hypospadias repair - prior adverse/allergic reaction or other contraindication to trimethoprim-sulfamethoxazole - cross-reactivity of an existing medication with trimethoprim-sulfamethoxazole - any patient condition with elevated risk of infection or adverse outcome from potential infection (e.g., HIV/AIDS, poorly controlled diabetes mellitus or other immunocompromising conditions, congenital heart disease) - use of antibiotics within seven days prior to hypospadias repair - foreskin reconstruction at the time of hypospadias repair - prescription of oral antibiotics other than Study Medication at the time of hypospadias repair

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
trimethoprim-sulfamethoxazole

Other:
placebo


Locations

Country Name City State
Canada The Hospital for Sick Children Toronto Ontario
United States Ann & Robert H Lurie Children's Hospital of Chicago Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago The Hospital for Sick Children

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary postoperative infection UTI; cellulitis/wound infection up to 30 days
Primary wound-healing complications meatal stenosis; urethral stricture; urethrocutaneous fistula; dehiscence; urethral diverticulum up to 5 years
Secondary adverse drug reaction up to 14 days
Secondary C. difficile colitis up to 6 months
See also
  Status Clinical Trial Phase
Completed NCT02752308 - Effectiveness of Caudal Epidural Block on Intraoperative Blood Loss During Hypospadias Repair Phase 2/Phase 3
Completed NCT04239066 - Penile Ischemia for Hypospadias Repair and The Patients and Surgeons Reported Outcomes N/A
Not yet recruiting NCT03698721 - Urothelium Tissue Engineering Using Biopsies From Transurethral Resection of Prostate
Completed NCT03677453 - Interactive Perioperative Teaching Platform (IPTP) N/A
Terminated NCT04826484 - Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel Phase 3
Completed NCT02103712 - Long Term Outcome of Hypospadias Repair
Suspended NCT05093166 - Clinical Trial to Assess the Safety and Efficacy of Investigational Product in Patients Due to Hypospadias Treatment Failure Phase 1/Phase 2
Withdrawn NCT01762007 - The Change of the Detrusor Thickness After Hypospadias Repair - Comparison With the Normal Control Group
Not yet recruiting NCT05569863 - Identification of Hypospadias Parameters Using Digital Photography and Artificial Intelligence
Completed NCT02495090 - Hypospadias and Exome: Identification of New Genes for Familial Hypospadias N/A
Completed NCT04668183 - Ultrasound-guided PNB and DPNB for Pediatric Distal Hypospadias Surgery
Completed NCT01370798 - Local Oestrogen Versus Placebo as Preoperative Treatment in Patients With Severe Hypospadias: Effects on Post-operative Complications Phase 3
Recruiting NCT06417060 - Caudal Anesthesia Versus Local Anesthesia in Hypospadias N/A
Active, not recruiting NCT02861950 - Does Caudal Block Increase the Incidence of Urethrocutaneous Fistula Formation Following Hypospadias Repair in Infants? Phase 4
Not yet recruiting NCT06410482 - Analgesia in Pediatric Hypospadias Surgeries N/A
Terminated NCT02162810 - Effect of Steroids on Post-Operative Complications Following Proximal Hypospadias Repair N/A
Recruiting NCT05837000 - Dexmedetomidine, Ketamine and Magnesium Sulphate in Caudal Block for Hypospadias Repair Phase 4
Recruiting NCT05319782 - Long-term Assesment of Patients Operated for Hypospadias in Their Childhood : Urinary, Aesthetical, Sexual and Psycho-social Consequences N/A
Recruiting NCT05032222 - The Role of "Hypospadias Objective Scoring Evaluation" (HOSE) and Uroflowmetry in Evaluation of Successful Hypospadias Repair
Completed NCT05144659 - Evaluation of Double Faced Transverse Preputial Onlay Island Flap for Hypospadias Repair in Pediatrics N/A