HypospadiasNCT07675798
Effect of Caudal Block on Urethrocutaneous Fistula After Distal Hypospadias Repair
A study testing Caudal Block and General Anesthesia without Caudal Block in people with Hypospadias and Caudal Block, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
Hypospadias is one of the most common congenital urogenital anomalies in males, occurring in approximately 1 in every 200-300 male births. It is characterized by abnormal positioning of the urethral meatus on the ventral surface of the penis. Read more about this study
- Who is it for?
- Ages 6 to 60 months, men only
- Conditions the study is for
- Hypospadias, Caudal Block, Pediatric Anesthesia
- What is being tested?
- Caudal Block and General Anesthesia without Caudal Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 15 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 60 months
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Male patients aged 6-60 months
- Diagnosed with distal hypospadias
- Scheduled for elective hypospadias repair
- Written informed consent obtained from parent or legal guardian
Who cannot join
- Age < 6 months or > 60 months
- Proximal or non-distal hypospadias
- Previous hypospadias repair
- Skin lesions at the epidural/caudal injection site
- Coagulopathy
- Known allergy to anesthetic agents, particularly bupivacaine hydrochloride
Show all 11Show fewer
- Spinal anomalies
- Chronic granulomatous disease
- Diabetes mellitus
- Patients receiving corticosteroid therapy
- Refusal of informed consent by parent or guardian
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Dicle University
Diyarbakır, Eyalet/Yerleşke, 21070
Fikret Salık, 05076214125, fikretsalik@gmail.com
- Recruiting
Gazi Yaşargil Training and Research Hospital
Diyarbakır, Eyalet/Yerleşke, 21070
Mustafa Bıçak, 05320571437, drmustafabicak@gmail.com
About this study
Official title: The Effect of Caudal Block on the İncidence of Urethrocutaneous Fistula After Distal Hypospadias Repair: A Multicentre, Randomized Controlled Trial
Hypospadias is one of the most common congenital urogenital anomalies in males, occurring in approximately 1 in every 200-300 male births. It is characterized by abnormal positioning of the urethral meatus on the ventral surface of the penis. Surgical repair is the standard treatment; however, urethrocutaneous fistula formation remains one of the most frequent and clinically significant postoperative complications, potentially requiring reoperation and causing considerable distress to both the patient and the family.
Caudal nerve block is a widely used regional anesthesia technique in pediatric lower abdominal and genitourinary surgery, valued for its high analgesic efficacy, relative ease of application, and low complication profile. However, emerging evidence suggests that caudal block may be associated with an increased incidence of postoperative complications following hypospadias repair, including fistula formation and wound edema. Notably, Kundra et al. (2012) reported a fistula rate of 19.2% in patients who received caudal block, compared to 0% in those who received penile block, raising important questions about the routine use of caudal block in hypospadias surgery.
This prospective, multicenter, randomized controlled trial aims to evaluate the effect of caudal block on the incidence of urethrocutaneous fistula following distal hypospadias repair. A total of 80 male patients aged 6-60 months will be randomized 1:1 to either receive general anesthesia with caudal block or general anesthesia alone. The primary outcome is the incidence of urethrocutaneous fistula. Secondary outcomes include perioperative opioid consumption, postoperative pain scores, analgesic duration, and other surgical complications such as wound dehiscence and urethral stricture. Patients will be followed up for 3-6 months postoperatively. The study will be conducted across four centers in Turkey. Results are expected to provide evidence-based guidance on the role of caudal block in pediatric hypospadias repair.
Read the detailed description
This is a prospective, multicenter, randomized controlled trial. Eighty male patients aged 6-60 months undergoing distal hypospadias repair will be enrolled across four centers: Dicle University Faculty of Medicine Hospital, Istanbul Başakşehir Çam ve Sakura City Hospital, Diyarbakır Gazi Yaşargil Training and Research Hospital, and Mardin Training and Research Hospital. Patients will be randomized 1:1 using a simple randomization method with sealed envelope allocation into two groups: Group 1 (caudal block + general anesthesia) and Group 2 (general anesthesia alone). Demographic and clinical data, anesthesia and surgery duration, intraoperative and postoperative analgesic use, pain scores, length of hospital stay, and postoperative complications will be recorded. Patients will be followed for 3-6 months postoperatively for fistula formation, wound dehiscence, and urethral stricture. Statistical analysis will be performed using SPSS v22.0; Student t-test, Mann-Whitney U test, Kruskal-Wallis test, and chi-square test will be applied as appropriate. A p value ≤ 0.05 will be considered statistically significant.
- Conditions
- Hypospadias, Caudal Block, Pediatric Anesthesia
- Being tested
- Caudal Block, General Anesthesia without Caudal Block
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caudal BlockProcedure or surgery
General anesthesia combined with caudal block administered prior to distal hypospadias repair. Caudal block is performed using bupivacaine hydrochloride as part of standard institutional analgesic protocol.
General Anesthesia without Caudal BlockProcedure or surgery
General anesthesia alone administered without caudal block for distal hypospadias repair. Intravenous analgesic agents used as per standard institutional protocol.
| Study group | Role | What they receive |
|---|---|---|
| Group 1) Caudal Block Group | Experimental | General anesthesia combined with caudal block administered prior to distal hypospadias repair. Caudal block is performed using bupivacaine hydrochloride as part of standard institutional analgesic protocol. Receives: Procedure: Caudal Block |
| Group 2) Non-Caudal Group | Active comparator | General anesthesia alone administered without caudal block for distal hypospadias repair. Intravenous analgesic agents used as per standard institutional protocol. Receives: Procedure: General Anesthesia without Caudal Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Urethrocutaneous Fistula
Development of urethrocutaneous fistula following distal hypospadias repair, assessed by clinical examination
Measured: up to 3 months
Secondary outcomes (4)
Postoperative Pain Scores
Postoperative pain assessed using age-appropriate pain scales (e.g., Visual Analog Scale or FLACC scale, where higher scores indicate worse pain).
Measured: Up to 24 hours postoperatively
Surgical Complications
Incidence of surgery-related complications
Measured: Up to 3 months
Duration of Effective Analgesia
The time from the completion of the surgical/anesthetic procedure until the patient first requests or requires rescue analgesia.
Measured: Up to 24 hours postoperatively
Total Consumption of Rescue Analgesics
The total amount (mg) of rescue analgesic medications required by the patient during the postoperative period.
Measured: Up to 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Dec 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypospadiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fikret Salık, Dicle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07675798
- Sponsor's protocol ID
- 357/2025
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Caudal Block on the İncidence of Urethrocutaneous Fistula After Distal Hypospadias Repair: A Multicentre, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07675798
- Acronym / sponsor ID
- 357/2025
- Conditions
- Hypospadias, Caudal Block, Pediatric Anesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypospadias is one of the most common congenital urogenital anomalies in males, occurring in approximately 1 in every 200-300 male births. It is characterized by abnormal positioning of the urethral meatus on the ventral surface of the penis. Surgical repair is the standard treatment; however, urethrocutaneous fistula formation remains one of the most frequent and clinically significant postoperative complications, potentially requiring reoperation and causing considerable distress to both the patient and the family.
Caudal nerve block is a widely used regional anesthesia technique in pediatric lower abdominal and genitourinary surgery, valued for its high analgesic efficacy, relative ease of application, and low complication profile. However, emerging evidence suggests that caudal block may be associated with an increased incidence of postoperative complications following hypospadias repair, including fistula formation and wound edema. Notably, Kundra et al. (2012) reported a fistula rate of 19.2% in patients who received caudal block, compared to 0% in those who received penile block, raising important questions about the routine use of caudal block in hypospadias surgery.
This prospective, multicenter, randomized controlled trial aims to evaluate the effect of caudal block on the incidence of urethrocutaneous fistula following distal hypospadias repair. A total of 80 male patients aged 6-60 months will be randomized 1:1 to either receive general anesthesia with caudal block or general anesthesia alone. The primary outcome is the incidence of urethrocutaneous fistula. Secondary outcomes include perioperative opioid consumption, postoperative pain scores, analgesic duration, and other surgical complications such as wound dehiscence and urethral stricture. Patients will be followed up for 3-6 months postoperatively. The study will be conducted across four centers in Turkey. Results are expected to provide evidence-based guidance on the role of caudal block in pediatric hypospadias repair.
Detailed description
This is a prospective, multicenter, randomized controlled trial. Eighty male patients aged 6-60 months undergoing distal hypospadias repair will be enrolled across four centers: Dicle University Faculty of Medicine Hospital, Istanbul Başakşehir Çam ve Sakura City Hospital, Diyarbakır Gazi Yaşargil Training and Research Hospital, and Mardin Training and Research Hospital. Patients will be randomized 1:1 using a simple randomization method with sealed envelope allocation into two groups: Group 1 (caudal block + general anesthesia) and Group 2 (general anesthesia alone). Demographic and clinical data, anesthesia and surgery duration, intraoperative and postoperative analgesic use, pain scores, length of hospital stay, and postoperative complications will be recorded. Patients will be followed for 3-6 months postoperatively for fistula formation, wound dehiscence, and urethral stricture. Statistical analysis will be performed using SPSS v22.0; Student t-test, Mann-Whitney U test, Kruskal-Wallis test, and chi-square test will be applied as appropriate. A p value ≤ 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1) Caudal Block Group | Experimental | Procedure: Caudal BlockGeneral anesthesia combined with caudal block administered prior to distal hypospadias repair. Caudal block is performed using bupivacaine hydrochloride as part of standard institutional analgesic protocol. |
| Group 2) Non-Caudal Group | Active comparator | Procedure: General Anesthesia without Caudal BlockGeneral anesthesia alone administered without caudal block for distal hypospadias repair. Intravenous analgesic agents used as per standard institutional protocol. |
Who may qualify
- Ages
- 6 to 60 months
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male patients aged 6-60 months
- Diagnosed with distal hypospadias
- Scheduled for elective hypospadias repair
- Written informed consent obtained from parent or legal guardian
Key exclusion criteria (11 listed)
- Age < 6 months or > 60 months
- Proximal or non-distal hypospadias
- Previous hypospadias repair
- Skin lesions at the epidural/caudal injection site
- Coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caudal BlockGeneral anesthesia combined with caudal block administered prior to distal hypospadias repair. Caudal block is performed using bupivacaine hydrochloride as part of standard institutional analgesic protocol. | Procedure or surgery | Group 1) Caudal Block Group |
| General Anesthesia without Caudal BlockGeneral anesthesia alone administered without caudal block for distal hypospadias repair. Intravenous analgesic agents used as per standard institutional protocol. | Procedure or surgery | Group 2) Non-Caudal Group |
Primary outcome
Incidence of Urethrocutaneous Fistula
Time frame: up to 3 months
Development of urethrocutaneous fistula following distal hypospadias repair, assessed by clinical examination
4 secondary outcomes
Postoperative Pain Scores
Time frame: Up to 24 hours postoperatively
Surgical Complications
Time frame: Up to 3 months
Duration of Effective Analgesia
Time frame: Up to 24 hours postoperatively
Total Consumption of Rescue Analgesics
Time frame: Up to 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caudal Block and General Anesthesia without Caudal Block in people with Hypospadias and Caudal Block, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fikret Salık, associate professor (+905076214125, fikretsalik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Urethrocutaneous Fistula (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.