Distal Hypospadias Clinical Trial
Official title:
Incidence of Urethrocutaneous Fistula Following Distal Hypospadias Repair With and Without Caudal Epidural Block - A Pilot Study
| Verified date | October 2020 |
| Source | Sir Ganga Ram Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The study is designed to explore any association between the caudal epidural block(CEB) given for perioperative analgesia and the occurrence of urethrocutaneous fistula postoperatively in children undergoing distal hypospadias repair .We also intend to study the duration of penile engorgement due to CEB causing penile oedema which may subsequently play a role in fistula formation. The pilot study will recruit children under 8 years of age diagnosed with distal hypospadias scheduled to undergo Tubularised Incised Plate Urethroplasty, operated by a single paediatric surgeon. General anaesthesia will be induced with sevoflurane in oxygen nitrous oxide mixture supplemented by fentanyl citrate and atracurium besylate in all children. LMA Pro SealTMof appropriate size will be inserted. Children in group I will then be given caudal epidural block (CEB) as per our practice protocol. Children in group II will be given additional intravenous fentanyl citrate. All children will be followed postoperatively till 3 months to evaluate incidence of urethtocutaneous fistula. The prospective study attempts to eliminate previously reported confounding factors.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | November 28, 2019 |
| Est. primary completion date | November 28, 2019 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 1 Year to 8 Years |
| Eligibility | Inclusion Criteria: 1. Male children l 2. 1 to 8 years of age 3. ASA physical status I and II 4. Distal hypospadias - Exclusion Criteria: 1. Simultaneously undergoing any other procedure 2. Local infection in sacral region 3. Bleeding diathesis 4. Preoperative testosterone stimulation |
| Country | Name | City | State |
|---|---|---|---|
| India | Sir Ganga Ram Hospital | New Delhi | Delhi |
| Lead Sponsor | Collaborator |
|---|---|
| Sir Ganga Ram Hospital |
India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of urethrocutaneous fistula | Patients undergoing distal hypospadias repair will be followed up for occurrence of uretherocutaneous fistula | From one day after surgery(0-hours, baseline) till 3-months post surgery | |
| Secondary | Penile Engorgement | Length of penis from pubic bone to glans tip and mid shaft circumference i.e. girth around the widest part of the penile shaft will be calculated | After induction of anaesthesia (0-hours, baseline) till end of surgery | |
| Secondary | Changes in intra-operative heart rate (beats per minute) | Comparison of intra-operative heart rate between both the arms will be done | From beginning of anesthesia (0-hours, baseline) till 2-hours intraoperatively | |
| Secondary | Change in Intra-operative blood pressure - systolic , diastolic, and mean (mmHg) | Comparison of intra-operative blood pressure- systolic, diastolic, and mean between both the arms will be done | rom beginning of anesthesia (0-hours, baseline) till 2-hours intraoperatively | |
| Secondary | Postoperative analgesia requirement | Additional fentanyl citrate 0.5-mcg/kg will be administered intravenously if the Face, Legs, Activity, Cry, Consolability scale (FLACC scale) score is > 3 and total amount administered will be recorded | From end of anaesthesia (0-hours, baseline) till 24-hours postoperatively | |
| Secondary | Incidence of complications | Complications of surgery such as infection, bleeding , hematoma, glans dehiscence, skin or flap necrosis will be noted | From end of anaesthesia (0-hours, baseline) till 3-months postoperatively |