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Comparison Between Excision And Primary Anastomosis Urethroplasty And Tunica Vaginalis Graft Urethroplasty.
Sponsor: Sahiwal medical college sahiwal
Summary
Urethroplasty is considered as a gold standard in treatment of urethral stricture disease having success rate of more than 93% in terms of recurrence of stricture. The objective of the study is to compare the outcome between excision and primary anastomosis (EPA) urethroplasty, a transecting urethroplasty technique and Tunica Vaginalis Graft (TVG) Urethroplasty, a non-transecting urethroplasty technique, in patients with bulbar urethral stricture upto 2cm in length. It will be a Randomized Controlled Trial (RCT) in which 94 patients admitted in Sahiwal Teaching Hospital, Sahiwal will be included. The patients will be divided into two equal groups. Randomization will be performed using a computer-generated random sequence. The Group-A patients will undergo excision and primary anastomosis (EPA) urethroplasty while Group-B patients will undergo Tunica Vaginalis Graft (TVG) Urethroplasty. Non-probability convenience sampling will be carried out. Detailed history of urinary symptoms, Sexual function, catheterization, instrumentation, urinary tract infection and trauma will be taken to obtain the cause of stricture. Demographic information like name, age, and contact number will be recorded. Investigations will include preoperative complete blood count, renal function test, liver function test, urine complete examination, ultrasonogram kidney, ureter and bladder with post void residual volume (PVR) uroflowmetry and retrograde urethrogram for diagnosis and length of stricture. Other parameters of study will be length of hospital stay, postoperative complication such as graft failure, wound infection, urinary tract infection and fistula formation. Data will be collected through proforma, which will be entered and analyzed using statistical package for social sciences version 26.0. For quantitative variables mean and standard deviation will be calculated and for qualitative variables frequency and percentages will be calculated. Data will be presented in tables and graphs for both quantitative and qualitative variables. Chi-square test will be used to estimate the association between qualitative variables. An Independent sample t-test will be applied for quantitative variables. P-value \<0.05 will be considered significant. It is anticipated that the Tunica Vaginalis Graft (TVG) Urethroplasty provides better outcome as compared to excision and primary anastomosis (EPA) urethroplasty.
Official title: Comparison of Outcome Between Excision and Primary Anastomosis Urethroplasty and Tunica Vaginalis Graft Urethroplasty in Patients With Bulbar Urethral Stricture Upto 2cm in Length : A Randomized Controlled Trial
Key Details
Gender
MALE
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
94
Start Date
2026-07
Completion Date
2027-07
Last Updated
2026-06-25
Healthy Volunteers
No
Conditions
Interventions
Excision and Primary Anastomosis Urethroplasty
In Excision and Primary anastomosis urethroplasty patients, an incision will be made down onto the urethra at the level of stricture in the ventral midline. Urethra will be divided with scissors proximally and distally until healthy urethra is entered. Stay sutures will be placed. The scarred urethra will be excised, and the healthy proximal urethral segment will be spatulated dorsally so that it accommodates a 30Fr bougie and the distal urethra will then be spatulated ventrally. The anastomosis will be done using interrupted sutures of 4-0 polydioxanone (PDS).
Tunica Vaginalis Graft Urethroplasty
In Tunica Vaginalis Graft Urethroplasty patients, an incision will be made onto the urethra in the ventral mid-line along the stricture length, opening into healthy proximal and distal urethra and stay sutures will be positioned. Tunica vaginalis graft is harvested by making a small vertical or transverse hemiscrotal incision. The dartos fascia is divided to expose the tunica vaginalis. The testis is gently delivered through the incision.The tunica vaginalis graft outlined and harvested. The tunica vaginalis defect is approximated and testis is placed back into the scrotum. The dartos and skin are closed in layers using absorbable sutures. The graft will be laid as a ventral onlay graft onto the opened urethral defect and sutured to the urethral mucosal edges using absorbable sutures. Quilting or anchoring sutures may be placed to reduce graft dead space and enhance take. Ventral urethrotomy is closed over the catheter using absorbable sutures.