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NCT07668973
Comparison Between Excision And Primary Anastomosis Urethroplasty And Tunica Vaginalis Graft Urethroplasty.
Conditions: Urethral Stricture, Erectile Dysfunction
Sex: Male
Ages: 18 Years – 50 Years
Healthy volunteers: No
Phase: NA
Enrollment: 94
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 \
Eligibility Criteria
Inclusion Criteria:
* Patients with diagnosis of bulbar urethral stricture upto 2cm in length.
* Patients aged between 18-50 years.
* Patients with non-traumatic bulbar urethral stricture.
* Isolated short (≤ 2 cm) bulbar urethral stricture
* Patient is able and willing to comply with the postoperative protocol.
Exclusion Criteria:
* Urethral stricture which is completely obliterated stricture.
* Patients with history of hypospadias or previous open urethral surgery.
* Patients with uncontrolled diabetes or Immunocompromised patients.
* Patients unwilling for the follow-up.
* History of pelvic radiation therapy
* Patient with history of urethral instrumentation in last 3 months.
* Lichen sclerosus related strictures.
* Patients with history of erectile dysfunction, priapism or treatment to enhance erectile function.
Source: ClinicalTrials.gov (NCT07668973). StuddyBuddy aggregates publicly available trial information.