- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07668973
Comparison Between Excision And Primary Anastomosis Urethroplasty And Tunica Vaginalis Graft Urethroplasty.
21 giugno 2026 aggiornato da: Waqas Ali, Sahiwal medical college sahiwal
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
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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
A proforma will be prepared by researcher and finalized after pre-testing.
The patients admitted in Sahiwal Teaching Hospital, Sahiwal will be assessed by the researcher himself and results will be noted on the proforma.
Patients will be admitted to hospital one day before surgery.
Detailed history of urinary symptoms, sexual function, catheterization, instrumentation, urinary tract infection, 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.
A midline perineal incision will be made in lithotomy position from the perineoscrotal junction to about 1 cm from the anal margin.
Incision will be deepened through the subcutaneous tissue and Colles' fascia to expose the bulbospongiosus muscle.
The bulbospongiosus muscle will be divided in the midline and retracted.
In Group A (Excision and Primary anastomosis urethroplasty) patients, an incision will be made down onto the catheter 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 30 French bougie and the distal urethra will then be spatulated ventrally.
The anastomosis will be done using interrupted sutures of 4-0 polydioxanone (PDS).
While in Group B (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.
Graft outlined on the parietal tunica vaginalis and carefully dissected avoiding injury to the testis or epididymis.
Hemostasis is secured.
The harvested tunica vaginalis graft is placed on a sterile surface with the serosal surface facing upward.
It is then trimmed to the required size.
The graft is kept moist in normal saline until applied to the urethral site.
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 (Mridha et al., 2023).
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 (Siegel et al., 2024).
Ventral urethrotomy is closed over the catheter using absorbable sutures.
A 16 French soft silicone catheter will be kept in place for 2-3 weeks for drainage of urine.
The bulbospongiosus muscle will be closed in the midline using interrupted 3-0 vicryl sutures.
A suction drain is placed in the perineum overlying the muscle, and Colles' fascia is closed using running 3-0 vicryl, followed by skin closure with running 4-0 chromic.
A clear adhesive dressing is placed, and the patient is placed supine.
Per urethral foley catheter will be removed 2-3 weeks after the procedure.
All procedures will be performed by experienced urologists using standardized surgical techniques to ensure consistency.
Postoperative follow-ups will be conducted at scheduled intervals as per the prescribed proforma.
Data will be collected through proforma.
Tipo di studio
Interventistico
Iscrizione (Stimato)
94
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Dr. Riaz ul Haq Professor, FCPS
- Numero di telefono: 0092-40-4502470
- Email: slmcswl@gmail.com
Backup dei contatti dello studio
- Nome: Dr. Adeel Riaz Consultant, MD
- Numero di telefono: 0092-40-4502470
- Email: slmcswl@gmail.com
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Altro: 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).
|
|
Altro: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Stricture Recurrence
Lasso di tempo: 12 months
|
Defined as the presence of a recurrent stricture on retrograde urethrogram (RUG) or the need for any secondary intervention (e.g., dilatation, direct visual internal urethrotomy, or repeat urethroplasty) within 12 months of the initial surgery.
|
12 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Maximum Urine Flow Rate (Qmax)
Lasso di tempo: 12 months
|
The highest rate of urine flow in milliliters per second (mL/s) as measured by uroflowmetry.
The primary analysis will compare the mean change in Qmax postoperatively.
|
12 months
|
|
Erectile Dysfunction
Lasso di tempo: 12 months
|
Erectile dysfunction (ED) has been defined as the inability to attain or maintain penile erection sufficient for successful sexual intercourse.
The severity of erectile dysfunction is often described as mild, moderate, or severe according to International Index of Erectile Function (IIEF5) questionnaire, with a score of 1-7 indicating severe ED, 08-11 moderate ED, 12-16 mild-moderate ED, 17-21 mild ED, and 22-25 no ED.
|
12 months
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 luglio 2026
Completamento primario (Stimato)
1 luglio 2027
Completamento dello studio (Stimato)
1 luglio 2027
Date di iscrizione allo studio
Primo inviato
21 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
21 giugno 2026
Primo Inserito (Effettivo)
25 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
25 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
21 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Malattie genitali
- Disordini mentali
- Malattie genitali, maschio
- Malattie urogenitali maschili
- Malattie urologiche
- Malattie urogenitali femminili
- Malattie urogenitali femminili e complicanze della gravidanza
- Disfunzione sessuale, fisiologica
- Disfunzioni sessuali, psicologiche
- Malattie uretrali
- Ostruzione uretrale
- Disfunzione erettile
- Stenosi uretrale
Altri numeri di identificazione dello studio
- 369/IRB
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Excision and Primary Anastomosis Urethroplasty
-
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