- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07797829
Buccal Mucosal Graft Ureteroplasty for Treatment of Proximal Ureteric Strictures, A Clinical Case Series.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Tidlig fase 1
Kontakter og lokationer
Studiekontakt
- Navn: Mohamed AbdelMawgoud, Assistant lecturer
- Telefonnummer: +201011486957
- E-mail: mo.salah@aun.edu.eg
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Adult patients (age ≥ 18 years) of either sex.
- Confirmed diagnosis of long (>2 cm) upper and middle ureteric strictures, either fresh or recurrent with previous open or endoscopic intervention.
Exclusion Criteria:
- Malignant ureteric stricture or stricture secondary to active pelvic/retroperitoneal malignancy.
- Active urinary tract infection at the time of planned surgery.
- Uncorrected coagulopathy or other contraindication to anesthesia/surgery.
- Active oral mucosal disease, oral submucous fibrosis or previous bilateral grafting.
- Solitary non-functioning kidney on the affected side with differential renal function<15% on renogram (relative or absolute non-functioning renal unit) unless reconstruction is otherwise indicated.
- Pregnancy.
- Cases of ureteric avulsion where ileal ureter substitution will be used or cases with complete ureter obliteration no passing guidewire or ureteric catheter.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Patients with proximal ureteric strictures
|
Ureteric Exposure and Stricturoplasty The affected ureteric segment is approached (open flank) for upper third and Abernathy for middle ureteric stricture. and the stricture is identified and confirmed. The ureter is opened longitudinally (ureterotomy) with no. 11 blade across the full length of the stricture guided by the catheter onto 1 cm of healthy tissue proximally and distally. In short tight areas with maximal narrowing <1 cm, mucosa is excised and mucosa to mucosa anastomosis is done. The prepared BMG is fashioned onto the ureterotomy defect (onlay technique) or configured as an augmentation patch and secured with vicryl 5-0 continuous absorbable sutures over a silicon 6/26 Dj stent. A double-J ureteric stent is placed across the repaired segment prior to completion of the graft inset to splint the reconstruction and ensure adequate drainage during graft take. Omental wrap or peri-ureteric fat/tissue coverage of the graft is performed where feasible to enhance graft vasculariza |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Surgical success defined as ureteric patency without need for re-intervention
Tidsramme: 1 year
|
1 year
|
|
Surgical success defined as ureteric patency without need for re- intervention
Tidsramme: 1 year
|
1 year
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- Nasef AS, Tagrida IAE, Salman MF, Elatreisy A, Khaled SM. Buccal mucosal graft for onlay ureteroplasty in the management of proximal ureteral stricture. Single centre, prospective trial. Arch Ital Urol Androl. 2025 Jun 30;97(2):13695. doi: 10.4081/aiua.2025.13695. Epub 2025 May 15.
- Naude JH. Buccal mucosal grafts in the treatment of ureteric lesions. BJU Int. 1999 May;83(7):751-4. doi: 10.1046/j.1464-410x.1999.00019.x.
- Kocot A, Kalogirou C, Vergho D, Riedmiller H. Long-term results of ileal ureteric replacement: a 25-year single-centre experience. BJU Int. 2017 Aug;120(2):273-279. doi: 10.1111/bju.13825. Epub 2017 Mar 21.
- Lee M, Lee Z, Koster H, Jun M, Asghar AM, Lee R, Strauss D, Patel N, Kim D, Komaravolu S, Drain A, Metro MJ, Zhao L, Stifelman M, Eun DD; Collaborative of Reconstructive Robotic Ureteral Surgery (CORRUS). Intermediate-term outcomes after robotic ureteral reconstruction for long-segment (>/=4 centimeters) strictures in the proximal ureter: A multi-institutional experience. Investig Clin Urol. 2021 Jan;62(1):65-71. doi: 10.4111/icu.20200298. Epub 2020 Nov 12.
- Hefermehl LJ, Tritschler S, Kretschmer A, Beck V, Stief CG, Schlenker B, Strittmatter F. Open ureteroplasty with buccal mucosa graft for long proximal strictures: A good option for a rare problem. Investig Clin Urol. 2020 May;61(3):316-322. doi: 10.4111/icu.2020.61.3.316. Epub 2020 Mar 9.
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 01011486957
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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