Initial Drainage Method and Flexible Ureteroscopy Outcomes in Calculous Anuria
Impact of Initial Drainage Method on Flexible Ureteroscopy Outcomes in Patients Presenting With Calculous Anuria: A Multicenter Prospective Randomized Controlled Trial
Calculous anuria caused by obstructing upper ureteral stones in a solitary functioning kidney is a urological emergency requiring urgent decompression. Both retrograde JJ ureteral stenting and percutaneous nephrostomy are commonly used emergency drainage methods. However, limited evidence is available regarding whether the initial drainage method affects subsequent definitive flexible ureteroscopy/retrograde intrarenal surgery outcomes.
This multicenter prospective randomized controlled trial will compare emergency JJ ureteral stent drainage versus percutaneous nephrostomy drainage in adult patients presenting with calculous anuria due to a single upper ureteral stone in a solitary functioning kidney. After renal functional improvement, clinical stabilization, and appropriate urine culture management, all participants will undergo standardized definitive flexible ureteroscopy/retrograde intrarenal surgery. The study will assess renal functional recovery, first-session surgical success, stone-free rate, operative parameters, complications, and microbiological outcomes.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
This is a multicenter prospective randomized controlled trial comparing two emergency drainage strategies before definitive flexible ureteroscopy/retrograde intrarenal surgery in patients presenting with calculous anuria.
Adult patients with calculous anuria caused by a single upper ureteral stone in a solitary functioning kidney will be assessed for eligibility. Eligible participants will be randomized in a 1:1 ratio to emergency retrograde JJ ureteral stent drainage or emergency percutaneous nephrostomy drainage. Randomization will be performed using a computer-generated random sequence, with allocation concealment using sequentially numbered opaque sealed envelopes.
Participants assigned to the JJ stent group will undergo emergency retrograde placement of a 6 Fr JJ ureteral stent under cystoscopic guidance. Participants assigned to the percutaneous nephrostomy group will undergo emergency ultrasound-guided placement of an 8 Fr nephrostomy tube. After drainage, participants will be monitored for urine output recovery, renal functional improvement, symptom relief, and clinical stabilization.
Definitive flexible ureteroscopy/retrograde intrarenal surgery will be scheduled after renal functional improvement, clinical stabilization, and negative or appropriately treated urine culture. The definitive procedure will be performed using a standardized operative strategy. Ureteral access sheath use, successful insertion, need for adjunctive ureteral maneuvers, operative time, laser time, fluoroscopy time, postoperative stenting, complications, and hospital stay will be recorded.
The primary outcome is renal functional recovery after initial drainage and definitive surgery, assessed using serial serum creatinine measurements at presentation, 24 to 48 hours after drainage, before definitive surgery, postoperative day 1, and follow-up. Secondary outcomes include first-session definitive surgery success, stone-free rate, technical operative variables, intraoperative and postoperative complications, microbiological culture patterns, and predictors of surgical success or postoperative complications.
Participants will be followed for approximately one month after definitive surgery by clinical assessment, laboratory evaluation, and imaging for assessment of renal function, complications, and stone clearance.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Hany F Badawy, MD
- Telefonnummer: +201149525028
- E-Mail: HANYFATHY86@GMAIL.COM
Studienorte
-
-
-
Tanta, Ägypten
- Rekrutierung
- Department of Urology- Tanta University Hospitals
-
Kontakt:
- I, MD
- Telefonnummer: +201060245430
- E-Mail: MMohamed.elmaadawy@med.tanta.edu.eg
-
Hauptermittler:
- I Elmaadawy, MD
-
-
Beni Suweif Governorate
-
Banī Suwayf, Beni Suweif Governorate, Ägypten
- Rekrutierung
- Department of Urology- Beni-Suef University Hospitals
-
Kontakt:
- Hany F Badawy, MD
- Telefonnummer: +201149525028
- E-Mail: HANYFATHY86@GMAIL.COM
-
Hauptermittler:
- Hany F Badawy, MD
-
-
Minya Governorate
-
Minya, Minya Governorate, Ägypten
- Rekrutierung
- Department of Urology- Minia University Hospitals
-
Kontakt:
- M Abdelmalek, MD
- Telefonnummer: +20 11 00464753
-
Hauptermittler:
- M Abdelmalek, MD
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Adults aged 18 years or older.
- Calculous anuria secondary to a single upper ureteral stone.
- Solitary functioning kidney, whether anatomical or functional.
- Single upper ureteral stone confirmed by non-contrast computed tomography.
- Stone size from 6 mm to 20 mm in maximum diameter.
- Patient considered suitable for either initial JJ ureteral stent drainage or percutaneous nephrostomy drainage.
- Candidate for definitive treatment by flexible ureteroscopy/retrograde intrarenal surgery.
- Documented renal functional improvement and clinical stabilization before definitive RIRS.
- Negative or appropriately treated urine culture before definitive RIRS.
- Ability and willingness to provide written informed consent.
Exclusion Criteria:
- Multiple stones or bilateral stones not fitting the solitary-kidney study design.
- Renal pelvic, distal ureteral, or multiple ipsilateral stones.
- Stone burden greater than 20 mm.
- Septic shock, hemodynamic instability, or need for emergency dialysis at presentation.
- Pyonephrosis requiring a non-randomized drainage decision.
- Anatomical abnormalities affecting endoscopic access, such as horseshoe kidney, pelvic kidney, ureterocele, or ureteral stricture.
- Previous ipsilateral ureteral reconstructive surgery.
- Uncorrected coagulopathy.
- Pregnancy.
- Genitourinary malignancy.
- Inability to complete follow-up.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: JJ Ureteral Stent Drainage Group
Participants randomized to this arm will undergo emergency retrograde placement of a 6 Fr double-J ureteral stent under cystoscopic guidance for decompression of calculous anuria caused by a single upper ureteral stone in a solitary functioning kidney.
After renal functional improvement, clinical stabilization, and appropriate urine culture management, definitive flexible ureteroscopy/retrograde intrarenal surgery will be performed according to the standardized study protocol.
|
Retrograde cystoscopic placement of a 6 Fr JJ ureteral stent for initial upper urinary tract decompression in patients presenting with calculous anuria due to a single upper ureteral stone in a solitary functioning kidney.
After renal functional improvement, clinical stabilization, and appropriate urine culture management, participants will undergo standardized definitive flexible ureteroscopy/retrograde intrarenal surgery.
|
|
Aktiver Komparator: Percutaneous Nephrostomy Drainage Group
Participants randomized to this arm will undergo emergency ultrasound-guided placement of an 8 Fr percutaneous nephrostomy tube for decompression of calculous anuria caused by a single upper ureteral stone in a solitary functioning kidney.
After renal functional improvement, clinical stabilization, and appropriate urine culture management, definitive flexible ureteroscopy/retrograde intrarenal surgery will be performed according to the standardized study protocol.
|
Ultrasound-guided placement of an 8 Fr percutaneous nephrostomy tube for initial upper urinary tract decompression in patients presenting with calculous anuria due to a single upper ureteral stone in a solitary functioning kidney.
After renal functional improvement, clinical stabilization, and appropriate urine culture management, participants will undergo standardized definitive flexible ureteroscopy/retrograde intrarenal surgery.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Serum Creatinine From After Initial Drainage to After Definitive RIRS
Zeitfenster: From 24-48 hours after initial drainage to postoperative day 1 after definitive RIRS
|
Serum creatinine will be measured in mg/dL at 24-48 hours after initial drainage and on postoperative day 1 after definitive tratment of stone by retrograde intrarenal surgery.
The primary outcome will compare the change in serum creatinine from the post-drainage value to the post-RIRS value between the JJ ureteral stent drainage group.
|
From 24-48 hours after initial drainage to postoperative day 1 after definitive RIRS
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
First-Session Definitive RIRS Success Rate
Zeitfenster: During the definitive RIRS procedure
|
First-session definitive RIRS success will be defined as successful completion of flexible ureteroscopy/retrograde intrarenal surgery for the target upper ureteral stone in the planned first definitive session without the need to abort the procedure or schedule an additional unplanned definitive stone procedure during the same treatment pathway.
The proportion of participants achieving first-session success will be compared between the JJ ureteral stent drainage group and the percutaneous nephrostomy drainage group.
|
During the definitive RIRS procedure
|
|
Stone-Free Rate After Definitive RIRS
Zeitfenster: 4 weeks after definitive RIRS
|
Stone-free rate will be defined as the proportion of participants with no detectable residual target stone fragment on follow-up non-contrast computed tomography performed 4 weeks after definitive flexible ureteroscopy/retrograde intrarenal surgery.
Stone-free rate will be compared between the JJ ureteral stent drainage group and the percutaneous nephrostomy drainage group
|
4 weeks after definitive RIRS
|
|
During the definitive RIRS procedure
Zeitfenster: During the definitive RIRS procedure
|
Total operative time will be measured in minutes from insertion of the cystoscope or ureteroscope to completion of the definitive flexible ureteroscopy/retrograde intrarenal surgery procedure.
Mean or median operative time will be compared between the JJ ureteral stent drainage group and the percutaneous nephrostomy drainage group.
|
During the definitive RIRS procedure
|
|
Need for Ureteral Stenting After Definitive RIRS
Zeitfenster: At the end of the definitive RIRS procedure
|
The need for postoperative ureteral stent placement after definitive flexible ureteroscopy/retrograde intrarenal surgery will be recorded.
The proportion of participants requiring postoperative stenting will be compared between both drainage groups
|
At the end of the definitive RIRS procedure
|
|
Intraoperative Complications During Definitive RIRS
Zeitfenster: During the definitive RIRS procedure
|
Intraoperative complications will include ureteral mucosal injury, false passage, ureteral perforation, bleeding affecting visualization, and procedure interruption.
The incidence of intraoperative complications will be compared between both drainage groups.
|
During the definitive RIRS procedure
|
|
Postoperative Infectious Complications After Definitive RIRS
Zeitfenster: From definitive RIRS to 4 weeks after definitive RIRS
|
Postoperative infectious complications will include fever greater than 38°C, systemic inflammatory response syndrome, or sepsis after definitive flexible ureteroscopy/retrograde intrarenal surgery.
The incidence of postoperative infectious complications will be compared between both drainage groups.
|
From definitive RIRS to 4 weeks after definitive RIRS
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Ureteral Access Sheath Insertion Success Rate
Zeitfenster: During the definitive RIRS procedure
|
Ureteral access sheath insertion success will be defined as successful placement of a ureteral access sheath during definitive flexible ureteroscopy/retrograde intrarenal surgery without the need for active ureteral dilatation, semirigid ureteroscopy assistance, or abandonment of sheath placement.
The proportion of successful ureteral access sheath insertion will be compared between the JJ ureteral stent drainage group and the percutaneous nephrostomy drainage group.
|
During the definitive RIRS procedure
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Hany F Badawy, MD, Faculty of medicine BeniSuef University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- FMB050526-ANURIA-RIRS
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .