Optimal Duration of Urinary Catheterization After Right-Sided Colectomy
Optimal Duration of Urinary Catheterization After Right-Sided Colectomy: Prospective, Randomized, Non-inferiority Trial
The goal of this prospective, randomized trial is to determine the optimal duration of urinary catheterization in patients that receive elective, right-sided colectomy. The main objectives of this study are:
- To compare rates of urinary retention in patients with post operative urinary catheter duration of 0 days and 1 day following right-sided colectomy.
- To compare rates of urinary tract infection (UTI) in patients with postoperative urinary catheter duration of 0 days and 1 day following right-sided colectomy.
Enrolled participants will be randomized to one of two groups, immediate removal of urinary catheter at the conclusion of the operation or removal of urinary catheter on post operative day one.
Přehled studie
Postavení
Podmínky
Detailní popis
Urinary catheterization is indicated for various operations conducted by colorectal surgeons. This process allows a tube to be inserted into the bladder to provide decompression while the patient is anesthetized. Prolonged urinary catheter placement is associated with urinary retention, urinary tract infections, and increased hospital length of stay. Clinical guidelines recommend urinary catheter discontinuation within 24 hours of operation but there is mixed evidence to support this recommendation. Further, there is a paucity of data that investigates optimal urinary catheter duration in specific colorectal surgery operations.
This prospective, randomized clinical trial aims to identify the optimal urinary catheter duration for patients undergoing elective, right-sided colectomy. Patients will be randomized into two groups: 1) urinary catheter discontinuation at the completion of surgery, or 2) urinary catheter discontinuation on post operative day 1. The primary objective is to compare rates of urinary retention between groups. The investigators hypothesize that patients with immediate urinary catheter discontinuation will have reduced rates of urinary retention and urinary tract infections compared to the group with urinary catheters maintained until post operative day 1.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Sacha Broccard, MD
- Telefonní číslo: 201-675-8256
- E-mail: Sacha.Broccard@med.usc.edu
Studijní místa
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California
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Los Angeles, California, Spojené státy, 90033
- Keck Medical Center of USC
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Kontakt:
- Annabah Glasser, MD
- Telefonní číslo: 201-675-3256
- E-mail: Annabah.Glasser@med.usc.edu
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Los Angeles, California, Spojené státy, 90033
- Los Angeles General Medical Center
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Kontakt:
- Annabah Glasser, MD
- Telefonní číslo: 201-675-8256
- E-mail: Annabah.Glasser@med.usc.edu
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Age 18 years or older.
- Scheduled for elective ileocecectomy, right hemicolectomy, or extended right hemicolectomy using an open, laparoscopic, or robotic approach.
- American Society of Anesthesiologists physical status class I-III.
- Ability and willingness to provide written informed consent.
Exclusion Criteria:
- History of urinary tract malignancy.
- Emergent or urgent surgery.
- Right hemicolectomy performed with another major surgical procedure on the same day.
- Genitourinary tract injury during surgery that precludes participation.
- History of urinary retention following a previous procedure, surgery, or urinary catheter removal.
- History of urinary retention that is not being actively treated.
- Neurogenic bladder.
- Chronic indwelling Foley catheter or suprapubic catheter.
- History of cystectomy or a surgically created urinary conduit, including a neobladder or ileal conduit.
- Chronic kidney disease greater than stage 2.
- History of chronic urinary tract infection.
- Current extravesicular or enterourethral fistula.
- Perioperative epidural catheter placement.
- Incarceration.
- Inability or unwillingness to provide informed consent.
- Pregnancy.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Immediate Catheter Removal
Participants will undergo urinary catheter removal immediately after completion of surgery, in the operating room on post operative day 0. |
Removal of the urinary catheter immediately after elective right hemicolectomy before leaving the operating room.
Ostatní jména:
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Aktivní komparátor: Postoperative Day 1 Catheter Removal
Participants will undergo urinary catheter removal on post operative day 1. |
Removal of the intra-operatively placed Foley urinary catheter on the day after elective right-sided colectomy, post-operative day one.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Percentage of Participants With Post Operative Urinary Retention
Časové okno: From initial post operative urinary catheter removal through hospital discharge, assessed up to 90 days.
|
Post operative urinary retention will be identified by inability to void within 8 hours after catheter removal, associated suprapubic fullness and/or tenderness, and a bladder scan volume greater than 300 mL; or by spontaneous voiding with urinary symptoms and a post-void residual volume greater than 300 mL. Symptoms include suprapubic pain or fullness, bladder pressure, incomplete emptying, or straining. |
From initial post operative urinary catheter removal through hospital discharge, assessed up to 90 days.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Percentage of Participants With Urinary Tract Infection
Časové okno: From post operative day one through hospital discharge, assessed up to 90 days.
|
Urinary tract infection will be identified by clinical signs or symptoms such as suprapubic pain or tenderness, dysuria, hematuria, or urinary frequency, together with a urine culture showing more than 100,000 colony-forming units/mL of bacteria. Urinalysis and urine culture will be obtained only when infection is clinically suspected. |
From post operative day one through hospital discharge, assessed up to 90 days.
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Postoperative Hospital Length of Stay
Časové okno: From post operative day one through hospital discharge, assessed up to 90 days.
|
Number of inpatient hospital days from the day of surgery to the day of discharge. |
From post operative day one through hospital discharge, assessed up to 90 days.
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- HS-25-00655
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Consent does not permit sharing; will revisit
Informace o lécích a zařízeních, studijní dokumenty
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