TEMPOUR: A Randomized Controlled Trial Assessing Perioperative Use of an Alpha-1 Blocker to Reduce Postoperative Urinary Retention After Transanal Endoscopic Microsurgery Procedures
Bibliographic record
Abstract
BACKGROUND: Transanal endoscopic microsurgery is a treatment option for a wide range of rectal lesions. Postoperative urinary retention is a frequently associated complication. Some studies have suggested that the use of alpha-1 blockers may reduce the risk of postoperative urinary retention after hernia and colorectal surgery, but evidence is lacking. OBJECTIVE: This trial aims to evaluate whether prophylactic use of an alpha-1 blocker reduces the rate of postoperative urinary retention after transanal endoscopic microsurgery. DESIGN: Double-blinded, placebo-controlled trial. SETTINGS: Single high-volume Canadian colorectal center. PATIENTS: Adult male patients awaiting transanal endoscopic microsurgery and not taking alpha-1 blockers were included. INTERVENTION: Patients were allocated to either tamsulosin or placebo from 5 days before surgery to 2 days postoperatively. MAIN OUTCOMES MEASURES: The primary outcome was the incidence of postoperative urinary retention. Secondary outcomes were urinary retention-related hospitalization, time to removal of a bladder catheter, International Prostate Symptom Score (before and after treatment), and adverse events. RESULTS: 158 patients were randomly assigned between October 2017 and July 2022. There was no significant difference in postoperative urinary retention between groups (23% vs 14%; p = 0.16), respectively, in the tamsolusin and placebo groups. Time to removal of bladder catheter was not statistically different between groups (4.8 vs 8.6 days, p = 0.26). No failure of same-day discharge nor readmissions related to urinary retention occurred. International Prostate Symptom Scores were not significantly different at the time of surgery (3.8 vs 5.4; p = 0.11), and reported adverse events did not differ between groups. LIMITATIONS: We cannot exclude a potential type II error. CONCLUSIONS: Prophylactic use of an alpha-1 blocker for patients undergoing transanal endoscopic microsurgery was not associated with a reduction in postoperative urinary retention. See Video Abstract. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03314025. TEMPOUR UN ENSAYO CONTROLADO ALEATORIZADO QUE EVALA EL USO PERIOPERATORIO DE UN BLOQUEADOR ALFA PARA REDUCIR LA RETENCIN URINARIA POSOPERATORIA DESPUS DE MICROCIRUGA ENDOSCPICA TRANSANAL: ANTECEDENTES:La microcirugía endoscópica transanal es una opción de tratamiento para una amplia gama de lesiones rectales. La retención urinaria posoperatoria es una complicación frecuentemente asociada. Algunos estudios han sugerido que el uso de bloqueadores alfa-1 puede reducir el riesgo de retención urinaria posoperatoria después de cirugía colorrectal o de hernia, pero falta evidencia al respecto.OBJETIVO:Este ensayo tiene como objetivo evaluar si el uso profiláctico de un bloqueador alfa-1 reduce la tasa de retención urinaria posoperatoria después de microcirugía endoscópica transanal.DISEÑO:Ensayo doble ciego, controlado con placebo.ESCENARIO:Un solo centro colorrectal canadiense de alto volumen.PACIENTES:Se incluyeron pacientes adultos de sexo masculino que esperaban una microcirugía endoscópica transanal y que no tomaban bloqueadores alfa-1.INTERVENCIÓN:Los pacientes fueron asignados a tamsulosina o placebo desde 5 días antes de la cirugía hasta 2 días después de la operación.PRINCIPALES MEDIDAS DE RESULTADOS:El resultado primario fue la incidencia de retención urinaria posoperatoria. Los resultados secundarios fueron la hospitalización relacionada con la retención urinaria, el tiempo hasta la extracción de la sonda vesical y la Escala Internacional de Síntomas de Próstata, antes y después del tratamiento, y los eventos adversos.RESULTADOS:Se aleatorizaron 158 pacientes entre octubre de 2017 y julio de 2022. No hubo diferencias significativas en la retención urinaria posoperatoria entre los grupos (23% frente a 14%; p = 0.16) respectivamente en los grupos de tamsolusina y placebo. El tiempo hasta la extracción de la sonda vesical no fue estadísticamente diferente entre los grupos (4.8 frente a 8.6 días, p = 0.26). No se produjo ningún fracaso del alta el mismo día ni reingresos relacionados con la retención urinaria. Las calificaciones de la Escala Internacional de Síntomas de Próstata no fueron significativamente diferentes en el momento de la cirugía (3.8 frente a 5.4; p = 0.11) y los eventos adversos notificados no difirieron entre los grupos.LIMITACIONES:No podemos excluir un posible error de tipo II.CONCLUSIÓN:El uso profiláctico de un bloqueador alfa-1 en pacientes sometidos a microcirugía endoscópica transanal no se asoció con una reducción de la retención urinaria posoperatoria. (Traducción-Dr. Jorge Silva Velazco )REGISTRO DEL ENSAYO:ClinicalTrials.gov Identificador: NCT03314025.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".