臨床研究等提出・公開システム

Investigation of usefulness of bicarbonate Ringer's solution in during transurethral resection of prostate (TURP) (TURP using bicarbonate Ringer's solution)

Investigation of usefulness of bicarbonate Ringer's solution in during transurethral resection of the prostate (TURP) (TURP using bicarbonate Ringer's solution)

22

This study included patients with clinically benign prostatic hyperplasia (BPH). All genders were male. Average age was 67.2 years (59-75).

This clinical study is intended to compare the irrigation fluid used in transurethral resection of the prostate (TUR-P) between two groups in patients with benign prostatic hyperplasia (BPH). Therefore, when the patients with BPH visited the hospital, we considered whether they could be included in this study at the Kyoto Prefectural University of Medicine and the associated hospital. Number of registered cases by year were 4 cases in 2014, 2 cases in 2015, 6 cases in 2016, 2 cases in 2017, 2 cases in 2018, 2 cases in 2019, 3 cases in 2020, 1 case in 2021 and 0 case in 2022.

There were no grade 3 or higher adverse events in this study.

Two-group analysis was attempted in 22 patients, but no significant difference was obtained for the primary and secondary endpoints.

Since the number of surgeries for benign diseases other than cancer was limited at this university hospital, this research was promoted with the cooperation of affiliated hospitals. Furthermore, as the COVID-19 epidemic and endoscopic surgical procedures for benign prostatic hyperplasia have shifted from transurethral resection to transurethral vaporization. For these reasons, enrollment of cases fell short of the original plan.

Sept. 01, 2023

Feb. 10, 2021

https://pubmed.ncbi.nlm.nih.gov/33681527/

No

none

https://jrct.mhlw.go.jp/latest-detail/jRCTs051180234

Hongo Fumiya

University Hospital, Kyoto Prefectural University of Medicine

465 Kajii-cho Kamigyo-ku Kyoto 602-8566, Japan

fhongo@koto.kpu-m.ac.jp

Hongo Fumiya

University Hospital, Kyoto Prefectural University of Medicine

465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, JAPAN.

+81-75-251-5595

fhongo@koto.kpu-m.ac.jp

Complete

June. 01, 2014

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

prevention purpose

Among patients who are indicated for TURP for benign prostatic hyperplasia, patients with oral and written informed consent for this study are included.

1) Cases of bladder cancer and/or prostate cancer
2) Cases with severe disorders such as cardiac function, kidney function, liver function, hematopoietic function
3) Other cases that the doctor considers inappropriate.

Male

Prostatic hyperplasia

We will prospectively compare the group using bicarbonate Ringer's solution as a perfusion solution and the group using physiological saline for the onset of acidosis dilution during transurethral resection of prostate.

prostate hyperplasia

C12.294.565.500

Safety and efficacy during perfusion of bicarbonate Ringer's solution (presence or absence of dilutory acidosis)

Blood pH, bicarbonate ion concentration, Anion Gap, base excess, chloride

+81-75-251-5337

Mar. 06, 2019

none