Effects of Isotonic Saline As Irrigation Fluid In Transurethral Resection of Prostate (TUR-P) Operations
- Conditions
- Hyperchloremic AcidosisTransurethral Resection of ProstateNormal Anion Gap Metabolic AcidosisAnesthesia
- Registration Number
- NCT05285189
- Lead Sponsor
- Istanbul University
- Brief Summary
Benign hypertrophy of the prostate (BPH) is a disease seen in 20% of men over the age of 50 and in 40% of those over the age of 70. The gold standard in the treatment of BPH is transurethral resection of the prostate using high-frequency diathermy. Today, this process is done with the bipolar technique, in which isotonic saline (isotonic sodium chloride %0.9) is used as the irrigation fluid. This irrigation fluid, which is used after long operation and deep tissue resection, can enter the systemic circulation through the opened venous sinuses.
It has been shown in clinical studies that postoperative acute hyperchloremia (serum Cl level \> 110 mmol/L) develops after the use of intravenous normal saline solution in large amounts in the perioperative period.
Our aim is to detect hyperchloremia and associated metabolic acidosis without anion gap in the follow-up of these patients. Our primary hypothesis in this study is that hyperchloremic metabolic acidosis will develop due to the high amount of normal saline used in TUR-P.
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- Detailed Description
Benign hypertrophy of the prostate (BPH) is a disease seen in 20% of men over the age of 50 and in 40% of those over the age of 70. The gold standard in the treatment of BPH is transurethral resection of the prostate using high-frequency diathermy. Today, this process is done with the bipolar technique, in which normal saline (isotonic sodium chloride %0.9) is used as the irrigation fluid. In bipolar TUR-P, resection is performed using 25000 - 30000 ml normal saline for irrigation. This irrigation fluid, which is used after long operation and deep tissue resection, can enter the systemic circulation through the opened venous sinuses.
It has been shown in clinical studies that postoperative acute hyperchloremia (serum Cl level \> 110 mmol/L) develops after the use of intravenous normal saline solution in large amounts in the perioperative period. McCluskey et al. found that 30-day mortality, prolonged hospital stay, and postoperative renal dysfunction developed in patients who received perioperative intravenous normal saline and subsequently developed acute hyperchloremia. Megan E. et al. Scheingraber et al. reported that the use of normal saline increases the risk of acidosis and kidney damage, also compared Ringer's lactate and normal saline infusion in patients who underwent gynecological surgery and showed that hyperchloremic metabolic acidosis developed in normal saline group. Excessive and rapid administration of normal saline solution by parenteral route causes hyperchloremic metabolic acidosis, which adversely affects the organism. According to recent studies, the development of hyperchloremic metabolic acidosis increases the cost and mortality, prolongs the hospitalization period, and causes renal dysfunction.
Our aim is to detect hyperchloremia and associated metabolic acidosis without anion gap in the follow-up of these patients. Our primary hypothesis in this study is that hyperchloremic metabolic acidosis will develop due to the high amount of normal saline used in TUR-P.
The investigators expect that an increase in the amount of fluid, prolongation of the operation time, and capsule perforation will increase hyperchloremia and deepen metabolic acidosis. If it causes hyperchloremic metabolic acidosis, the contribution of the amount of irrigation fluid or the duration of the operation can be determined, and the maximum amount of fluid that does not adversely affect the organism and the duration of the operation can be predicted.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 75
- Male gender
- Having had a TUR-P operation
- Using of bipolar technic
- American Society of Anesthesiology (ASA) grade I-III
- Receiving patients consent
- Failure to record preoperative and postoperative blood gas data
- Patient refusal
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum Chlorid level Up to 4 hours Chlorid level is evaluated with blood gas analysis 3 times in total, at the beginning of the operation, at the 40th minute of the operation and 1st hour of arrival in post-anesthesia care unit.
- Secondary Outcome Measures
Name Time Method Duration of operation Up to 4 hours The effect of operation time on hyperchloremia.
Serum anion gap level Up to 4 hours It is evaluated with blood gas analysis 3 times in total, at the beginning of the operation, at the 40th minute of the operation and 1st hour of arrival in post-anesthesia care unit.
Serum lactate level Up to 4 hours It is evaluated with blood gas analysis 3 times in total, at the beginning of the operation, at the 40th minute of the operation and 1st hour of arrival in post-anesthesia care unit.
Incidence of postoperative acute kidney injury Up to 48 hours AKI was diagnosed by an increase in serum creatinine concentration \>50% from a baseline creatinine concentration measured within 48 hours prior to enrollment
Incidence of mortality rate Up to 6 months Mortality of the patients was screened retrospectively at 6 months postoperatively.
Length of hospital stay Up to 1 week Length of patients hospital stay was screened retrospectively at 1 week postoperatively.
Number of participants with urinary bladder hematoma Up to 1 week Urinary system ultrasound in patients with severe hematuria
Presence&absence of capsule perforation during the operation Up to 4 hours Effect of capsule perforation on hyperchloremia
Amount of prostate tissue resected during the operation Up to 4 hours The effect of the amount of prostate tissue resected during the operation on hyperchloremia.
Amount of used normal saline for irrigation during the operation Up to 4 hours The effect of the amount of used normal saline for irrigation during the operation on hyperchloremia.
Number of participants with urethral stricture Up to 6 months Diagnosis will be made by urethroscopy in patients with voiding complaints.
Trial Locations
- Locations (1)
Istanbul University
🇹🇷Istanbul, Turkey