Effects of Isotonic Saline As Irrigation Fluid In Transurethral Resection of Prostate (TUR-P) Operations

Sponsor
Istanbul University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05285189
Collaborator
(none)
75
1
42.9
1.7

Study Details

Study Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
75 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Effects of Isotonic Saline as Irrigation Fluid on Serum Electrolytes and Blood Gases in Bipolar Transurethral Resection of Prostate (TUR-P) : A Prospective Observational Study
Actual Study Start Date :
Jan 1, 2019
Anticipated Primary Completion Date :
Jul 29, 2022
Anticipated Study Completion Date :
Jul 31, 2022

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. Presence&absence of capsule perforation during the operation [Up to 4 hours]

    Effect of capsule perforation on hyperchloremia

  4. 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.

  5. 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.

  6. Duration of operation [Up to 4 hours]

    The effect of operation time on hyperchloremia.

  7. 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

  8. Incidence of mortality rate [Up to 6 months]

    Mortality of the patients was screened retrospectively at 6 months postoperatively.

  9. Length of hospital stay [Up to 1 week]

    Length of patients hospital stay was screened retrospectively at 1 week postoperatively.

  10. Number of participants with urethral stricture [Up to 6 months]

    Diagnosis will be made by urethroscopy in patients with voiding complaints.

  11. Number of participants with urinary bladder hematoma [Up to 1 week]

    Urinary system ultrasound in patients with severe hematuria

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Male gender

  • Having had a TUR-P operation

  • Using of bipolar technic

  • American Society of Anesthesiology (ASA) grade I-III

  • Receiving patients consent

Exclusion Criteria:
  • Failure to record preoperative and postoperative blood gas data

  • Patient refusal

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul University Istanbul Turkey 34093

Sponsors and Collaborators

  • Istanbul University

Investigators

  • Principal Investigator: Meltem Savran Karadeniz, Assoc.Prof., Istanbul University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Meltem Savran Karadeniz, Assoc.Prof., Istanbul University
ClinicalTrials.gov Identifier:
NCT05285189
Other Study ID Numbers:
  • 2018/1378
First Posted:
Mar 17, 2022
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Meltem Savran Karadeniz, Assoc.Prof., Istanbul University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2022