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

NCT ID: NCT05285189

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2022-07-31

Brief Summary

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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

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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.

Conditions

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Hyperchloremic Acidosis Transurethral Resection of Prostate Normal Anion Gap Metabolic Acidosis Anesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Meltem Savran Karadeniz

Assoc.Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Meltem Savran Karadeniz, Assoc.Prof.

Role: PRINCIPAL_INVESTIGATOR

Istanbul University

Locations

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Istanbul University

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Sabiha Başarı, MD

Role: CONTACT

+905446616686

Meltem Savran Karadeniz, Assoc.Prof.

Role: CONTACT

+905334845563

Facility Contacts

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Meltem Savran Karadeniz, Assoc.Prof.

Role: primary

References

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Barker ME. 0.9% saline induced hyperchloremic acidosis. J Trauma Nurs. 2015 Mar-Apr;22(2):111-6. doi: 10.1097/JTN.0000000000000115.

Reference Type RESULT
PMID: 25768968 (View on PubMed)

Dombre V, De Seigneux S, Schiffer E. [Sodium chloride 0.9%: nephrotoxic crystalloid?]. Rev Med Suisse. 2016 Feb 3;12(504):270-2, 274. French.

Reference Type RESULT
PMID: 26999998 (View on PubMed)

Other Identifiers

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2018/1378

Identifier Type: -

Identifier Source: org_study_id

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