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

NCT05285189 | Unknown

• 1 other identifier: 2018/1378
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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. .

Conditions

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

Keywords

Blood gas analysis; TUR-P; Irrigation Fluid; Hyperchloremia

Outcome Measures

Primary Outcomes (1)

• Serum Chlorid level

  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.

  Up to 4 hours

Secondary Outcomes (11)

• Serum anion gap level

  Up to 4 hours

• Serum lactate level

  Up to 4 hours

• Presence&absence of capsule perforation during the operation

  Up to 4 hours

• Amount of prostate tissue resected during the operation

  Up to 4 hours

• Amount of used normal saline for irrigation during the operation

  Up to 4 hours

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Having benign prostate hyperplasia
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Male gender who being prostate hyperplasia * Having had a TUR-P operation * Using of bipolar technic * American Society of Anesthesiology (ASA) grade I-III * Receiving patients consent

You may qualify if:

• Male gender
• Having had a TUR-P operation
• Using of bipolar technic
• American Society of Anesthesiology (ASA) grade I-III
• Receiving patients consent

You may not qualify if:

• Failure to record preoperative and postoperative blood gas data
• Patient refusal

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University

Istanbul, 34093, Turkey (Türkiye)

RECRUITING

Related Publications (2)

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

  PMID: 25768968 RESULT

• 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.

  PMID: 26999998 RESULT

Study Officials

• Meltem Savran Karadeniz, Assoc.Prof.

  Istanbul University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabiha Başarı, MD

CONTACT

+905446616686; sabihabasari0@gmail.com

Meltem Savran Karadeniz, Assoc.Prof.

CONTACT

+905334845563; mskaradeniz@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 17, 2022
• Study Start: January 1, 2019
• Primary Completion: July 29, 2022
• Study Completion: July 31, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

TU (1)