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OpenTrials
Completed

NCT Number: NCT05314582

Anticoagulant/Antiaggregant Use and Postoperative Bleeding Risk in Patients With Bladder Tumor and Benign Prostatic Hyperplasia

Patients who were using anticoagulant or antiaggregant medications for any reason and underwent transurethral resection of bladder tumor (TUR-BT) or transurethral resection of the prostate (TURP) or open prostatectomy (OP) due to BPH will be compared with those who were not using anticoagulant or antiplatelet medication. The rates of postoperative clot retention, presence of hematuria, reoperation due to hematuria, blood transfusion and re-admissions due to hematuria in the first postoperative month will be compared.

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Key information

Conditions

Hematuria Blood Transfusion Complication Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Immune System Diseases Male Urogenital Diseases Neoplasms Neoplasms by Site Operative Bleeding Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Retention, Urinary Transfusion Reaction Urinary Bladder Diseases Urinary Bladder Neoplasms Urinary Retention Urination Disorders Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Bezmialem Vakif University

Istanbul, 34093, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing complete endoscopic transurethral tumor resection (TUR-BT) for bladder cancer
  • Patients undergoing TURP due to benign prostatic hyperplasia
  • Patients undergoing open prostatectomy due to benign prostatic hyperplasia

Exclusion criteria

  • Patients who underwent incomplete transurethral tumor resection for bladder cancer
  • Patient who underwent TUR biopsy for restaging with no obvious macroscopic tumoral lesion
  • Patients who underwent cystectomy for bladder cancer

Treatment and study plan

Primary outcomes

  1. Episode of clot retention

    Time frame: Immediately after the surgery up to 1 month

    Presence of clot retention due to hematuria after the operation which requires manuel irrigation

  2. Requirement of blood transfusion

    Time frame: Immediately after the surgery up to 1 month

    Gross hematuria requiring blood transfusion

  3. Re-operation rates

    Time frame: Immediately after the surgery up to 1 month

    Re-operation requirement for hematuria

  4. Duration of hospitalization

    Time frame: Immediately after the surgery up to discharge

    Duration of hospitalization

  5. Rate of re-admission

    Time frame: From discharge up to one month

    Rate of re-admission due to hematuria

Secondary outcomes

  1. Postoperative hematocrit/hemoglobin levels

    Time frame: Immediately after the surgery up to discharge

    Change in the Postoperative hematocrit/hemoglobin levels compared to the preoperative values.

  2. Amount of irrigation volume

    Time frame: Immediately after the surgery up to discharge

    Amount of postoperative continuous bladder irrigation volume

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

Investigation of the Effects of Anticoagulant/Antiaggregant Use on Postoperative Bleeding Risk in Patients Operated for Bladder Tumor and Benign Prostatic Hyperplasia

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Apr 6, 2022
Registry last updated
Jul 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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