Benign Prostatic Hypertrophy, Kidney Calculi, Urologic Diseases
Conditions
Brief summary
This study is designed to assess if there is a significant difference in same day discharge rates after Holmium Laser Enucleation of the Prostate (HoLEP). The investigators attempt to perform HoLEP as a same-day discharge (SDD) procedure, but at Northwestern Memorial, the SDD rate is currently approximately 60%. The limiting factor in SDD is hematuria. Tranexamic acid (TXA) is a clot promoting drug that is commonly used by orthopedic, cardiac and obstetric surgeons to prevent bleeding. The primary outcome will be to assess if there is a difference in SDD rates in those who receive TXA vs. those who do not. Secondary outcomes will assess bleeding complications (defined as unplanned ED visit/clinic visit/procedure/admission related to bleeding, clot retention, clot evacuation, need for perioperative transfusion) between participants who receive TXA vs. those do not. The study will also assess differences in perioperative complications associated with TXA including but not limited to: deep venous thrombosis, pulmonary embolism, cerebrovascular events, between the groups. The study will also assess for the duration of postoperative hematuria between groups as well as differences in operative times between the groups. The investigators anticipate that there may be up to a 25% increase in SDD rates in those who receive TXA vs. those who do not.
Detailed description
On the day of the surgery, the treatment assigned to the participant will be determined by chance, like flipping a coin. One arm will undergo the HoLEP procedure while receiving 1g TXA IV intraoperatively. The second arm will undergo the HoLEP procedure without receiving TXA IV intraoperatively. After surgery, participants will receive weekly surveys via text message or email asking them to report any instances of difficulty urinating or blood in the urine. These surveys will continue for 12 weeks. 30 days after surgery, participants will come in for a standard clinical follow up appointment where they will be asked to complete a questionnaire about bleeding complications and symptoms. 12 weeks after surgery, participants will come in for their 12-week follow up and will be assessed for benign prostate hyperplasia (BPH) symptoms and their urine flow rate will be measured.
Interventions
DRUGTranexamic acid
Patients in the intervention arm will receive 1g of intraoperative IV TXA during the HoLEP procedure.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Males 18-89 undergoing HoLEP * Willing to sign the Informed Consent Form * Able to read, understand, and complete patient questionnaires, pain texts, and medication diary
Exclusion criteria
* Allergy or hypersensitivity to TXA, history of acute venous or arterial thrombosis, intrinsic risk for thrombosis or thromboembolism, history of thromboembolic disease, hereditary thrombophilia, use of hormonal agents * Patients having any additional simultaneous procedure other than a HoLEP (cystolitholapaxy allowed). * Anticipated need for perineal urethrostomy at the time of HoLEP * Patient not undergoing catheter removal and voiding trial at Northwestern Memorial Hospital
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Same-day Discharge Rate | Day 0-1 | Number of participants who are discharged on the same day and have same-day catheter removal. |
| Length of Stay | Day 0-1 | Post-operative to discharge home |
| Same Day Discharge | 24 hours | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Bleeding Complications | 12 weeks | Participants who have bleeding complications (defined as unplanned ED visit/clinic/procedure/admission related to bleeding, clot retention, clot evacuation, need for perioperative transfusion). This will be assessed by a weekly survey distributed to participants for 12 weeks. |
| Adverse Events Related to TXA | 12 weeks | Number of participants who have adverse events related to TXA (thrombotic events (DVT, PE, stroke), seizures). |
| Duration of Postoperative Hematuria | 12 weeks | Days participants have postoperative hematuria. This will be assessed by a weekly survey distributed to participants for 12 weeks. |
| Operative Times | Day 0 | Operative times during HoLEP procedure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TXA Intraoperatively Patients will receive intraoperative 1g TXA during the HoLEP procedure.
Tranexamic acid: Patients in the intervention arm will receive 1g of intraoperative IV TXA during the HoLEP procedure. | 55 |
| No TXA Intraoperatively Patients will not receive intraoperative TXA during the HoLEP procedure. | 55 |
| Total | 110 |
Baseline characteristics
| Characteristic | TXA Intraoperatively | No TXA Intraoperatively | Total |
|---|---|---|---|
| Age, Continuous | 69.1 years | 69.7 years | 69.4 years |
| Pre-op Prostate size, continious | 114 cc | 105.5 cc | 109.8 cc |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 55 participants | 55 participants | 110 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 55 Participants | 55 Participants | 110 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 55 |
| other Total, other adverse events | 9 / 55 | 17 / 55 |
| serious Total, serious adverse events | 1 / 55 | 0 / 55 |
Outcome results
Primary
Length of Stay
Post-operative to discharge home
Time frame: Day 0-1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TXA Intraoperatively | Length of Stay | 170 minutes |
| No TXA Intraoperatively | Length of Stay | 187 minutes |
Primary
Same Day Discharge
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TXA Intraoperatively | Same Day Discharge | 51 Participants |
| No TXA Intraoperatively | Same Day Discharge | 49 Participants |
Primary
Same-day Discharge Rate
Number of participants who are discharged on the same day and have same-day catheter removal.
Time frame: Day 0-1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TXA Intraoperatively | Same-day Discharge Rate | 50 Participants |
| No TXA Intraoperatively | Same-day Discharge Rate | 49 Participants |
Secondary
Adverse Events Related to TXA
Number of participants who have adverse events related to TXA (thrombotic events (DVT, PE, stroke), seizures).
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TXA Intraoperatively | Adverse Events Related to TXA | 0 Participants |
| No TXA Intraoperatively | Adverse Events Related to TXA | 0 Participants |
Secondary
Duration of Postoperative Hematuria
Days participants have postoperative hematuria. This will be assessed by a weekly survey distributed to participants for 12 weeks.
Time frame: 12 weeks
Secondary
Number of Participants With Bleeding Complications
Participants who have bleeding complications (defined as unplanned ED visit/clinic/procedure/admission related to bleeding, clot retention, clot evacuation, need for perioperative transfusion). This will be assessed by a weekly survey distributed to participants for 12 weeks.
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TXA Intraoperatively | Number of Participants With Bleeding Complications | 4 Participants |
| No TXA Intraoperatively | Number of Participants With Bleeding Complications | 6 Participants |
Secondary
Operative Times
Operative times during HoLEP procedure.
Time frame: Day 0
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TXA Intraoperatively | Operative Times | 58 minutes |
| No TXA Intraoperatively | Operative Times | 53 minutes |