Trial Outcomes & Findings for Use of Hypothermia During Robotic Prostatectomy (NCT NCT00915031)

Last Updated: 2019-03-27

Results Overview

The primary aim is confirmation of the feasibility and safety using an improved, more efficient and less labor intensive cooling balloon in patients undergoing hypothermic nerve-sparing RLP. Continence is defined as no protective urinary pad use as reported by the patient in response to the very first question on page 1 of the sample questionnaire.

Recruitment status

COMPLETED

Study phase

Target enrollment

738 participants

Primary outcome timeframe

During and 6 hours post surgery

Results posted on

2019-03-27

Participant Flow

Eligible patients will be given written and verbal explanation of the study objectives; procedures; potential risks; measures taken to protect confidentiality; any associated costs; alternatives; new findings; and investigator disclosures. Patients will be given time to ask questions.

Participant milestones

Participant milestones
Measure	Hypothermia Only OR Use of Hypothermia Cooling device only in the operating room UroCool: Hypothermia Endorectal Device	Hypothermia in OR + Recovery Use of hypothermia cooling device in the operating room and up to five hours after surgery. UroCool: Hypothermia Endorectal Device
Overall Study STARTED	714	24
Overall Study COMPLETED	714	24
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of Hypothermia During Robotic Prostatectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hypothermia Only OR n=714 Participants Use of Hypothermia Cooling device only in the operating room UroCool: Hypothermia Endorectal Device	Hypothermia in OR + Recovery n=24 Participants Use of hypothermia cooling device in the operating room and up to five hours after surgery. UroCool: Hypothermia Endorectal Device	Total n=738 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	246 Participants n=5 Participants	15 Participants n=7 Participants	261 Participants n=5 Participants
Age, Categorical >=65 years	468 Participants n=5 Participants	9 Participants n=7 Participants	477 Participants n=5 Participants
Age, Continuous	62.677 Years STANDARD_DEVIATION 7.2 • n=5 Participants	62.677 Years STANDARD_DEVIATION 7.2 • n=7 Participants	62.677 Years STANDARD_DEVIATION 7.2 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	714 Participants n=5 Participants	24 Participants n=7 Participants	738 Participants n=5 Participants
Region of Enrollment United States	714 participants n=5 Participants	24 participants n=7 Participants	738 participants n=5 Participants

PRIMARY outcome

Timeframe: During and 6 hours post surgery

Outcome measures

Outcome measures
Measure	Hypothermia Only OR n=714 Participants Use of Hypothermia Cooling device only in the operating room UroCool: Hypothermia Endorectal Device	Hypothermia in OR + Recovery n=24 Participants Use of hypothermia cooling device in the operating room and up to five hours after surgery. UroCool: Hypothermia Endorectal Device
Feasibility and Safety Using an Improved, More Efficient and Less Labor Intensive Cooling Balloon in Patients Undergoing Hypothermic Nerve-sparing RLP in Participants Determined by Return to Continence	714 Participants	24 Participants

Adverse Events

General Adverse Events

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	General Adverse Events n=738 participants at risk Both arms: An adverse event (AE) is any undesirable experience (sign, symptom, significant laboratory abnormality, illness, or other medical event) occurring to a patient that appears or worsens during a clinical study, regardless of etiology. * Mild - Awareness of signs or symptoms that are easily tolerated. Signs and symptoms are transient and only of minor irritant type and cause no loss of time from normal activities; symptoms do not require medication or a medical evaluation. * Moderate - Discomfort severe enough to cause interference with usual activities. Symptoms may require treatment but not extended hospitalization or intensive care for the patient. * Severe - Incapacitating with inability to do work or usual activities. Signs and symptoms may be of systemic nature or require medical evaluation and/or treatment that requires prolonged hospital stay
Gastrointestinal disorders AE1	0.14% 1/738 • Number of events 1 • 5 years Adverse events were not broken by arm as both groups used the same device and underwent the same procedure leading to a large cohort of patients who underwent cooling. Adverse event reporting was irrespective of arm and cannot be separated. Adverse events were also assessed irrespective of terms.
Product Issues AE2	0.14% 1/738 • Number of events 1 • 5 years Adverse events were not broken by arm as both groups used the same device and underwent the same procedure leading to a large cohort of patients who underwent cooling. Adverse event reporting was irrespective of arm and cannot be separated. Adverse events were also assessed irrespective of terms.

Additional Information

Linda Huynh

University of California, Irvine

Phone: 7144567354

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place