Status:
NOT_YET_RECRUITING
Robotic Prostatectomy Artificial Intelligence Low Pressure Pain (RALP) Trial
Lead Sponsor:
East and North Hertfordshire NHS Trust
Conditions:
Prostate Cancer (Adenocarcinoma)
Prostate Cancer (Post Prostatectomy)
Eligibility:
MALE
18-75 years
Phase:
NA
Brief Summary
The 'Robotic Prostatectomy Artificial Intelligence Low Pressure Pain Study Trial' aims to assess the feasibility of being able to review operative outcomes such as pain when comparing two commonly use...
Detailed Description
In this trial, 40 patients undergoing robotic prostatectomies will be randomised to have either the AIRSEAL® Insufflation System (AIS) or the Stryker PneumoClear Insufflator devices used to maintain p...
Eligibility Criteria
Inclusion
- Patient indicated for non-emergent robotic Prostatectomy surgery
- Patients (or appropriate legal representatives) able to provide written informed consent to participate in the study
- Males, aged 18 to 75 years
- Have no significant psychopathology that could limit the subject's ability to understand the procedure, comply with medical, surgical, and/or behavioural recommendations and office visits
- Are American Society of Anaesthesiologists (ASA) Class I, II, or III);
Exclusion
- Patient participation in a different investigational clinical study within 90 days before screening and for the duration of this trial (unless previously approved by the investigator and Sponsor);
- Patients requiring any surgical procedure in addition to Prostatectomy and or / Pelvic Lymph node dissection
- Previous pelvic surgery or previous malabsobtion or restrictive procedures performed for the treatment of obesity
- Inability to provide informed consent
- Unable or unwilling to attend follow-up visits and examinations
- Uncontrolled hypertension (=/\>Systolic: 180 mmHg/Diastolic: 120 mmHg) and/or diabetes mellitus (Blood sugar level: \>200 mg/dL)
- Patients who fall into American Society of Anesthesiologists (ASA) Class ≥ IV
- History of chronic alcohol or drug abuse within 2 years of the screening visit
- Chronic renal failure or on dialysis
- Significant complicating medical history or immunocompromised
- History or presence of pre-existing autoimmune connective tissue disease, e.g., systemic lupus erythematosus or scleroderma
- Immunocompromised such as that resulting from chronic oral steroid use, chemotherapeutic agents, or immune deficiency disorders;
- Any medical condition which precludes compliance with the study
- Subjects with any other clinically significant unstable medical disorder, life threatening disease, or conditions that, in the opinion of the investigator, may jeopardize the subject's well-being and/or the soundness of this clinical study or which would contra-indicate a surgical procedure.
- Previous or current history of being on regular analgesia / pain killers
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06915909
Start Date
April 1 2025
End Date
July 1 2025
Last Update
April 8 2025
Active Locations (1)
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1
Lister hospital
Stevenage, Hertfordshire, United Kingdom, SG1 4AB