Robotic Prostatectomy Artificial Intelligence Low Pressure Pain (RALP) Trial

Launched by EAST AND NORTH HERTFORDSHIRE NHS TRUST · Mar 31, 2025

Keywords

ClinConnect Summary

The Robotic Prostatectomy Artificial Intelligence Low Pressure Pain Trial is a study designed to see how different surgical devices affect pain levels after prostate cancer surgery. During a robotic prostatectomy, surgeons use a device to inflate the abdomen with gas, which helps them see the prostate better. However, using higher pressure can lead to more pain after the surgery. This trial will compare two commonly used devices to find out which one causes less pain for patients undergoing this procedure.

To participate in this study, men aged 18 to 75 who are scheduled for a non-emergency robotic prostatectomy at the Lister Hospital in Stevenage may be eligible. Participants will be randomly assigned to use either the Conventional Insufflator System or the AIRSEAL® Insufflation System during their surgery. Researchers will collect information about pain, medication use, and recovery over 30 days after the surgery. This information will help improve future studies and may lead to better pain management for patients having prostate surgery.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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