[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586479":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":27,"locations":33,"responsibleParty":51,"collaborators":18,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":18,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":18,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":77,"overallStatus":86,"whyStopped":18,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"East and North Hertfordshire NHS Trust","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Stryker PneumoClear insufflator","ACTIVE_COMPARATOR","Measuring patient's pain during and after a robotic prostatectomy using the Stryker PneumoClear insufflator. 20 patients will be randomised and assigned to this arm of the trial. Post-op pain outcomes will be compared to the control arm (standard of care), the AirSeal Insufflation System.",[13],"Device: surgery",{"label":15,"type":16,"description":17,"interventionNames":18},"AirSeal® Insufflation System","NO_INTERVENTION","Measuring patient's pain during and after a robotic prostatectomy using the AirSeal® Insufflation System. 20 patients will be randomised and assigned to this arm of the trial. This device is the standard of care at the Lister hospital, Stevenage, UK.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","surgery","40 patients randomised to two arms will undergo robotic prostatectomies using either the control AirSeal® Insufflation System (AIS) or the intervention Stryker PneumoClear Insufflator. Intra-operative and post-operative pain will be compared between the two arms of the trial.",[9],[26],"Robotic assisted laparoscopic prostatectomy",[28],{"name":29,"role":30,"phone":31,"phoneExt":18,"email":32},"Nikhil Vasdev","CONTACT","07786657541","nikhil.vasdev@nhs.net",[34],{"facility":35,"status":18,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Lister hospital","Stevenage","Hertfordshire","SG1 4AB","United Kingdom","UK",{"type":42,"coordinates":43},"Point",[44,45],-0.20256,51.90224,{"lat":45,"lon":44},[48,49],{"name":29,"role":30,"phone":31,"phoneExt":18,"email":32},{"name":29,"role":50,"phone":18,"phoneExt":18,"email":18},"PRINCIPAL_INVESTIGATOR",{"type":52,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100586479","robotic-prostatectomy-artificial-intelligence-low-pressure-pain-ralp-trial-100586479",false,"NCT06915909","Robotic Prostatectomy Artificial Intelligence Low Pressure Pain (RALP) Trial","Robotic Prostatectomy Artificial Intelligence Low Pressure Pain Study Trial - \"The Monitoring of Patients Outcomes Intraoperatively and Perioperatively Using the Airseal and Stryker Insufflator Undergoing Robotic Assisted Laparoscopic Prostatectomy at a Pressure and Stability of Pneumoperitoneum of 8 mmHg\"","Inclusion Criteria:\n\n* Patient indicated for non-emergent robotic Prostatectomy surgery\n* Patients (or appropriate legal representatives) able to provide written informed consent to participate in the study\n* Males, aged 18 to 75 years\n* Have no significant psychopathology that could limit the subject's ability to understand the procedure, comply with medical, surgical, and\u002For behavioural recommendations and office visits\n* Are American Society of Anaesthesiologists (ASA) Class I, II, or III);\n\nExclusion Criteria:\n\n* 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);\n* Patients requiring any surgical procedure in addition to Prostatectomy and or \u002F Pelvic Lymph node dissection\n* Previous pelvic surgery or previous malabsobtion or restrictive procedures performed for the treatment of obesity\n* Inability to provide informed consent\n* Unable or unwilling to attend follow-up visits and examinations\n* Uncontrolled hypertension (=\u002F\\>Systolic: 180 mmHg\u002FDiastolic: 120 mmHg) and\u002For diabetes mellitus (Blood sugar level: \\>200 mg\u002FdL)\n* Patients who fall into American Society of Anesthesiologists (ASA) Class ≥ IV\n* History of chronic alcohol or drug abuse within 2 years of the screening visit\n* Chronic renal failure or on dialysis\n* Significant complicating medical history or immunocompromised\n* History or presence of pre-existing autoimmune connective tissue disease, e.g., systemic lupus erythematosus or scleroderma\n* Immunocompromised such as that resulting from chronic oral steroid use, chemotherapeutic agents, or immune deficiency disorders;\n* Any medical condition which precludes compliance with the study\n* 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\u002For the soundness of this clinical study or which would contra-indicate a surgical procedure.\n* Previous or current history of being on regular analgesia \u002F pain killers","MALE","18 Years","75 Years",{"count":64,"type":65},40,"ESTIMATED","INTERVENTIONAL",[68],"NA","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 used surgical devices for the removal of prostate cancers. The data collected will inform methodologies for future, larger, multi-center trials investigating pain in patients undergoing prostate cancer surgery.\n\nA robotic prostatectomy is a commonly performed surgery used to treat prostate cancer by removing the prostate gland. In order to perform the procedure, the surgeon must 'inflate' (technical term pneumoperitoneum) the patients abdomen with carbon dioxide gas using a device called an insufflator. Adequate 'inflation' of the abdomen ensures the surgeon can clearly visualise the prostate. Unfortunately, higher pressures of abdominal 'inflation' are a large contributor to intra and post-operative pain in patients having prostatectomies. The type of insufflator device used to maintain inflation pressures in the abdomen are thought to be a variable contributing to differing levels of intra and post-operative pain. Therefore, the purpose of this trial is to compare intra and post-operative pain when using two different insufflator devices when performing robotic prostatectomies. Both insufflators are already commonly used across multiple NHS Trusts.\n\n40 patients awaiting a robotic prostatectomy at the urology department at the Lister hospital, Stevenage, will be randomised to use either the Conventional Insufflator System (CIS) {Stryker PneumoClear Insufflator} or the AIRSEAL® Insufflation System (AIS) to 'inflate' their abdomens during their prostatectomies. Data relating to various intra and post-operative outcomes will be collected in the 30 days following the patient's operation. Outcomes include levels of intra and post-operative pain, medication use, procedure time, recovery room time, length of hospital stay, post operative nausea and vomiting and adverse events. This data can be analysed to identify trends in differences in outcomes between the AIS and CIS insufflators.",[71,72,73,74,75,76],"Prostate Cancer (Adenocarcinoma)","Prostate Cancer (Post Prostatectomy)","Prostate Cancer Surgery","Prostate Cancers","Prostate Neoplasm","Prostatectomy",[78,79,80,81,82,9,83,84,85],"prostate cancer","prostatectomy","robotic prostatectomy","post-operative pain","pain","AirSeal Insufflation System","intra-operative pain","Medasense","NOT_YET_RECRUITING","2025-03-31",{"date":89,"type":90},"2025-04-08","ACTUAL",{"date":92,"type":65},"2025-04-01",{"date":94,"type":65},"2025-07-01",{"name":5,"class":6},1]