Robotic Prostatectomy Pain Reduction with Two Insufflation Devices

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This feasibility study compares the AIRSEAL Insufflation System (AIS) with the Stryker PneumoClear device during robotic prostatectomy to see if they influence intra- and post-operative pain. 100 eligible patients will be randomized to receive one of the two insufflation systems, with data collected on pain and other surgical outcomes. The study aims to inform the design of a larger, multi-center trial by assessing recruitment, study conduct, data collection, adverse events, and potential effect size. Outcomes will guide future investigations into pain management following prostate cancer surgery. The trial is conducted at Lister Hospital in Stevenage, led by East and North Hertfordshire NHS Trust.

Why it matters

Who can join: the full rules

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

Where it's running

• Lister hospital
  Stevenage, Hertfordshire, United Kingdom Recruiting

Study contacts

• Study coordinator: Nikhil Vasdev
• Email: nikhil.vasdev@nhs.net
• Phone: +441438284042

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.