Robotic Prostatectomy Artificial Intelligence Low Pressure Pain (RALP) Trial

NCT06915909 | Not Yet Recruiting

• 2 other identifiers: RD2024-75346481
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 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. A 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. 40 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.

Conditions

Prostate Cancer (Adenocarcinoma); Prostate Cancer (Post Prostatectomy); Prostate Cancer Surgery; Prostate Cancers; Prostate Neoplasm; Prostatectomy

Keywords

prostate cancer; prostatectomy; robotic prostatectomy; post-operative pain; pain; Stryker PneumoClear insufflator; AirSeal Insufflation System; intra-operative pain; Medasense

Outcome Measures

Primary Outcomes (26)

• Recruitment rates

  Through study completion estimated to be 6-12 months

• Evaluate treatment-based adverse events, serious adverse events, anticipated adverse device effects, unanticipated adverse device effects and all device deficiencies and use errors, regardless of relationship to an adverse event.

  Through study completion estimated to be 6-12 months

• Pre-op vitals

  Bloods pressure, heart rate, oxygen saturations, respiration rate, temperature

  Baseline/day 1

• Pre-op BMI (height and weight)

  kg/m\^2

  Baseline/day 1

• Pre-op labs

  Pre-op FBC, U\&E, CRP and PSA bloods

  Baseline/day 1

• Insufflation Pressure

  Intraoperative insufflation pressure (mmHg)

  Perioperative

• Estimated blood loss

  Estimated intra-operative blood loss (ml)

  Perioperative

• Blood transfusion

  Intra-operative blood transfusions (number of units of blood e.g 0, 1, 2, 3 etc...)

  Perioperative

• Procedure time (initial incision to closure)

  Number of minutes from incision to closure

  Perioperative

• Surgeon-determined need to increase IAP beyond "study pressure"

  Need to increase insufflation pressure intra-operatively (mmHg)

  Perioperative

• Administration of transversus abdominis plane block

  Was a transversus abdominis plane block administered (yes or no)

  Perioperative

• Anesthetic/pain medication administration

  Intra-operative administration of analgesia (morphine milligram equivalent units)

  Perioperative

• MedaSense PMD-200 monitor for pain documentation

  Intra-operative pain score (NOL score 0-100)

  Perioperative

• Intraoperative Peak Airway Pressure every 15 minutes

  Intra-operative PAP (cmH2O)

  Perioperative

• Intraoperative End Tidal Carbon Dioxide (ETCO2) every 15 minutes

  Intra-operative ETCO2 (mmHg)

  Perioperative

• Time in recovery room

  Number of minutes spent in post-op recovery

  Perioperative

• Post-op pain incidence and severity

  Pain measured using visual analogue scale, numerical rating scale and pain incidence and interference surveys. Pain surveys done at 1, 3, 6, 12, 18, 24 hours and day 7 and day 30 post-operation.

  Day 1-30 post-op/post-intervention

• Post-op analgesia usage

  Post-op analgesia usage on discharge (morphine milligram equivalent units)

  Day 1-30 post-op/post-intervention

• Post- op labs as per standard of care

  FBC, U\&E, CRP

  Day 1-30 post-op/post-intervention

• Vital signs 24 hr

  Blood pressure, heart rate, respiration rate, oxygen saturations, temperature

  Day 1 post-op/post-intervention

• Presence or absence of postoperative nausea or vomiting

  Presence of nausea/vomiting in the post-op period

  Day 1 post-op/post-intervention

• Length of hospital stay

  Duration of hospital admission (hours)

  Day 1-30 post-op/post-intervention

• Any complications that were observed. Post-operative complications through 30 days, reported using Clavien-Dindo Classification, including 30-day mortality

  Reporting of post-operative complications

  Day 1-30 post-op/post-intervention

• Return to operating room within 24 hour

  Reason for return to the operating room and number of returns to operating room

  Day 1-30 post-op/post-intervention

• Readmission to hospital within 30 days

  Reason and number of readmissions to hospital

  Day 1-30 post-op/post-intervention

• All Adverse Events (intra-operative and post-operative through 30 days)

  Documented using the "Common Terminology Criteria for Adverse Events" (CTCAE) v5.0

  Day 1-30 post-op/post-intervention

Study Arms (2)

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.

Device: surgery

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.

Interventions

surgery DEVICE

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.

Also known as: Robotic assisted laparoscopic prostatectomy

Stryker PneumoClear insufflator

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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

Sponsors & Collaborators

• East and North Hertfordshire NHS Trust: lead

Study Sites (1)

Lister hospital

Stevenage, Hertfordshire, SG1 4AB, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma; Pain, Postoperative; Pain

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Nikhil Vasdev

CONTACT

07786657541; nikhil.vasdev@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: A prospective, randomized, controlled, open label, human clinical study designed to evaluate pain related to the use of the AirSeal® Insufflation System (AIS) vs a Stryker PneumoClear Insufflator for the management of pneumoperitoneum.

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: April 8, 2025
• Study Start: April 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)