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"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Recruitment rates
研究概览
简要总结
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.
An amendment has been approved to recruit an additional 60 participants, total overall recruitment is 100.
详细描述
In this trial, 100 patients undergoing robotic prostatectomies will be randomised to have either the AIRSEAL® Insufflation System (AIS) or the Stryker PneumoClear Insufflator devices used to maintain pneumoperitoneum during surgery. Data relating to intra-operative and post-operative pain will be collected. This data will be used to identify any differences in outcomes between the two arms of the trial.
The main aim of this feasibility study will be to inform the feasibility and design of a subsequent definitive full-scale trial. The feasibility trial will collect data about recruitment, study conduct, and assessment methods. The objectives of the feasibility are to
- Assess recruitment rates
- Evaluate whether the study can run in line with the study protocol
- Identify the feasibility of collecting clinical data
- 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
- Estimate the likely magnitude of the effect of the intervention. To allow for estimation of the sample size for the full trial
The subsequent large scale, multi-center trial following this feasibility trial will focus on severity of pain during and immediately after surgery in the recovery room and then by 6-hour increments, measured by a 0 - 10 Numeric Rating Scale (NRS) and a PMD-200 nociception non-invasive monitor as the primary outcome
Secondary outcomes include:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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);
排除标准
- •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
研究组 & 干预措施
Stryker PneumoClear insufflator
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.
干预措施: surgery (Device)
AirSeal® Insufflation System
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.
结局指标
主要结局
Recruitment rates
时间窗: 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.
时间窗: Through study completion estimated to be 6-12 months
Pre-op vitals
时间窗: Baseline/day 1
Bloods pressure, heart rate, oxygen saturations, respiration rate, temperature
Pre-op BMI (height and weight)
时间窗: Baseline/day 1
kg/m\^2
Pre-op labs
时间窗: Baseline/day 1
Pre-op FBC, U\&E, CRP and PSA bloods
Insufflation Pressure
时间窗: Perioperative
Intraoperative insufflation pressure (mmHg)
Estimated blood loss
时间窗: Perioperative
Estimated intra-operative blood loss (ml)
Blood transfusion
时间窗: Perioperative
Intra-operative blood transfusions (number of units of blood e.g 0, 1, 2, 3 etc...)
Procedure time (initial incision to closure)
时间窗: Perioperative
Number of minutes from incision to closure
Surgeon-determined need to increase IAP beyond "study pressure"
时间窗: Perioperative
Need to increase insufflation pressure intra-operatively (mmHg)
Administration of transversus abdominis plane block
时间窗: Perioperative
Was a transversus abdominis plane block administered (yes or no)
Anesthetic/pain medication administration
时间窗: Perioperative
Intra-operative administration of analgesia (morphine milligram equivalent units)
MedaSense PMD-200 monitor for pain documentation
时间窗: Perioperative
Intra-operative pain score (NOL score 0-100)
Intraoperative Peak Airway Pressure every 15 minutes
时间窗: Perioperative
Intra-operative PAP (cmH2O)
Intraoperative End Tidal Carbon Dioxide (ETCO2) every 15 minutes
时间窗: Perioperative
Intra-operative ETCO2 (mmHg)
Time in recovery room
时间窗: Perioperative
Number of minutes spent in post-op recovery
Post-op pain incidence and severity
时间窗: Day 1-30 post-op/post-intervention
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.
Post-op analgesia usage
时间窗: Day 1-30 post-op/post-intervention
Post-op analgesia usage on discharge (morphine milligram equivalent units)
Post- op labs as per standard of care
时间窗: Day 1-30 post-op/post-intervention
FBC, U\&E, CRP
Vital signs 24 hr
时间窗: Day 1 post-op/post-intervention
Blood pressure, heart rate, respiration rate, oxygen saturations, temperature
Presence or absence of postoperative nausea or vomiting
时间窗: Day 1 post-op/post-intervention
Presence of nausea/vomiting in the post-op period
Length of hospital stay
时间窗: Day 1-30 post-op/post-intervention
Duration of hospital admission (hours)
Any complications that were observed. Post-operative complications through 30 days, reported using Clavien-Dindo Classification, including 30-day mortality
时间窗: Day 1-30 post-op/post-intervention
Reporting of post-operative complications
Return to operating room within 24 hour
时间窗: Day 1-30 post-op/post-intervention
Reason for return to the operating room and number of returns to operating room
Readmission to hospital within 30 days
时间窗: Day 1-30 post-op/post-intervention
Reason and number of readmissions to hospital
All Adverse Events (intra-operative and post-operative through 30 days)
时间窗: Day 1-30 post-op/post-intervention
Documented using the "Common Terminology Criteria for Adverse Events" (CTCAE) v5.0
次要结局
未报告次要终点