Perioperative Medicine Clinical Trials Network
POMCTN supports the delivery of large scale perioperative trials in the UK
The UK Perioperative Medicine Clinical Trials Network (POMCTN) aims to create an environment which allows everyone with an interest in perioperative care to make a meaningful but realistic contribution to clinical trials and observational studies.
The UK Perioperative Medicine Clinical Trials Network (POMCTN or CTN) creates working relationships between trial organisers and investigators in individual hospitals, creating recognisable roles for every member of the group, even though POMCTN projects are usually large collaborations. The aim is to promote engagement with clinical trials and early implementation of the findings.
Overseen by the National Institute of Academic Anaesthesia, the POMCTN supports research projects involving the recruitment of patients where the aim is to improve outcomes following surgical treatment. This does not include research into surgical techniques except where these overlap with perioperative medicine. Our focus is on large clinical trials but some smaller studies will be appropriate for POMCTN support, especially if these are likely to translate into subsequent larger trials.
Register as an investigator
POMCTN currently offers four registration schemes for prospective researchers, which you can sign up for via the POMCTN website. Registration is free.
- Associate Investigator
The aim of the Associate scheme is to connect researchers, who are unlikely to be active in patient recruitment, to the members within the CTN. This is done by being kept informed about upcoming events and engaging in CTN activities.
- Local Investigator
The Local Investigator scheme is develops and supports individuals at local centres, to equip them with the training and skills to be co-investigators or trainee investigators in multicentre research trials.
- Principal Investigator
The aim of the Principal Investigator scheme is to develop and support individuals at local centres and to equip them with the training and skills to be local Principal Investigators for multi-centre research trials.
- Chief Investigator
The Chief Investigator scheme is designed for a very small number of leaders of future trials, around five at any one time, who are individually selected at competitive interview from amongst existing members of both the Local and Principal Investigator scheme.
Applicants will be able to select which scheme they wish to apply for at the time of registration, with the exception of the Chief Investigator Scheme, which is recruited to annually.
POMCTN expect most members of the Principal Investigator (PI) scheme to be consultant level; unless you expect to be eligible to act as a Principal Investigator on most POMCTN studies, you should apply for the Local Investigator scheme. This does not preclude acting as PI for individual studies.
Investigator applications are reviewed by CTN administration staff and Board members.
Participate in a POMCTN study
POMCTN aims to promote, support, design, and conduct multicentre collaborative research in anaesthesia, perioperative medicine, and pain medicine. To that end, investigators can submit their clinical trials for adoption by the Network, review by its Board and other members, and promotion to aid patient recruitment.
Click the links below for more on currently ongoing POMCTN studies:
POMCTN Adopted Studies
A placebo-controlled rAndomised trial of intravenous Lidocaine in acceLErating Gastrointestinal Recovery after cOlorectal surgery (ALLEGRO)
ALLEGRO aims to be the definitive trial to test whether 6-12 hours of perioperative IV lidocaine accelerates return of GI function after colorectal resection in the NHS. The primary study is powered to test the primary hypothesis in laparoscopic segmental colectomy and will recruit 562 patients from 12-15 hospitals over 3 years. We will also test the intervention in a parallel feasibility trial in open segmental colectomy patients using adaptive analysis to assess recruitment and effect size.
The primary study outcome will be return of gut function at 72 hours after surgery defined by a validated composite endpoint. Secondary outcomes will include other patient-reported aspects of recovery; pain scores and analgesia consumption; length of stay; safety endpoints; and health economic analysis.
ALLEGRO is funded by NIHR-HTA and has a website containing more information.
Fluid Optimisation in Emergency Laparotomy (FLO-ELA)
FLO-ELA is an open-label, multicentre, randomised controlled trial of cardiac output-guided haemodynamic therapy compared to usual care in patients undergoing emergency bowel surgery. It is the largest and most ambitious trial adopted by the POMCTN. FLO-ELA is a large pragmatic trial to evaluate the clinical effectiveness of perioperative cardiac output guided haemodynamic therapy in patients aged 50 years and over undergoing major emergency bowel surgery. We will compare this treatment to usual clinical care in 7646 patients across 100 UK hospitals.
FLO-ELA aims to recruit 7646 patients aged ≥50 years undergoing emergency laparotomy over 3 years, to confirm the clinical effectiveness of cardiac output-guided fluid therapy.
Nearly 50 hospitals have volunteered so far, many with POMCTN registered principal investigators, but we urgently need more hospitals to take part.
The trial is extremely simple with all the patient follow-up completed through the National Emergency Laparotomy Audit. Cardiac monitors and consumables will be provided. Trainees anaesthetists will play a vital role in FLO-ELA as many of the key additional tasks can be completed during the course of emergency theatre lists.
Find out more at www.floela.org and encourage your department to take part.
Effectiveness and cost-effectiveness of INSPIRatory musclE training (IMT) for reducing postoperative pulmonary complications (PPC): a sham-controlled randomised controlled trial (RCT) (INSPIRE)
After major operations, some patients develop complications of the lungs, including pneumonia. These complications can be serious and may result in long stays in hospital, admission to intensive care and even death. They also prolong recovery from surgery and reduce patients’ quality of life. In the long term, lung complications increase the risk of poor health and even death for up to ten years after surgery.
Poor health due to lung complications also increases healthcare costs. Lung complications are common, affecting on average one in ten patients, with the risk for a particular individual depending on their current health and the type of surgery they are having. Consequently, trying to prevent lung complications is important for patients and the National Health Service (NHS).
The main aim of the study is to compare the number of lung complications between the three groups in the first 30 days after surgery. We will record all lung complications that develop in hospital whilst patients are recovering from surgery and also any hospital admissions for a lung complication after patients are discharged from hospital following their operation. We will also compare the time patients spend in hospital, their quality of life after their operation and survival. The costs of any treatment received and time spent in hospital will also be compared between groups.
This trial is a prospective sham controlled randomised controlled trial to evaluate the effectiveness and cost-effectiveness of inspiratory muscle training (IMT) to reduce post operative pulmonary complications before major abdominal and cardiothoracic surgery.
Melatonin for Anxiety prior to General anaesthesia In Children (MAGIC)
Our first paediatric trial, MAGIC will be conducted in eight large NHS trusts (Sheffield, Barnsley, Leeds, Manchester, Liverpool, Aberdeen, Durham and Stoke) and aims to recruit between 21 and 180 participants per centre over an 18 month period. This study is to establish comparative effectiveness and side effect profile of melatonin versus midazolam as premedication in children aged 6-12 with high levels of preoperative distress prior to elective GA for dental extractions & ENT operations, and to determine whether melatonin offers sufficient benefit to warrant change in standard NHS practice.
MAGIC is a clinical trial of a medicinal product (CTIMP) so the trial paperwork and procedures are a little more stringent than some other trials and observational studies. For this reason, the trial is best led locally by a consultant who can play an active role. Your local R&D department will be able to guide you through the process. Please contact us if you would like us to connect you with the trial team.
Dental extractions and tonsillectomies compose the two most common operations for children undergoing general anaesthesia in the UK, accounting for 60,000 and 34,000 operations per year, respectively. Anxiety ahead of general anaesthesia is common, with up to 50% of children displaying manifestations of distress-behaviour at the point of anaesthetic induction. Anxiety and distress in a child may lead to non-compliance and result in rescheduling of elective surgery; it may furthermore lead to greater post-operative pain, agitation and behavioural changes after surgery including sleep disturbances.
Midazolam, the current standard premedication given to an anxious child ahead of surgery has been shown to be effective, although there are numerous adverse effects which make the medication less than ideal. One major consequence of benzodiazepine drugs such as midazolam is a sedative effect, which necessitates theatre transfer of the premedicated child, and also significantly delays post-operative recovery.
Further concerns include the potential for respiratory suppression and also unpredictable effects on children which may result in agitation rather than anxiolysis. The increased incidence of learning disabilities with repeated anaesthetic exposure has been documented in a landmark study by Wilder et al., which highlighted the potential long-term risks of using sedative agents such as benzodiazepines in anaesthesia of young children.
Optimisation of Perioperative Cardiovascular Management to Improve Surgical Outcome II (OPTIMISE II) Trial
Open, multi-centre, randomised controlled trial of cardiac output-guided fluid therapy with low dose inotrope infusion compared to usual care in patients undergoing major elective gastrointestinal surgery.
OPTIMISE II is a definitive large trial to evaluate the clinical effectiveness of peri-operative cardiac output guided haemodynamic therapy in high-risk patients aged 65 years and over undergoing major elective gastrointestinal surgery. It will compare this treatment to usual clinical care in 2502 patients across 50 hospitals worldwide. We aim to recruit 2502 patients in 50 hospitals worldwide, but we can only complete the trial on time with a strong contribution from the NHS.
Recruiting hospitals is particularly difficult because so many anaesthetists have strong beliefs that this treatment approach either does or does not work. Whilst we may think we know what the outcome will be, none of us knows for sure. We will struggle to improve the care of our patients unless we support projects which resolve difficult treatment decisions.
The study’s primary objective is to establish whether the use of minimally invasive cardiac output monitoring to guide protocolised administration of intra-venous fluid, combined with low dose inotrope infusion, will reduce the number of patients who experience a hospital-acquired infection within 30 days following major elective surgery involving the gastro-intestinal tract.
The secondary objectives will determine whether cardiac output-guided haemodynamic therapy reduces mortality, other forms of postoperative morbidity, improves quality of life and is cost-effective.
Optimising Shared decision-makIng for high-RIsk major Surgery (OSIRIS)
Each year in the NHS, 250,000 high-risk patients undergo major surgery. High-risk patients are typically older with long-term disease. They often experience serious medical problems after surgery, such as pneumonia or heart attacks, causing a lasting decline in health and quality of life.
This can occur even if surgery and anaesthesia have gone smoothly. Older patients with long-term health problems have different hopes and expectations of medical treatments, but these may not be understood by doctors. As a result, high-risk patients may not receive the information they need when contemplating surgery. We want to help patients better understand their risks, and choose the treatments that best suit them, by improving how they decide about surgery with their doctors.
The over-arching aim of the OSIRIS programme is to improve shared decision making for 250,000 high-risk patients undergoing major surgery each year in the NHS. High-risk patients are typically older with long-term disease.
They often experience serious medical problems after surgery, such as pneumonia or heart attacks, causing a lasting decline in health and quality of life. Older patients with long-term health problems have different hopes and expectations of medical treatments, but these may not be understood by doctors.
As a result, high-risk patients may not receive the information they need when contemplating surgery. We plan an integrated programme of research to co-design a decision support intervention, utilising a computational risk model, to provide an accurate and individualised forecast of the risks and benefits of surgery for each high-risk patient.
The clinical and cost-effectiveness of ThOracic epidural vs Paravertebral blockade In Chronic post-thoracotomy pain: multi-centre randomised controlled trial (TOPIC-2)
The study will be a randomised, parallel group, open, multicentre study in up to 20 UK thoracic centres.
One of the top 10 research priorities in anaesthesia and perioperative care from the James Lind Alliance is “what can we do to stop patients developing chronic pain after surgery?” As thoracotomy is a procedure with a high incidence of chronic pain, this is a good model to use. There is clinical uncertainty in the use of anaesthetic blockades in thoracotomy, with great variation in national practice.
Two main anaesthetic blockades are in use for thoracotomy: Thoracic Epidural Blockade (TEB) and Paravertebral blockade (PVB). In 2015, a Cochrane Review found no randomised comparisons of TEB versus PVB focusing on the outcome of chronic pain and highlighted the need for further research and high quality data.
The overall aim of this research is to determine in adult patients who undergo open thoracotomy whether perioperative paravertebral blockade (PVB) at thoracotomy results in reduced chronic post-thoracotomy pain compared to thoracic epidural blockade (TEB). To answer this research question with authoritative evidence of clinical and cost effectiveness of PVB, a multi-centre randomised controlled trial with a parallel health economic evaluation is required. Following a successful pilot study, we are looking to roll out a larger randomised trial.
Submit your own trial for adoption
The purpose of POMCTN adoption is to ensure excellence in study design, conduct, analysis and dissemination. Trial endorsement will provide the trial team access to the Network infrastructure, most importantly the membership of active local and principal investigators.
POMCTN supports research projects involving the recruitment of patients where the aim is to improve outcomes following surgical treatment. This does not usually include research into surgical techniques except where there is clear overlap with perioperative medicine. Our focus is on large clinical trials but smaller studies may be appropriate for POMCTN support, especially if these are likely to translate into subsequent larger trials.
The following conditions apply for the duration of an adopted trial and all predefined sub-studies:
- all POMCTN studies must be presented to the Network membership on at least one occasion prior to launch.
- the trial management group has the responsibility to obtain funding if not already secured and conduct the trial in accordance with POMCTN policies.
- all trials must be conducted to the highest professional standards, in compliance with codes of research conduct (Good Clinical Practice).
- the POMCTN must receive quarterly updates on trial progress and statistics.
Do you want to shape the future of UK perioperative trials?
Register as a POMCTN investigator now via their website and submit your own clinical trial proposals for adoption.
Rupert is a NIHR Research Professor and a consultant in intensive care medicine at Queen Mary University of London. He is an active researcher in perioperative medicine, with experience of leading several international projects to completion as chief investigator. His major interest is in perioperative medicine, but he is active in various fields in intensive care medicine and anaesthesia. His clinical work is all in intensive care medicine.
Joyce is a senior lecturer at University of Birmingham and honorary consultant in anaesthesia and critical care. My research into the impact of anaesthesia on post-operative delirium in patients with hip fracture has been awarded a NIHR post- doctoral fellowship. Her current research focuses on the impact of anaesthesia on cognitive function, the elderly, patient outcomes and development of chronic pain post surgery.