Recent Grant Success
The Bristol Trials Centre has recently had a number of successful grant applications, and work has begun to set up these studies to start in 2022. In this article, we present information relating to two of these new studies; ROSE and CAMELOT.
ROSE: Impact of feedback from Real-time, electronic symptom monitoring on post discharge recOvery after Surgery for oEsophago-gastric cancer: a multicentre randomised controlled trial
Chief Investigator: Kerry Avery
To find out if patients recovering at home from surgery for oesophago-gastric (food pipe or stomach) cancer benefit from feedback following electronic web-based reporting and monitoring of their symptoms.
Around 12,500 people in England are diagnosed with oesophago-gastric (OG) cancer each year and around a fifth of these have surgery. Patients tend to stay in hospital for 1-2 weeks after surgery. Even when well enough to continue their recovery at home, patients may still experience surgery-related problems or feel unwell with symptoms such as pain or tiredness. There is growing evidence from patients undergoing other cancer treatments (such as chemotherapy) that electronic (i.e., web-based) reporting of symptoms can improve wellbeing, because it provides a simple way to give feedback to patients and their care team about how best to manage symptoms. However, this has not been studied in patients undergoing surgery for cancer.
We will invite 210 patients having surgery for OG cancer at six NHS hospitals in England to take part. Patients will be randomly placed in one of two groups. Patients in the ‘web-based monitoring and feedback’ group will be asked to report their symptoms using the web-based system while continuing to receive their usual clinical care. Depending on the seriousness of reported symptoms, the system will immediately provide feedback to the patient about selfcare, advise them to contact their care team, or send an automatic alert to their care team. Patients in the ‘usual care’ group will receive their usual clinical care but will not use the web-based system to report symptoms or receive feedback.
All patients will complete questionnaires during the study, including before their surgery, while in hospital after surgery, and at several timepoints up to four weeks after going home from hospital. We will use the questionnaire answers to see if patients in the ‘web-based monitoring and feedback’ group have a better recovery from their surgery than those in the usual care group. We will also look at whether the web-based system is good value for money to the NHS.
This study/project is funded by the National Institute for Health Research (RfPB programme NIHR201483). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
CAMELOT: Continuous rectus sheath Analgesia in eMErgency LaparOTomy Multi-centre, randomised sham-controlled trial of rectus sheath catheter-delivered local anaesthetic infusion compared with usual care in patients undergoing emergency bowel surgery
Chief Investigator: Mark Edwards
The study will find out whether adding rectus sheath catheters (RSCs) to standard patient-controlled analgesia (PCA) provides better pain relief, fewer side effects and complications, and greater satisfaction for patients undergoing emergency laparotomy surgery (a cut to the abdomen). It will also determine whether RSCs are safe and cost-effective.
In the UK around 30,000 patients a year undergo an operation called an emergency laparotomy to
treat life-threatening conditions. A large vertical cut is made in the abdomen when patients are asleep under general anaesthesia. Good pain relief after surgery will help patients feel better and recover quicker. Because of the high level of pain experienced by many patients, opioid based painkillers such as morphine are often given, using PCA pumps.
However, morphine can cause serious side effects such as breathing problems, nausea and vomiting, and delayed bowel movement, all of which can slow patient recovery. RSCs are a newer way of providing pain relief, where two thin tubes (catheters) are inserted on either side of the wound during the operation. Local anaesthetic is injected slowly into the catheters to numb the nerves and reduce pain for about three days. Small studies suggest that RSCs may provide effective pain relief, reduce post-operative use of morphine, and help patient recovery. Potential disadvantages are that RSCs take time to insert and are expensive. More work is needed to understand whether there are any unwanted effects when using RSCs.
We will recruit 750 patients into the study over three years from 15 NHS hospitals. Patients will be randomly assigned to one of two groups: one group will have RSCs plus standard PCA, and the other will have standard PCA only. In the PCA only group, identical-looking catheters will be attached on the skin surface, but no local anaesthetic will be given. This means that patients will report their post-operative pain and other side effects without knowing which group they are in.
We will compare the two groups using the Overall Benefit of Analgesia Score. This score measures pain, opioid side effects and patient satisfaction, and will be completed by the patient daily for five days after surgery. We will also compare the speed of patients’ recovery from surgery and look for relevant postoperative complications such as breathing problems. We will check for long-term pain six months after surgery, measure costs to the NHS and the impact on patients’ return to activities (e.g. work).
This project is funded by the National Institute for Health Research (HTA programme (NIHR133554). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
REPROVIDE #ChangeChampions Recruitment Campaign
It’s estimated that 1 in 4 women will experience domestic abuse in their lifetimes. Interventions have been developed for victims and survivors, however evidence-based interventions for those who carry out domestic abuse are needed to tackle the root cause of the abuse. This is reflected in the recent Domestic Abuse Bill.
REPROVIDE is a randomised controlled trial testing the effectiveness and cost effectiveness of a group programme for men who are concerned about their abusive behaviour in relationships with women. The trial was awarded National Urgent Public Health Priority Status by the National Institute for Health Research. Unfortunately, recruitment has been affected by the pandemic and so the trial team have been working hard to re-build awareness of the programme in recent months.
In a new #ChangeChampions campaign, REPROVIDE has teamed up with three of the region’s leading football clubs and charitable organisations; Bristol Rovers, Bath City FC and Newport’s County in The Community. The campaign aims to tell men who want to change their behaviour in relationships that it’s OK to ask for help, and to encourage them to consider participating in REPROVIDE. The team spoke about the campaign on BBC Points West on Tuesday 26th October, along with two men who have taken part in the research themselves. More information about REPROVIDE and the #ChangeChampions can be found in the below resources:
- Twitter: @ReprovideUoB
- Facebook: Behaviour.Change.for.Men
- Website: https://reprovideprogramme.blogs.bristol.ac.uk/changechampions/
“This research was funded by the National Institute for Health Research (NIHR) (RP-PG-0614-20012 REPROVIDE (Reaching Everyone Programme of Research On Violence in diverse Domestic Environments) project reference) using UK aid from the UK Government to support global health research. The views expressed in this publication are those of the author(s) and not necessarily those of the NIHR or the UK Department of Health and Social Care.”
New study aiming to reduce winter infections in care homes is looking for participating sites
Study manager: Dr Rachel Brierley
The AFRI-c (Air Filters to Prevent Respiratory Infections including COVID-19 in Care Homes) study will investigate the effectiveness of portable air filters in preventing respiratory infections (such as coughs, colds and flu) and COVID-19 among care home residents in England.
There are currently 220,000 people aged over 65 living in UK care homes. This number is predicted to double by 2040 and, as highlighted by the devastating effects of COVID-19 in care homes, reducing the spread of infections in care homes is a high priority.
Many infections are spread via droplets produced when people sneeze or cough. The droplets can be inhaled or picked up from surfaces. Portable air filters are a possible way to reduce the spread of infections, as those that contain high efficiency particulate air (HEPA) filters can quickly remove germs from the air. These filters are built into hospital operating theatres and transplant wards to prevent infections. HEPA filters are now built into some portable units available for domestic use, and can easily be placed in care homes.
The AFRI-c study will divide 74 care homes into two groups at random. The 37 care homes in the control group will continue with usual care, following their local infection prevention strategies such as hand-washing. The 37 care homes in the intervention group will continue with usual care, and in addition place HEPA air filters in communal areas and up to ten residents’ private bedrooms for seven months over the winter (September to April). The study is expected to run over 3 winters (until 2024). Care home staff will record the number of infections their residents experience during this period, and the results from the two groups will be compared.
Professor Alastair Hay, AFRI-c Chief Investigator from the University of Bristol’s Centre for Academic Primary Care, said: “Our research has [previously] shown portable air filters are capable of removing viruses and other germs from the air, but there have been no studies to investigate the benefits on human health, so AFRI-c is the first of its kind. The study also aims to understand if the purchase and use of air filters represents good value for money. We are particularly interested to hear from care homes and care home chains in England who might be interested in helping us. Please visit the AFRI-c study website to find out more about taking part.”
For further information about the study, which started autumn 2021, please email: firstname.lastname@example.org
Funder acknowledgement: This project is funded by the National Institute for Health Research (NIHR) Public Health Research (PHR) Programme (NIHR PHR 129783). The views expressed are those of the author(s) and not necessarily those of the NIHR. This study was designed and delivered in collaboration with the Bristol Randomised Trials Collaboration (BRTC), a UKCRC registered clinical trials unit which, as part of the Bristol Trials Centre, is in receipt of NIHR CTU support funding. This study is sponsored by the University of Bristol.
The Bristol Oxford Surgical Trials Intervention course (BOSTiC) is a joint initiative between the Bristol and Oxford Surgical Trials Units. In September 2021 they successfully ran a 3-day surgical research training event on surgical trials for foundation, core and specialist trainees of all surgical specialities. Students worked collaboratively to learn how to design and conduct RCTs in surgery that answer research questions of relevance to surgeons, patients and the NHS.
You can watch the new promotional video to find out more, or visit the website.
Members of the INSPIRE study team (including the Chief Investigator Dr Maria Pufulete) recently published a meta-analysis providing a summary of all types of preoperative “prehabilitation” techniques (including inspiratory muscle training (IMT)) in patients undergoing major surgery. This project found that some “prehabilitation” techniques, including IMT, can reduce the length of postoperative hospital stay by 1.8 days and reduce the rate of postoperative lung-related complications by 45%. The full article has recently been published in BMJ Open and can be accessed here.
You can read more about the INSPIRE study here.
This study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme (HTA) Reference Number 16/140/07. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.