Project Cheetah
CHEETAH is an international, multicentre, 2-arm, cluster randomised controlled trial with an internal pilot to evaluate the use of separate sterile gloves and instruments for wound closure to reduce SSI rates in patients undergoing surgery with an abdominal incision.
Recruitment for this trial closed on the 31/03/2022 after 22 months – 2 months ahead of schedule.
Read the latest publication here. Previous publications can be found here.
CHEETAH is, after FALCON, the second global surgical trial from the NIHR-GSU network.
7
COUNTRIES
81
RANDOMISED HOSPITALS
0
ACTIVE HOSPITALS
(Trial now closed)
13331
PATIENTS RECRUITED
Nothing found.
Background
Surgical site infection (SSI) represents a major burden for patients, doctors and health systems around the world, but is potentially preventable. SSI is the most common postoperative complication across all income and development settings, and the most common healthcare-associated infection in low-and middle-income countries (LMICs). It has been associated with one-third of postoperative deaths and accounts for 8% of all deaths caused by a nosocomial infection. Rates vary significantly between different types of surgery, but it is particularly prevalent in abdominal operations; as many as one in four patients get an SSI when the operation involves the bowel.
Improving surgical outcomes is a global health priority, highlighted by the Lancet Commission on Global Surgery. Recent WHO guidelines made 29 recommendations for intraoperative and postoperative measures to prevent SSI. Despite inclusion of strongly graded recommendations, there was little high-quality evidence in support of most interventions. In addition, none of the evidence used was derived from resource limited settings, leading to uncertainty about implementation of measures in LMICs, in particular. The specific interventions to be tested in this study were selected by a Delphi process from a long list of potential interventions based on the the WHO guidelines.
A key factor influencing SSI rates is intraoperative contamination (opening the gut, genital or urinary tracts). In clean (non-contaminated) surgery, the infection rate is low and benefits from research targeting SSI rates in those patients are limited. CHEETAH will therefore focus on clean-contaminated, contaminated and dirty surgery. A cluster randomised design is considered the most appropriate design to minimise the risk of contamination in the control arm of the trial. Once theatre staff have been trained to implement the intervention (of separating sterile surgical instruments and gloves at the time of wound closure) it is likely to become routine practice, making individual randomisation unfeasible.
Aims & Objectives
Primary Objective
The primary objective of the CHEETAH RCT is to assess whether the practice of using separate, sterile gloves and instruments to close wounds at the end of surgery can reduce surgical site infection at 30-days post-surgery for patients undergoing clean-contaminated, contaminated or dirty abdominal surgery, compared to current routine hospital practice.
Secondary Objective
The secondary objective of the CHEETAH RCT is to assess the impact of changing gloves/instruments prior to wound closure compared to current routine hospital practice on secondary clinical outcomes up to 30 days post-surgery including: SSI during the in-hospital stay, re-admission, re-operation, length of hospital stay, return to normal activities, and death.
The recruitment target is a total of 12,800 participants from 64 clusters (hospital), each including up to 200 participants.
Collaborating Countries
CHEETAH is an international trial being conducted in multiple NIHR funded countries. Click on the map below to see participating countries.
Surgical site infection (SSI) represents a major burden for patients, doctors and health systems around the world, but is potentially preventable. SSI is the most common postoperative complication across all income and development settings, and the most common healthcare-associated infection in low-and middle-income countries (LMICs). It has been associated with one-third of postoperative deaths and accounts for 8% of all deaths caused by a nosocomial infection. Rates vary significantly between different types of surgery, but it is particularly prevalent in abdominal operations; as many as one in four patients get an SSI when the operation involves the bowel.
Improving surgical outcomes is a global health priority, highlighted by the Lancet Commission on Global Surgery. Recent WHO guidelines made 29 recommendations for intraoperative and postoperative measures to prevent SSI. Despite inclusion of strongly graded recommendations, there was little high-quality evidence in support of most interventions. In addition, none of the evidence used was derived from resource limited settings, leading to uncertainty about implementation of measures in LMICs, in particular. The specific interventions to be tested in this study were selected by a Delphi process from a long list of potential interventions based on the the WHO guidelines.
A key factor influencing SSI rates is intraoperative contamination (opening the gut, genital or urinary tracts). In clean (non-contaminated) surgery, the infection rate is low and benefits from research targeting SSI rates in those patients are limited. CHEETAH will therefore focus on clean-contaminated, contaminated and dirty surgery. A cluster randomised design is considered the most appropriate design to minimise the risk of contamination in the control arm of the trial. Once theatre staff have been trained to implement the intervention (of separating sterile surgical instruments and gloves at the time of wound closure) it is likely to become routine practice, making individual randomisation unfeasible.
To assess whether the practice of using separate sterile gloves and instruments to close wounds at the end of surgery compared to current routine hospital practice can reduce surgical site infection at 30-days post-surgery for patients undergoing clean-contaminated, contaminated or dirty abdominal surgery.
CHEETAH is an international, multicentre, 2-arm, cluster randomised controlled trial, with an internal pilot. Clusters are defined as hospitals, which means hospitals rather than patients are randomised.
Patients (adults and children) undergoing emergency or elective abdominal surgery for a clean-contaminated, contaminated or dirty operation.
The intervention used within CHEETAH is:
Change of gloves and use of separate, sterile instruments before closing the abdominal wall
Comparator (current routine hospital practice):
No change of gloves or use of separate, sterile instruments before closing the abdominal wall
The CHEETAH trial has a 12 month internal pilot of 12 clusters and approximately 600 participants to assess:
- Whether hospitals adhere to their allocation
- What proportion of patients who are eligible for CHEETAH can be followed up successfully at 30 days after their surgery
Countries:
- LMICs defined by the Development Assistance Committee (DAC) Official Development Assistance (ODA) list where there are at least 4 eligible hospitals per country
- At least four eligible hospitals per country
Hospitals (clusters):
- Hospitals where glove and instrument change is not currently routine hospital practice
Participants:
a. Emergency (surgery on an unplanned admission) or elective (surgery on a planned admission)
b. Intraoperative finding of clean-contaminated, contaminated or dirty surgery
c. With at least one abdominal incision that is ≥5cm
- Patients aged xx years and over on the day of surgery. NB: This criteria must be made country-specific. This will be dependant on country-specific regulatory approvals.
Sponsor
The University of Birmingham (UoB) is the sponsor of the CHEETAH trial in collaborating countries.
International Coordinating Centre
The International Coordinating Centre CHEETAH trial office is at the University of Birmingham Clinical Trials Unit (BCTU).
Each country will appoint a National Coordinating Investigator (NCI) and a National Coordinating Centre (NCC) – the Hub – who will take national responsibility for the study. The Hubs will be responsible for coordinating recruitment from a range of representative local hospitals – spokes.
Central and National Trial Management Group
The Central Trial Management Group (CTMG) includes those individuals responsible for the day-to-day management of the trial. This will include the trial CI, lead methodologists, patient representatives and CHEETAH central trial management staff.
Trial Steering Committee
The Trial Steering Committee provides overall supervision of the trial and ensures that the trial is being conducted in accordance with the principles of Good Clinical Practice and other relevant regulations.
Data Monitoring Committee
The Data Monitoring Committee will give advice on whether the accumulated data from the trial, together with the results from other relevant research, justifies the continuing recruitment of further participants.
Central Trial Management Group (University of Birmingham)
CHEETAH Trial Team
Birmingham Clinical Trials Unit, Public Health Building
University of Birmingham, Edgbaston, B15 2TT
Email: Cheetah@trials.bham.ac.uk
Tel: from UK 0121 415 9103, International +44121 415 9103
Twitter: @cheetahRCT
Project Crane
CRANE: Feasibility of a cluster randomised study of a nutritional intervention to improve outcomes after cancer surgery in low-income countries.
CRANE is a feasibility study funded by the UK Medical Research Council.:
0
CONTINENTS
0
COUNTRIES
0
HOSPITALS
0
PATIENTS RECRUITED
Background
Following GlobalSurg 3, our international cohort study examining surgical outcomes for cancer patients, CRANE will be the first high quality global trial of a nutritional supplement given to malnourished patients prior to cancer surgery in low & middle income countries.
It is estimated that two-thirds of patients undergoing cancer surgery in low- and middle-income countries (LMICs) are malnourished. Increasingly it is being recognised that boosting the health of patients before surgery can greatly improve the chances of a successful operation. The CRANE Study will be investigating the benefit of intensively treating patients in LMICs with nutritional supplements prior to surgery.
Aims & Objectives
Primary Objective
Objective 1: to identify and validate a nutritional screening tool relevant to patients in LMICs
Objective 2: to identify a low cost sustainable nutritional intervention for cancer surgery patients in LMICs
Objective 3: to test the feasibility of patient recruitment, retention & nutritionational supplement acceptability
Collaborating Countries
Crane is feasibility study being conducted in 3 partner countries
For many types of cancer, high quality surgery is the only cure. This is particularly true in low-income countries where treatments such as chemotherapy or radiotherapy may not be available.
Malnutrition is a major public health issue in LMICs, with as many as two-thirds of hospitalised adults being malnourished. Cancer often causes extreme weight loss and, in many countries, this occurs on top of pre-existing malnutrition. Malnutrition is associated with higher post-operative mortality and morbidity, including longer length of inpatient stay and increased healthcare-associated costs.
It has been demonstrated that perioperative nutrition in patients undergoing gastrointestinal cancer surgery can halve postoperative complications, reduce post-operative stay and significantly impact on surgery-associated mortality. Nutritional supplementation provided at the time of surgery in LMICs could provide a low cost and sustainable intervention, requiring minimal specialist training and equipment to administer.
GlobalSurg 3 is providing data that will allow us to establish the relationship between malnutrition and surgical outcomes in a way that hasn’t been possible previously, but to find a solution to the problem we need a large scale trial testing nutritional interventions prior to surgery.
The CRANE trial is a feasibility study designed to bridge the gap between the GlobalSurg 3 observational study and a large scale clinical trial.
Systematic reviews and guided focus groups will be used to establish a suitable malnutrition screening tool and to identifying the most appropriate nutritional intervention to deliver, including patient acceptability.
A pilot trial will investigate whether patient recruitment and retention is achievable in a trial of this nature, and test methods of data collection.
Establishing all of these things in a feasibility study will inform the design of a large scale cluster randomised controlled trial in the future.
Adults undergoing surgery for gastrointestinal and breast cancer at 20 hospital in Ghana, Pakistan, Philippines and Zambia
CRANE is a cluster randomised trial; it is randomised at the level of the institution, rather than at patient level.
Project Eagle
EAGLE: ESCP Safe-anastomosis Programme in Colorectal Surgery.
0
CONTINENTS
0
COUNTRIES
0
HOSPITALS
0
PATIENTS RECRUITED
Background
The ESCP Safe-anastomosis Programme in Colorectal Surgery (EAGLE) is an international, cluster randomised-sequence study of a Safe-anastomosis Quality Improvement Intervention to reduce anastomotic leak following right colectomy and ileocaecal resection.
Anastomotic leak is a severe, potentially life-threatening complication following right colectomy. Internationally, anastomotic leak occurs after 8% of right colectomies. Prospective cohort data demonstrate that patient selection, intraoperative factors, and technical variation are risk factors for anastomotic leak.
The Eagle trial is the latest and most ambitious of the global ‘snap shot studies’ that the European Society of Coloproctology (ESCP) has run over the past five years. The study consists of interactive, online training modules for surgeons and theatre teams and will assess whether implementation of the ESCP Safe-anastomosis intervention reduces risk of anastomotic leak rate.
Overall, we are aiming to collaborate with more than 2,000 surgeons in over 300 hospitals across the world, including 4,500 patients in total.
You can find out more about EAGLE, including how to get involved at https://is.gd/EAGLEsitesetup
Aims & Objectives
Primary Objectives
- Preoperative risk stratification – making sure for each patient that anastomosis is safe for them.
- Harmonisation of surgical technique – making the best anastomosis possible and checking it carefully after it is created.
- Implementation of an intra-operative anastomosis checklist – focusing the attention of the whole theatre team at this critical stage of the operation.
Collaborating Countries
EAGLE will collaborate with researchers in high, middle and low income countries all around the world. Hospitals across Europe, South East Asia, South America, the USA, Saudi Arabia, North Africa and Russia have already registered to participate.
Anastomotic leak is a severe, potentially life-threatening complication following right colectomy. Internationally, anastomotic leak occurs after 8% of right colectomies. Prospective cohort data demonstrate that patient selection, intraoperative factors, and technical variation are risk factors for anastomotic leak
To assess whether implementation of the ESCP Safe-anastomosis intervention reduces risk of anastomotic leak rate.
International, multi-centre, cluster randomised-sequence service improvement study, with the hospital as the cluster. Phased Dog-leg schedule for repeated assessments with 3 randomisation sequences. Meta-analysis of results will be performed from individual dog legs (indicatively four dog legs).
Any hospital or surgical unit performing elective and/or emergency colorectal surgery. Adults (age 18 years and above) undergoing right colectomy or ileocaecal resection for any indication are eligible, including elective, expedited or emergency surgery by open, laparoscopic or robotic approaches.
30-day overall anastomotic leak rate, defined as clinical or radiologically detected anastomotic leak or intra-abdominal or pelvic collection.