MAS PROMs, version 1.0
Research type
Research Study
Full title
Patient reported outcomes after major abdominal surgery
IRAS ID
315644
Contact name
Ramani Moonesinghe
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
DPO, Z6364106/2023/11/128 medical research
Duration of Study in the UK
0 years, 10 months, 1 days
Research summary
About 4 in 10 people will have major abdominal surgery (MAS) in their lifetime. Such an operation can have a profound impact on physical function, mental health and socio-economic function. Currently used markers to monitor patients following MAS do not asses these effects. An alternative is to use patient reported outcome measures (PROMs) that can evaluate any aspect of patient’s health. Unfortunately, there are no PROMs that can be used to monitor patients after major abdominal surgery. The aim of this study is to develop and validate PROMs that will measure recovery following major abdominal surgery.
Our study includes adult patients (≥18 years of age) of all genders and ethnicities, from all socio-economic groups. The reason for major abdominal surgery could be a benign or malignant condition in elective or emergency setting. The only pre-requisite is participant’s ability to read and speak English for this phase of the study. We will not be including any children. We are unable to include adults, who cannot consent due to cognitive impairment or lack of capacity. At this stage, we are unable to include participants, who cannot communicate, read or understand English language. However, these participants will be recruited in further stages, when the PROMs are translated.
We will recruit patients from the NHS and private healthcare setting (HCA UK Healthcare) to ensure that the sample is representative of the target population. The study will involve in-depth interviews focused on participants’ experience of recovery following surgery or a set of questions within a newly developed PROMs questionnaire, depending on the phase of the study. It is anticipated that the study will conclude by February 2025 with the dissemination of results completed by February 2026.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
24/NW/0196
Date of REC Opinion
2 Aug 2024
REC opinion
Further Information Favourable Opinion