Peri-Operative Surgical Care Optimisation for Patients Requiring Emergency Surgery

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNHS Greater Glasgow and Clyde

About this trial

Emergency General Surgery (EGS) is an umbrella term which describes all patients presenting to hospital with an acute abdominal problem. Patients can have various conditions requiring emergency operations. EGS is one of the most common reasons for an emergency admission in the UK.

EGS is often referred to as "high-risk" surgery. For those patients who do survive after their surgery, many struggle with frailty and new medical problems resulting in a reduction in their quality of life (QoL).

The goal of this observational study is to explore QoL and decision-making in EGS through questionnaires and interviews with patients, families/supporters and consultants working in EGS.

Workstream 1 will involve patients and families/supporters. Workstream 2 will involve consultants.

The investigators are interested in patients who have either undergone EGS (EmLaps) or have needed but not undergone EGS (NoLaps). The investigators are interested in exploring participants (patients, families/supporters and consultants) experiences of this EmLap vs NoLap decision.

The main questions the investigators want to answer are:

* What is the long-term QOL of EmLap/NoLap patients and their family/supporters? * How do patients and their family/supporters describe their experience of decision-making in EGS? * What are consultant's experiences and views on decision-making in EGS?

Workstream 1 participants (patients and family members/supporters) will complete questionnaires and take part in interviews at different time-points following their decision (1 month/3 months/ 9-12 months). Questionnaires and interviews will explore QoL and decision-making in EGS.

Consultant participants will be asked to complete an online survey and/or take part in an individual interview. Both will explore decision-making in EGS.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Age >65 years old

Able to communicate in English

Cognitively able to complete the survey/interviews

Able to provide informed, voluntary consent

Trial population

Project will recruit EmLap and NoLap patients from the 6 sites across Scotland with the highest EmLaps per year (Queen Elizabeth University Hospital, Glasgow Royal Infirmary, Royal Alexandra Hospital, Aberdeen Royal Infirmary, Ninewells Hospital, Edinburgh Royal Infirmary). Consultants will be recruited from UK only.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

112 Participants
are grouped into 4 trial groups
Group A: EmLap patients
Group B: NoLap patients
Group C: Families/Supporters
Group D: Consultants

Trial outcomes

Primary outcomes

1

Quality of Life (QoL)

The primary aim of workstream 1 is to report on the long-term QoL of EmLap and NoLap patients and their families/supporters. For this, participants will complete validated QoL questionnaires within 4 weeks of EmLap/NoLap decision then again at 3 and 9-12 months post-decision. Questionnaires will include European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) which will specifically quantify QoL. Maximum score= 1. Minimum scores in the UK have been reported at -0.28. A higher score reflects a higher QoL.

Time frame
1 year
2

Decision-making

The primary aim of workstream 2 is to describe and explore consultant experiences of decision-making in EGS through online survey and semi-structured interviews.

Time frame
1 year

Secondary outcomes

1

Decision-making

Semi-structured interviews with patients and families/supporters will allow us to explore their experience and views of decision-making in EGS.

Time frame
1 year
2

Consultant specialities involved in decision-making

Workstream 1 will clarify which specialties are involved in the EGS decision-making process to allow recruitment for workstream 2. We will specifically clarify the number of EGS decisions which involve * consultant surgeon * consultant anaesthetist * consultant intestivist

Time frame
1 year
3

Patient Reported Outcome Measurements (PROMs) for Emergency General Surgery

The results from workstream 1 will inform the development of PROMs for EGS. These PROMS will include a number of specific EGS related questions developed from our study results.

Time frame
1 year
4

Patient Reported Experience Measurements (PREMs) for Emergency General Surgery

The results from workstream 1 will inform the development of PREMs for EGS. These PREMS will include a number of specific EGS related questions developed from our study results.

Time frame
1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NHS Greater Glasgow and Clyde

Lead sponsor

Bowel Research UK

Collaborator

NHS Lothian

Collaborator

NHS Grampian

Collaborator

NHS Tayside

Collaborator

University of Glasgow

Collaborator

This trial is not recruiting at the moment. You can still explore other options: