Clinical trial NCT06972017: Peri-Operative Surgical Care Optimisation for Patients Requiring Emergency Surgery
Official title: Peri-Operative Surgical Care Optimisation for Patients Requiring Emergency Surgery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Quality of Life (QOL)
Decision Making
Emergency General Surgery
Keywords: Quality of Life
Decision-making
NoLap
EmLap
Emergency General Surgery
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: Bowel Research UK
name: NHS Lothian
name: NHS Grampian
name: NHS Tayside
name: University of Glasgow
First posted: 2025-05-14
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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: Group 1 and 2: EmLap and NoLap patients (up to 30 participants)

Patient inclusion/exclusion criteria should mirror NELA inclusion/exclusion criteria and NELA NoLap guidelines. NELA is the "National Emergency Laparotomy Audit" which recruits patients in Wales and England and there inclusion/exclusion criteria are widely accepted for use in Emergency General Surgery research.

Inclusion criteria

* Age \>65 years old
* Able to communicate in English
* Cognitively able to complete the survey/interviews
* Able to provide informed, voluntary consent
* First line treatment is expedited, urgent or emergency abdominal surgery on the gastrointestinal tract
* Surgery can be laparoscopic or open approach

Exclusion criteria

* Age \<65 years old
* NoLaps should be excluded if management involved interventional radiology or endoscopic procedures
* Patients who are offered a period of conservative treatment are not automatically NoLap if surgery may ultimately be offered
* Diagnosis of dementia or long-standing cognitive impairment
* Elective laparotomy/laparoscopy
* Diagnostic laparotomy/laparoscopy where no subsequent procedure is performed (however, if no procedure is performed because of inoperable pathology, then include)
* All surgery involving the appendix or gallbladder, including any surgery relating to complications
* Non-elective hernia repair without bowel resection or division of adhesions
* Non-elective formation of colostomy or ileostomy
* Trauma surgery (blunt or penetrating), vascular surgery, obstetric/gynaecological surgery or transplant surgery
* Surgery for pathology of oesophagus, spleen, renal tract, kidneys, liver, gallbladder and biliary tree, pancreas or urinary tract

Group 3: Families/Supporters (up to 30 participants) Inclusion criteria

* Identified by the patient participant (only approached if nominated by patient)
* Age \>18 years old
* Able to communicate in English
* Cognitively able to complete the survey/interviews
* Able to provide informed, voluntary consent

Exclusion criteria

* Age\<18 years old
* Lack of patient consent to family/supporter involvement

Group 3: Consultants (interview:12-20 participants/survey: minimum 52 participants) Inclusion criteria

* Key decision-makers will be identified in workstream 1 (likely: surgeons, intensivists and anaesthetists)
* Post-CCT (Certificate of Completion of Training)
* Participate in active on-call for EGS in a UK-based Hospital where they make decisions in EGS regularly

Exclusion criteria

• Consultants not done \>2 years of on-call

Primary outcomes:
measure: Quality of Life (QoL)
timeFrame: 1 year
measure: Decision-making
timeFrame: 1 year
Secondary outcomes:
measure: Decision-making
timeFrame: 1 year
measure: Consultant specialities involved in decision-making
timeFrame: 1 year
measure: Patient Reported Outcome Measurements (PROMs) for Emergency General Surgery
timeFrame: 1 year
measure: Patient Reported Experience Measurements (PREMs) for Emergency General Surgery
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References: