Peri-Operative Surgical Care Optimisation for Patients Requiring Emergency Surgery (PERI-SCOPES)

NHS Trust

Status

Not yet enrolling

Conditions

Decision Making

Quality of Life (QOL)

Emergency General Surgery

Study type

Observational

Funder types

Other

Identifiers

NCT06972017

PhD_23017 (Other Grant/Funding Number)

UGN23SG190

Details and patient eligibility

About

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.

Enrollment

112 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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