Peri-Operative Surgical Care Optimisation for Patients Requiring Emergency Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Quality of Life (QOL), Decision Making, Emergency General Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Quality of Life (QoL) [Time frame: 1 year]
- Decision-making [Time frame: 1 year]
Secondary outcome measures (4)
- Decision-making [Time frame: 1 year]
- Consultant specialities involved in decision-making [Time frame: 1 year]
- Patient Reported Outcome Measurements (PROMs) for Emergency General Surgery [Time frame: 1 year]
- Patient Reported Experience Measurements (PREMs) for Emergency General Surgery [Time frame: 1 year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06972017 · UGN23SG190 · PhD_23017