Peri-Operative Surgical Care Optimisation for Patients Requiring Emergency Surgery

Обзор

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.

Первичные конечные точки

• Quality of Life (QoL) [Срок оценки: 1 year]
• Decision-making [Срок оценки: 1 year]

Вторичные конечные точки (4)

• Decision-making [Срок оценки: 1 year]
• Consultant specialities involved in decision-making [Срок оценки: 1 year]
• Patient Reported Outcome Measurements (PROMs) for Emergency General Surgery [Срок оценки: 1 year]
• Patient Reported Experience Measurements (PREMs) for Emergency General Surgery [Срок оценки: 1 year]

Критерии участия

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.

Критерии включения

• 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

Критерии исключения

• 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

Критерии исключения

• 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

Критерии исключения

• Consultants not done >2 years of on-call

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06972017 · UGN23SG190 · PhD_23017

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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