Peri-Operative Surgical Care Optimisation for Patients Requiring Emergency Surgery

NCT06972017 | Not Yet Recruiting

• 2 other identifiers: UGN23SG190PhD_23017
• Study Type: observational
• Target: 112
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Quality of Life (QOL); Decision Making; Emergency General Surgery

Keywords

Quality of Life; Decision-making; NoLap; EmLap; Emergency General Surgery

Outcome Measures

Primary Outcomes (2)

• 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.

  1 year

• 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.

  1 year

Secondary Outcomes (4)

• Decision-making

  1 year

• Consultant specialities involved in decision-making

  1 year

• Patient Reported Outcome Measurements (PROMs) for Emergency General Surgery

  1 year

• Patient Reported Experience Measurements (PREMs) for Emergency General Surgery

  1 year

Study Arms (4)

EmLap patients

Patients who have underwent Emergency General Surgery

NoLap patients

Patients who have needed but not undergone Emergency General Surgery.

Families/Supporters

Family or supporter nominated by the patient participant to participate in the study alongside them.

Consultants

Consultants who actively participate in Emergency General Surgery in a UK-based Hospital (Surgeons, Anaesthetists, Intensivists)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• Bowel Research UK: collaborator
• NHS Lothian: collaborator
• NHS Grampian: collaborator
• NHS Tayside: collaborator
• University of Glasgow: collaborator

Central Study Contacts

Rachel John-Charles, MBChB, Bsc (Hons), MRSC

CONTACT

07962471992; rachel.john-charles@nhs.scot

Susan Moug, MBChB, Bsc (Hons), FRSC, PhD

CONTACT

susan.moug2@nhs.scot

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: May 14, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 14, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share