Peri-Operative Surgical Care Optimisation for Patients Requiring Emergency Surgery

NCT ID: NCT06972017

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 112 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2027-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

EmLap patients

Patients who have underwent Emergency General Surgery

No interventions assigned to this group

NoLap patients

Patients who have needed but not undergone Emergency General Surgery.

No interventions assigned to this group

Families/Supporters

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

No interventions assigned to this group

Consultants

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

No interventions assigned to this group

Eligibility Criteria

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

• 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

• 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

• 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

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

• Consultants not done >2 years of on-call

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bowel Research UK

UNKNOWN

Sponsor Role: collaborator

NHS Lothian

OTHER_GOV

Sponsor Role: collaborator

NHS Grampian

OTHER_GOV

Sponsor Role: collaborator

NHS Tayside

OTHER_GOV

Sponsor Role: collaborator

University of Glasgow

OTHER

Sponsor Role: collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

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

Role: CONTACT

rachel.john-charles@nhs.scot

07962471992

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

Role: CONTACT

susan.moug2@nhs.scot

Other Identifiers

PhD_23017

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

UGN23SG190

Identifier Type: -

Identifier Source: org_study_id