Not Yet Recruiting

NCT Number: NCT06972017

Peri-Operative Surgical Care Optimisation for Patients Requiring Emergency Surgery

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Quality of Life (QOL) Decision Making Emergency General Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Quality of Life (QoL)

Time frame: 1 year

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.
Decision-making

Time frame: 1 year

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.

Secondary outcomes

Decision-making

Time frame: 1 year

Semi-structured interviews with patients and families/supporters will allow us to explore their experience and views of decision-making in EGS.
Consultant specialities involved in decision-making

Time frame: 1 year
Workstream 1 will clarify which specialties are involved in the EGS decision-making process to allow recruitment for workstream 2.

We will specifically clarify the number of EGS decisions which involve
- consultant surgeon
- consultant anaesthetist
- consultant intestivist
Patient Reported Outcome Measurements (PROMs) for Emergency General Surgery

Time frame: 1 year

The results from workstream 1 will inform the development of PROMs for EGS. These PROMS will include a number of specific EGS related questions developed from our study results.
Patient Reported Experience Measurements (PREMs) for Emergency General Surgery

Time frame: 1 year

The results from workstream 1 will inform the development of PREMs for EGS. These PREMS will include a number of specific EGS related questions developed from our study results.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

07962471992

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

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

NHS Greater Glasgow and Clyde

Other

Collaborators

Bowel Research UK
NHS Grampian
NHS Lothian
NHS Tayside
University of Glasgow

Registry information

Acronym: PERI-SCOPES

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2027
First posted: May 14, 2025
Registry last updated: May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting