Quality of Life (QOL)PERI-SCOPESNCT06972017
Peri-Operative Surgical Care Optimisation for Patients Requiring Emergency Surgery
An observational study of Quality of Life (QOL) and Decision Making, run by NHS Greater Glasgow and Clyde.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life (QOL), Decision Making, Emergency General Surgery
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Show all 24Show fewer
- 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
- 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
- Consultants not done >2 years of on-call
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Susan Moug, MBChB, Bsc (Hons), FRSC, PhD contact
About this study
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).
Read more
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.
- Keywords
- Quality of Life, Decision-making, NoLap, EmLap, Emergency General Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Secondary outcomes (4)
Decision-making
Semi-structured interviews with patients and families/supporters will allow us to explore their experience and views of decision-making in EGS.
Measured: 1 year
Consultant specialities involved in decision-making
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
Measured: 1 year
Patient Reported Outcome Measurements (PROMs) for Emergency General Surgery
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.
Measured: 1 year
Patient Reported Experience Measurements (PREMs) for Emergency General Surgery
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study startJun 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of Life (QOL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- Bowel Research UK, NHS Lothian, NHS Grampian, NHS Tayside, University of Glasgow
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972017
- Sponsor's protocol ID
- UGN23SG190
- Other IDs
- PhD_23017
- Acronym
- PERI-SCOPES
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Psuedonymized personal data will retained only for as long as required for processing (1 year after project has ended). Only depersonalised anonymous research data will be stored for a longer period of time and shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-Operative Surgical Care Optimisation for Patients Requiring Emergency Surgery
- ClinicalTrials.gov ID
- NCT06972017
- Acronym / sponsor ID
- PERI-SCOPES / UGN23SG190
- Keywords
- Quality of Life, Decision-making, NoLap, EmLap, Emergency General Surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- Bowel Research UK, NHS Lothian, NHS Grampian, NHS Tayside, University of Glasgow
- Study start
- Jun 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No. Psuedonymized personal data will retained only for as long as required for processing (1 year after project has ended). Only depersonalised anonymous research data will be stored for a longer period of time and shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susan Moug, MBChB, Bsc (Hons), FRSC, PhD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life (QOL) and Decision Making, run by NHS Greater Glasgow and Clyde.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel John-Charles, MBChB, Bsc (Hons), MRSC (07962471992, rachel.john-charles@nhs.scot), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (QoL) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.