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Not yet recruitingNCT06972017PERI-SCOPESUpdated May 14, 2025

Peri-Operative Surgical Care Optimisation for Patients Requiring Emergency Surgery

An observational study in Quality of Life (QOL), Decision Making and Emergency General Surgery, sponsored by NHS Greater Glasgow and Clyde. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-14.

Sponsored by NHS Greater Glasgow and Clyde · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
112
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

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Keywords

  • Quality of Life
  • Decision-making
  • NoLap
  • EmLap
  • Emergency General Surgery
03

In context

Emergencies

1,692 studies on the registry are indexed under Emergencies; 332 are open to participants now.

This study's planned enrollment of 112 is below the median of 353 across 714 observational studies indexed under Emergencies.

Browse Emergencies studies →

Lead sponsor

NHS Greater Glasgow and Clyde is the lead sponsor of 215 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Eligibility criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
112 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

  2. 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.

    Time frame: 1 year

Secondary outcomes

  1. Decision-making

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

    Time frame: 1 year

  2. 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

    Time frame: 1 year

  3. 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.

    Time frame: 1 year

  4. 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.

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06972017
Lead sponsor
NHS Greater Glasgow and Clyde
Collaborators
Bowel Research UK, NHS Lothian, NHS Grampian, NHS Tayside, University of Glasgow
Responsible party
Sponsor
First posted
May 14, 2025
Start date
Jun 2025 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Dec 2027 (estimated)
Last update
May 14, 2025

Study contacts

Rachel John-Charles, MBChB, Bsc (Hons), MRSC
Contact
rachel.john-charles@nhs.scot
07962471992
Susan Moug, MBChB, Bsc (Hons), FRSC, PhD
Contact
susan.moug2@nhs.scot

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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