NCT03534765

Brief Summary

  1. 1.A retrospective scoping cohort review of adult patients undergoing emergency laparotomy/laparoscopy for acute gastrointestinal (GI) pathology who have had a CT scan of the abdomen(+/- pelvis). CT measured sarcopenia would be compared with clinical outcomes, 30-day and 1-year mortality.
  2. 2.A prospective observational cohort study and bio-banking exercise of routinely collected clinical data, in a cohort of patient undergoing emergency laparotomy/laparoscopy or conservative treatment for an otherwise operable pathology. An interrogation of CT measured sarcopenia and a validated clinical frailty score would be analysed against clinical outcomes, 30-day and 1-year mortality.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
294

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 23, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

January 10, 2019

Status Verified

January 1, 2019

Enrollment Period

6 months

First QC Date

March 27, 2018

Last Update Submit

January 9, 2019

Conditions

Frail Elderly SyndromeEmergenciesSurgerySarcopenia

Keywords

LaparotomyFrailtySacropenia

Outcome Measures

Primary Outcomes (1)

  • 30-day mortality

    Deaths (all cause) within 30 days of surgical procedure

    30 days post surgery

Secondary Outcomes (6)

  • 1 year mortality

    1 year post surgery

  • Length of stay

    Reported at 30 days after surgical procedure

  • Post-operative morbidity

    30 days post surgery

  • Destination of discharge from hospital

    End of initial hospital inpatient care episode. Closes at time of discharge within 30 days of surgical procedure)

  • Hospital readmission

    30 days after discharge

  • +1 more secondary outcomes

Study Arms (2)

Retrospective arm

Retrospective multicentre cohort with 1 year outcomes available following emergency surgery for NELA eligible gastrointestinal pathology. Please refer to WP1 inclusion and exclusion criteria for eligibility.

Diagnostic Test: CT abdomen +/- pelvisProcedure: Emergency laparotomy for general surgical pathology

Prospective, multicentre arm

10 centre prospective observational arm. Please refer to WP2 inclusion and exclusion criteria for eligibility.

Diagnostic Test: CT abdomen +/- pelvisDiagnostic Test: Edmunton Frailty ScoreProcedure: Emergency laparotomy for general surgical pathology

Interventions

CT abdomen +/- pelvisDIAGNOSTIC_TEST

Diagnostic CT scan (only if requested by responsible clinicians)

Prospective, multicentre armRetrospective arm
Edmunton Frailty ScoreDIAGNOSTIC_TEST

Patient completed previously valided questionnaire quantifying frailty.

Prospective, multicentre arm
Emergency laparotomy for general surgical pathologyPROCEDURE

Emergency general surgical laparotomy (defined by the UK NELA body)

Prospective, multicentre armRetrospective arm

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Acute general surgical patients presenting with gastrointestinal pathology deemed eligible for NELA who have undergone a diagnostic CT scan of the abdomen (or abdomen and pelvis) who are scheduled to either undergo either operative or non-operative interventions.

You may qualify if:

  • Adults age over 18
  • Route of admission should include all general surgical admission or referrals via emergency department, interdepartmental transfers, direct referrals and GP referrals to an acute general surgical team.
  • All patients are required to have had a CT scan abdomen or abdomen and pelvis, supine or prone, with or without contrast.
  • All patients are required to have a completed REFS.
  • Those treated with operative measure (NCEPOD criteria) or those that would be treated operatively as an emergency, expedited, or urgently on the GI tract including:
  • Laparoscopic, open, converted or laparoscopic assisted
  • Surgical or radiological procedure or conservative treatments for pathology involving the stomach, small bowel, large bowel as a result of perforation, obstruction, ischaemia, bleeding or abscess.
  • Washout or evacuation of intrabdominal haematoma or abscess
  • Laparotomy or laparoscopy with no intervention due to inoperable pathology where the intention was to perform definition intervention.
  • Bowel resection or repair or conservative treatment due to obstructed or incarcerated incisional umbilical femoral or inguinal hernia.
  • Bowel resection/repair or conservative treatment due to obstructing/incarcerated incisional hernias provided the presentation and findings were acute. This will include large incisional hernia repair with division of adhesions.
  • Laparoscopic/Open Adhesiolysis or conservative treatment for bowel obstruction
  • Return to theatre for repair of substantial dehiscence of major abdominal wound (i.e. "burst abdomen")

You may not qualify if:

  • If multiple procedures are performed on different anatomical sites within the abdominal/pelvic cavity, the patient would be included if the major procedure is general surgical.
  • Non-elective colonic resection with hysterectomy for a fistulating colonic cancer would be included as the bowel resection is the major procedure
  • Bowel resection at the same time as emergency abdominal aortic aneurysm repair would not be included as the aneurysm repair is the major procedure
  • The subjects are required to have had an acute admission, inpatient stay, formal ward admission, review and diagnosis of acute GIT surgical pathology under an acute surgical team.
  • Patients less than 18 years old
  • Ambulant or day case admission or outpatient admission only
  • No review from an acute surgical team.
  • Prisoners or patients under arrest or on remand.
  • Isolated gynaecology pathology: pathology of the ovaries, uterus or tubal systems not involving the gastrointestinal tract(GIT) i.e ectopic pregnancy.
  • Isolated urology acute abdomen: pathology of the kidneys, ureters or bladder not involving the GIT i.e pyelonephritis, lower urinary tract infections, renal or ureteric stones, bladder malignancy
  • Isolated vascular pathology I.e Ruptured aortic aneurysm with no GIT ischaemia, iliac aneurysmal disease.
  • Excluded uncomplicated appendicectomy, cholecystectomy and ventral wall, or inguinal hernia.
  • Elective laparotomy / laparoscopy
  • Diagnostic laparotomy/laparoscopy where no subsequent procedure is performed (NB, if no procedure is performed because of inoperable pathology, the case is included).
  • Appendicectomy +/- drainage of localised collection unless the procedure is incidental to a non-elective procedure on the GI tract
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Hampshire Hospitals NHS Foundation Trust

Basingstoke, United Kingdom

RECRUITING

Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

Bournemouth, United Kingdom

RECRUITING

Dorset County Hospital NHS Foundation Trust

Dorchester, United Kingdom

RECRUITING

Isle of Wight NHS Trust

Newport, United Kingdom

RECRUITING

Poole Hospital NHS Foundation Trust

Poole, United Kingdom

RECRUITING

Portsmouth Hospitals NHS Trust

Portsmouth, United Kingdom

RECRUITING

Salisbury NHS Foundation Trust

Salisbury, United Kingdom

RECRUITING

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

RECRUITING

Hampshire Hospitals NHS Foundation Trust

Winchester, United Kingdom

RECRUITING

Yeovil District Hospital NHS Foundation Trust

Yeovil, United Kingdom

RECRUITING

MeSH Terms

Conditions

EmergenciesSarcopeniaFrailty

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalSigns and Symptoms

Study Officials

  • Malcolm West, MD PhD MRCS

    University of Southampton

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Viki Waldren

CONTACT

+44 238120 5663victoria.waldren@uhs.nhs.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Fellow

Study Record Dates

First Submitted

March 27, 2018

First Posted

May 23, 2018

Study Start

October 1, 2018

Primary Completion

March 31, 2019

Study Completion

August 1, 2020

Last Updated

January 10, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

No sharing plan

Locations

GB(10)