NCT02791633

Brief Summary

Observational feasibility study using Patient Reported Outcomes (PRO) to assess quality of life and 'return to normal life' up to 1 year following emergency laparotomy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

June 2, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 7, 2016

Completed
1.1 years until next milestone

Study Start

First participant enrolled

July 10, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

March 28, 2022

Status Verified

March 1, 2022

Enrollment Period

2.6 years

First QC Date

June 2, 2016

Last Update Submit

March 24, 2022

Conditions

Quality of LifePostoperative Complications

Outcome Measures

Primary Outcomes (1)

  • Disability free survival

    Disability free survival

    1 year

Secondary Outcomes (3)

  • Change in Quality of life

    1 year

  • Impact of surgical pathology type on disability free survival

    1 year

  • Impact of pre-operative Charlson Score on disability free survival

    1 year

Interventions

QuestionnaireOTHER

Quality of recovery and quality of recovery follow up questionnaires

Also known as: WHODAS, SF36, QOR15, POMS

Eligibility Criteria

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

All patients meeting NELA inclusion criteria (National Emergency Laparotomy Audit), undergoing Emergency Laparotomy at Russells Hall Hospital agreeing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Russells Hall Hospital

Dudley, West Midlands, DY1 2HQ, United Kingdom

Location

MeSH Terms

Conditions

Postoperative Complications

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Adrian Jennings

    Dudley Group NHSFT

    STUDY DIRECTOR

  • Rajan Patel

    DGNHSFT

    STUDY DIRECTOR

  • Faisal Baig

    DGNHSFT

    STUDY DIRECTOR

  • Peter Waterland

    DGNHSFT

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2016

First Posted

June 7, 2016

Study Start

July 10, 2017

Primary Completion

February 28, 2020

Study Completion

January 31, 2022

Last Updated

March 28, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)