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Clinical Trials/NCT02791633
NCT02791633CompletedNot Applicable

Recovery After Emergency Laparotomy: a Prospective Observational Feasibility Study

Dudley Group NHS Foundation Trust1 site in 1 country75 target enrollmentStarted: July 10, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
75
Locations
1
Primary Endpoint
Disability free survival

Study Overview

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

Detailed Description

Regaining baseline Health Related Quality of Life (HRQoL) and returning to 'normal life' after surgery are of vital importance for patients. Knowledge of the trajectory and degree of long-term functional recovery following emergency laparotomy, including the regaining of optimal HRQoL is limited as most research relating to this field has been done in patients undergoing planned surgery. Furthermore, a comprehensive understanding of the pattern of recovery and restoration of baseline HRQoL is also important to researchers wishing to assess the full impact of interventions in order to improve outcomes following emergency laparotomy. Assessing HRQoL in this surgical population remains a challenge in the absence of a validated instrument. The investigators plan to undertake a feasibility study to assess utilisation of four patient questionnaires, well established within other surgical populations, to describe the quality of early and long-term recovery following emergency laparotomy. The investigators will utilise the QoR-15 to describe short-term (in - hospital) recovery metrics and versions of the WHO-DAS and the WHOQOL-BREF to describe longer term disability free survival and return towards baseline HRQoL. The Post-Operative Morbidity Survey (POMS) will help capture the onset of complications at different points during recovery. The study also aims to test the feasibility of assessing the impact of pre-operative co-morbidities, age, quality of peri-operative and intra-operative care, surgical indication and findings as well as post-operative complications on long-term HRQoL.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • >=18 years NELA Inclusion Criteria

Exclusion Criteria

  • Not willing to participate NELA Exclusion criteria

Outcomes

Primary Outcomes

Disability free survival

Time Frame: 1 year

Disability free survival

Secondary Outcomes

  • 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)

Investigators

Sponsor
Dudley Group NHS Foundation Trust
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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