Clinical trial NCT02791633: Recovery After Emergency Laparotomy: a Prospective Observational Feasibility Study
Official title: Recovery After Emergency Laparotomy: a Prospective Observational Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Postoperative Complications
Lead sponsor: Dudley Group NHS Foundation Trust
Sponsor class: OTHER
First posted: 2016-06-07
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients meeting NELA inclusion criteria (National Emergency Laparotomy Audit), undergoing Emergency Laparotomy at Russells Hall Hospital agreeing to participate

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.

Eligibility criteria: Inclusion Criteria:

- \>=18 years NELA Inclusion Criteria

Exclusion Criteria:

- Not willing to participate NELA Exclusion criteria

Primary outcomes:
measure: Disability free survival
timeFrame: 1 year
Secondary outcomes:
measure: Change in Quality of life
timeFrame: 1 year
measure: Impact of surgical pathology type on disability free survival
timeFrame: 1 year
measure: Impact of pre-operative Charlson Score on disability free survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Dudley
country: United Kingdom
facility: Russells Hall Hospital
state: West Midlands
Study officials:
affiliation: Dudley Group NHSFT
name: Adrian Jennings
role: STUDY_DIRECTOR
affiliation: DGNHSFT
name: Rajan Patel
role: STUDY_DIRECTOR
affiliation: DGNHSFT
name: Faisal Baig
role: STUDY_DIRECTOR
affiliation: DGNHSFT
name: Peter Waterland
role: STUDY_DIRECTOR
References: