Recovery After Emergency Laparotomy: a Prospective Observational Feasibility Study

Completed

• Conditions: Quality of Life; Postoperative Complications

• Registration Number: NCT02791633
• Lead Sponsor: Dudley Group NHS Foundation Trust

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 Timeline

• Study First Submitted: 2016-06-02
• Study First Submitted QC: 2016-06-02
• Study First Posted: 2016-06-07
• Study Start: 2017-07-10
• Primary Completion: 2020-02-28
• Study Completion: 2022-01-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-24
• Last Update Posted: 2022-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• >=18 years NELA Inclusion Criteria

Exclusion Criteria

• Not willing to participate NELA Exclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disability free survival	1 year	Disability free survival

Secondary Outcome Measures

Name	Time	Method
Change in Quality of life	1 year	Use of WHODAS-12, WHOQOL-BREF with specific symptom questionnaires
Impact of surgical pathology type on disability free survival	1 year	Impact of surgical pathology type on disability free survival
Impact of pre-operative Charlson Score on disability free survival	1 year	Impact of pre-operative Charlson Score on disability free survival

Trial Locations

Locations (1)

Russells Hall Hospital; 🇬🇧 Dudley, West Midlands, United Kingdom