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OpenTrials
Completed

NCT Number: NCT02791633

Recovery After Emergency Laparotomy: a Prospective Observational Feasibility Study

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Russells Hall Hospital

Dudley, West Midlands, DY1 2HQ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >=18 years NELA Inclusion Criteria

Exclusion criteria

  • Not willing to participate NELA Exclusion criteria

Treatment and study plan

Questionnaire

Other

Quality of recovery and quality of recovery follow up questionnaires

Other names: WHODAS, SF36, QOR15, POMS

Primary outcomes

  1. Disability free survival

    Time frame: 1 year

    Disability free survival

Secondary outcomes

  1. Change in Quality of life

    Time frame: 1 year

    Use of WHODAS-12, WHOQOL-BREF with specific symptom questionnaires

  2. Impact of surgical pathology type on disability free survival

    Time frame: 1 year

    Impact of surgical pathology type on disability free survival

  3. Impact of pre-operative Charlson Score on disability free survival

    Time frame: 1 year

    Impact of pre-operative Charlson Score on disability free survival

Sponsors and collaborators

Lead sponsor

Dudley Group NHS Foundation Trust

Other

Registry information

Acronym: REmLap

Important dates

Study start
2017
Primary completion
2020
Study completion
2022
First posted
Jun 7, 2016
Registry last updated
Mar 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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