Recovery After Emergency Laparotomy: a Prospective Observational Feasibility Study

Quality of Life Clinical Trial

— REmLap  

Official title:

Recovery After Emergency Laparotomy: a Prospective Observational Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02791633
• Other study ID #: REmLap
• Status: Completed
• Start date: July 10, 2017
• Est. completion date: January 31, 2022

Study information

• Verified date: March 2022
• Source: Dudley Group NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: January 31, 2022
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• >=18 years NELA Inclusion Criteria

Exclusion Criteria:

• Not willing to participate NELA Exclusion criteria

Related Conditions & MeSH terms

• Emergencies
• Postoperative Complications
• Quality of Life

Intervention

Other:
• Questionnaire
Quality of recovery and quality of recovery follow up questionnaires

Locations

Country	Name	City	State
United Kingdom	Russells Hall Hospital	Dudley	West Midlands

Sponsors (1)

Lead Sponsor	Collaborator
Dudley Group NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disability free survival	Disability free survival	1 year
Secondary	Change in Quality of life	Use of WHODAS-12, WHOQOL-BREF with specific symptom questionnaires	1 year
Secondary	Impact of surgical pathology type on disability free survival	Impact of surgical pathology type on disability free survival	1 year
Secondary	Impact of pre-operative Charlson Score on disability free survival	Impact of pre-operative Charlson Score on disability free survival	1 year