Recovery After Emergency Laparotomy: a Prospective Observational Feasibility Study (REmLap)

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

Study Overview

• Status: Completed
• Conditions: Quality of Life; Postoperative Complications
• Intervention / Treatment: Other: Questionnaire

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 Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• United Kingdom
  • West Midlands
    • Dudley, West Midlands, United Kingdom, DY1 2HQ
      • Russells Hall Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

- >=18 years NELA Inclusion Criteria

Exclusion Criteria:

- Not willing to participate NELA Exclusion criteria

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disability free survival	Disability free survival	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dudley Group NHS Foundation Trust
• Investigators: Study Director: Adrian Jennings, Dudley Group NHSFT; Study Director: Rajan Patel, DGNHSFT; Study Director: Faisal Baig, DGNHSFT; Study Director: Peter Waterland, DGNHSFT

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 10, 2017
• Primary Completion (ACTUAL): February 28, 2020
• Study Completion (ACTUAL): January 31, 2022

Study Registration Dates

• First Submitted: June 2, 2016
• First Submitted That Met QC Criteria: June 2, 2016
• First Posted (ESTIMATE): June 7, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 28, 2022
• Last Update Submitted That Met QC Criteria: March 24, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Postoperative Complications
• Other Study ID Numbers: REmLap

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No