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

Sponsor
Dudley Group NHS Foundation Trust (Other)
Overall Status
Completed
CT.gov ID
NCT02791633
Collaborator
(none)
75
1
54.7
1.4

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
75 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Recovery After Emergency Laparotomy: a Prospective Observational Feasibility Study
Actual Study Start Date :
Jul 10, 2017
Actual Primary Completion Date :
Feb 28, 2020
Actual Study Completion Date :
Jan 31, 2022

Outcome Measures

Primary Outcome Measures

  1. Disability free survival [1 year]

    Disability free survival

Secondary Outcome Measures

  1. Change in Quality of life [1 year]

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

  2. Impact of surgical pathology type on disability free survival [1 year]

    Impact of surgical pathology type on disability free survival

  3. Impact of pre-operative Charlson Score on disability free survival [1 year]

    Impact of pre-operative Charlson Score on disability free survival

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • =18 years NELA Inclusion Criteria

Exclusion Criteria:
  • Not willing to participate NELA Exclusion criteria

Contacts and Locations

Locations

Site City State Country Postal Code
1 Russells Hall Hospital Dudley West Midlands United Kingdom DY1 2HQ

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dudley Group NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT02791633
Other Study ID Numbers:
  • REmLap
First Posted:
Jun 7, 2016
Last Update Posted:
Mar 28, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 28, 2022