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Recovery After Emergency Laparotomy: a Prospective Observational Feasibility Study

NCT ID: NCT02791633

Last Updated: 2022-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-10

Study Completion Date

2022-01-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Quality of Life Postoperative Complications

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Questionnaire

Quality of recovery and quality of recovery follow up questionnaires

Intervention Type OTHER

Other Intervention Names

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WHODAS, SF36, QOR15, POMS

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria:

\- \>=18 years NELA Inclusion Criteria

Exclusion Criteria:

\- Not willing to participate NELA Exclusion criteria
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dudley Group NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adrian Jennings

Role: STUDY_DIRECTOR

Dudley Group NHSFT

Rajan Patel

Role: STUDY_DIRECTOR

DGNHSFT

Faisal Baig

Role: STUDY_DIRECTOR

DGNHSFT

Peter Waterland

Role: STUDY_DIRECTOR

DGNHSFT

Locations

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Russells Hall Hospital

Dudley, West Midlands, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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REmLap

Identifier Type: -

Identifier Source: org_study_id

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