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CompletedNCT02791633REmLapUpdated Mar 28, 2022

Recovery After Emergency Laparotomy: a Prospective Observational Feasibility Study

An observational study in Quality of Life and Postoperative Complications, sponsored by Dudley Group NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-28.

Sponsored by Dudley Group NHS Foundation Trust · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
75
Ages
18 Years and older
Sex
All
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Study 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

Read the 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.

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Conditions studied

  • Quality of Life
  • Postoperative Complications
03

In context

Postoperative Complications

1,269 studies on the registry are indexed under Postoperative Complications; 299 are open to participants now.

This study's enrollment of 75 is below the median of 251 across 531 observational studies indexed under Postoperative Complications.

Browse Postoperative Complications studies →

Lead sponsor

Dudley Group NHS Foundation Trust is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

- >=18 years NELA Inclusion Criteria

Exclusion criteria

Exclusion Criteria:

- Not willing to participate NELA Exclusion criteria

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
75 participants (actual)
Patient registry
No

Interventions

  • OtherQuestionnaire

    Quality of recovery and quality of recovery follow up questionnaires

    Also known as: WHODAS, SF36, QOR15, POMS

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What researchers measure

Primary outcomes

  1. Disability free survival

    Disability free survival

    Time frame: 1 year

Secondary outcomes

  1. Change in Quality of life

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

    Time frame: 1 year

  2. Impact of surgical pathology type on disability free survival

    Impact of surgical pathology type on disability free survival

    Time frame: 1 year

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

    Impact of pre-operative Charlson Score on disability free survival

    Time frame: 1 year

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Study locations

1 site
  • Russells Hall Hospital
    Dudley, West Midlands DY1 2HQ, United Kingdom
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02791633
Lead sponsor
Dudley Group NHS Foundation Trust
Responsible party
Sponsor
First posted
Jun 7, 2016
Start date
Jul 10, 2017
Primary completion
Feb 28, 2020
Completion
Jan 31, 2022
Last update
Mar 28, 2022

Study contacts

Adrian Jennings
study director · Dudley Group NHSFT
Rajan Patel
study director · DGNHSFT
Faisal Baig
study director · DGNHSFT
Peter Waterland
study director · DGNHSFT

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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