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Recovery After Emergency Laparotomy: a Prospective Observational Feasibility Study

Recovery After Emergency Laparotomy: a Prospective Observational Feasibility Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02791633
Acronym
REmLap
Enrollment
75
Registered
2016-06-07
Start date
2017-07-10
Completion date
2022-01-31
Last updated
2022-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Complications, Quality of Life

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

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.

Interventions

OTHERQuestionnaire

Quality of recovery and quality of recovery follow up questionnaires

Sponsors

Dudley Group NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

\- \>=18 years NELA Inclusion Criteria

Exclusion criteria

\- Not willing to participate NELA

Design outcomes

Primary

MeasureTime frameDescription
Disability free survival1 yearDisability free survival

Secondary

MeasureTime frameDescription
Change in Quality of life1 yearUse of WHODAS-12, WHOQOL-BREF with specific symptom questionnaires
Impact of surgical pathology type on disability free survival1 yearImpact of surgical pathology type on disability free survival
Impact of pre-operative Charlson Score on disability free survival1 yearImpact of pre-operative Charlson Score on disability free survival

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026