Quality of LifeREmLapNCT02791633
Recovery After Emergency Laparotomy: a Prospective Observational Feasibility Study
An observational study of Quality of Life and Postoperative Complications, run by Dudley Group NHS Foundation Trust at 1 site in United Kingdom.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Postoperative Complications
- What is being tested?
- Questionnaire
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jul 2017to 31 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients meeting NELA inclusion criteria (National Emergency Laparotomy Audit), undergoing Emergency Laparotomy at Russells Hall Hospital agreeing to participate
Who may be able to join
- >=18 years NELA Inclusion Criteria
Who cannot join
- Not willing to participate NELA Exclusion criteria
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Russells Hall Hospital
Dudley, West Midlands, DY1 2HQ
About this study
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.
- Conditions
- Quality of Life, Postoperative Complications
- Being tested
- Questionnaire
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Also called WHODAS, SF36, QOR15, POMS
Quality of recovery and quality of recovery follow up questionnaires
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability free survival
Disability free survival
Measured: 1 year
Secondary outcomes (3)
Change in Quality of life
Use of WHODAS-12, WHOQOL-BREF with specific symptom questionnaires
Measured: 1 year
Impact of surgical pathology type on disability free survival
Impact of surgical pathology type on disability free survival
Measured: 1 year
Impact of pre-operative Charlson Score on disability free survival
Impact of pre-operative Charlson Score on disability free survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study start10 Jul 2017
- Primary completion28 Feb 2020
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dudley Group NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrian Jennings, Study director, Dudley Group NHSFTRajan Patel, Study director, DGNHSFTFaisal Baig, Study director, DGNHSFTPeter Waterland, Study director, DGNHSFT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791633
- Sponsor's protocol ID
- REmLap
- Acronym
- REmLap
- Status last verified
- Mar 2022
- First submitted
- 2 Jun 2016
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery After Emergency Laparotomy: a Prospective Observational Feasibility Study
- ClinicalTrials.gov ID
- NCT02791633
- Acronym / sponsor ID
- REmLap / REmLap
- Conditions
- Quality of Life, Postoperative Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Dudley Group NHS Foundation TrustUniversity, hospital or other
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 7 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients meeting NELA inclusion criteria (National Emergency Laparotomy Audit), undergoing Emergency Laparotomy at Russells Hall Hospital agreeing to participate
Key inclusion criteria (1 listed)
- >=18 years NELA Inclusion Criteria
Key exclusion criteria (1 listed)
- Not willing to participate NELA Exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAlso: WHODAS, SF36, QOR15, POMSQuality of recovery and quality of recovery follow up questionnaires | Other | – |
Primary outcome
Disability free survival
Time frame: 1 year
Disability free survival
3 secondary outcomes
Change in Quality of life
Time frame: 1 year
Impact of surgical pathology type on disability free survival
Time frame: 1 year
Impact of pre-operative Charlson Score on disability free survival
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian Jennings study director
Dudley Group NHSFT
Rajan Patel study director
DGNHSFT
Faisal Baig study director
DGNHSFT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Postoperative Complications, run by Dudley Group NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability free survival (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2022.