SurgeryNCT02824783
Quality of Life After Enhanced Recovery Protocol for Colorectal Surgery
An observational study of Surgery, run by University of Liege at 1 site in Belgium.
Trial summary
The aim of the study is to investigate the quality of life and satisfaction of patient who underwent colorectal surgery using an enhanced recovery protocol when back home. In this retrospective study patients will be telephoned and asked to answer a questionnaire. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgery
- How many people
- 41 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2016to Jul 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all patients included in our GRACE database since the 1st of October 2015
Who may be able to join
- all patients included in our GRACE database
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality of Life and Satisfaction of Patients Discharged Home After Enhanced Recovery Protocol for Colorectal Surgery
The aim of the study is to investigate the quality of life and satisfaction of patient who underwent colorectal surgery using an enhanced recovery protocol when back home.
In this retrospective study patients will be telephoned and asked to answer a questionnaire.
Read the detailed description
Since October 1st 2015, our center has been labelled reference center for colorectal surgery using Enhanced Recovery Protocol (ERP) by GRACE (Groupe francophone de Rehabilitation après ChirurgiE; a francophone counterpart of ERAS® society). In case of ERP, the quality of life when the patient is at home is not well known. Some argue that patient might experience discomfort and lack of autonomy, particularly elderly patient if discharged home too quickly.
In this study, the investigators will call our patients introduced in the database of GRACE to assess the quality of life and patient satisfaction concerning our ERP. Eight domains will be investigated: information, stress, feelings when discharged home, pain, fatigue, autonomy, feeding problems, and satisfaction.
When analyzing the results the investigators will pay a particular attention to elderly patients (age > 70 yo) to determine whether these experience more difficulties as compared to younger patients.
- Conditions
- Surgery
- Keywords
- colorectal surgery, enhanced recovery
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life (0 to ten numeric scale + questionnaire)
0 to ten numeric scale + questionnaire
Measured: first month after leaving the hospital
Secondary outcomes (3)
Satisfaction (0 to ten numeric scale + questionnaire)
0 to ten numeric scale + questionnaire
Measured: first month after leaving the hospital
Pain (0 to ten numeric scale + questionnaire)
0 to ten numeric scale + questionnaire
Measured: first month after leaving the hospital
Fatigue (0 to ten numeric scale + questionnaire)
0 to ten numeric scale + questionnaire
Measured: first month after leaving the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startJan 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean François Brichant, University of Liege
- Investigators
- Jean Joris, M.D., Principal investigator, Department of Anesthesiology, CHU Liege, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824783
- Sponsor's protocol ID
- GRACE1
- Status last verified
- Dec 2017
- First submitted
- 25 Jun 2016
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Satisfaction of Patients Discharged Home After Enhanced Recovery Protocol for Colorectal Surgery
- ClinicalTrials.gov ID
- NCT02824783
- Acronym / sponsor ID
- GRACE1
- Conditions
- Surgery
- Keywords
- colorectal surgery, enhanced recovery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 7 Jul 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.
The aim of the study is to investigate the quality of life and satisfaction of patient who underwent colorectal surgery using an enhanced recovery protocol when back home.
In this retrospective study patients will be telephoned and asked to answer a questionnaire.
Detailed description
Since October 1st 2015, our center has been labelled reference center for colorectal surgery using Enhanced Recovery Protocol (ERP) by GRACE (Groupe francophone de Rehabilitation après ChirurgiE; a francophone counterpart of ERAS® society). In case of ERP, the quality of life when the patient is at home is not well known. Some argue that patient might experience discomfort and lack of autonomy, particularly elderly patient if discharged home too quickly.
In this study, the investigators will call our patients introduced in the database of GRACE to assess the quality of life and patient satisfaction concerning our ERP. Eight domains will be investigated: information, stress, feelings when discharged home, pain, fatigue, autonomy, feeding problems, and satisfaction.
When analyzing the results the investigators will pay a particular attention to elderly patients (age > 70 yo) to determine whether these experience more difficulties as compared to younger patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients included in our GRACE database since the 1st of October 2015
Key inclusion criteria (1 listed)
- all patients included in our GRACE database
Key exclusion criteria (1 listed)
- No 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.
Primary outcome
Quality of life (0 to ten numeric scale + questionnaire)
Time frame: first month after leaving the hospital
0 to ten numeric scale + questionnaire
3 secondary outcomes
Satisfaction (0 to ten numeric scale + questionnaire)
Time frame: first month after leaving the hospital
Pain (0 to ten numeric scale + questionnaire)
Time frame: first month after leaving the hospital
Fatigue (0 to ten numeric scale + questionnaire)
Time frame: first month after leaving the hospital
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 3 Jan 2018.
- Individual participant dataSharing planned: No
Related trials for Surgery
RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Recruiting
Change in Platelet Lipid Metabolism and Procoagulant Phenotype Induced by Cardiopulmonary Bypass. Impact on Postoperative Inflammatory Response and Bleeding Complications During Cardiac Surgery.
Cardiac Surgery, Cardiopulmonary Bypass
RecruitingPhase 2
Evaluating Intranasal Oxytocin (TNX-1900) for Pain Relief and Recovery After Pituitary Surgery
Pain, Pituitary Surgery
Not yet recruiting
Feasibility Study of a Conversational Chatbot for Outpatient Postoperative Follow-up in Otorhinolaryngology (ENT): Acceptability, Patterns of Use, and Patient Experience.
Surgery Ambulatory, ENT Surgery
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.
Jean Joris, M.D. principal investigator
Department of Anesthesiology, CHU Liege, Belgium
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 Surgery, run by University of Liege at 1 site in Belgium.
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 3 Jan 2018. 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 Belgium. 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?
Quality of life (0 to ten numeric scale + questionnaire) (time frame: first month after leaving the hospital). 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 3 Jan 2018; AzTrials last refreshed its copy on 7 Nov 2026.