Colorectal SurgeryNCT04739605
Quality of Recovery Using QoR-15 in Enhanced Recovery After Colorectal Surgery.
An observational study of Colorectal Surgery and Patient-related Outcomes Measures, run by University of Liege at 1 site in Belgium.
Trial summary
This observational study will evaluate the patient reported outcomes and postoperative patient-related quality of recovery in 150 patients undergoing colorectal surgery within an enhanced recovery program at CHU Liège. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Surgery, Patient-related Outcomes Measures, Enhanced Recovery After Surgery
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Apr 2021to 1 May 2022
- How long will I take part?
- 2 Weeks
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Any patient schedules for colorectal surgery with the ERP at CHU Liège (Belgium). Patients age must be greater than 18 years. There is no maximum limit of age.
Who may be able to join
- •any patient scheduled for colorectal surgery within an ERP at CHU Liège
- Correct comprehension of french
Who cannot join
- •unable to answer the survey (cognitive disorders, bad knowledge of the French language)
- •closure of loop ileostomy
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
CHU de Liege
Liège, Liege, 4000
Jean Francois Brichant, MD, PhD, 0032 43667180, jfbrichant@chuliege.be
Pierre-Yves Hardy, MD, 003243667180, pyhardy@chuliege.be
About this study
Official title: Postoperative Patient-reported Quality of Recovery in Colorectal Surgery Patients Under Enhanced Recovery After Surgery Program Using QoR-15.
This observational study will evaluate the patient reported outcomes and postoperative patient-related quality of recovery in 150 patients undergoing colorectal surgery within an enhanced recovery program at CHU Liège. The QoR15 survey will be performed preoperatively and repeated postoperatively at hospital or via telephone calls on Day + 1, Day +2; Day + 3, Day 7 and Day + 14. The total score and the score at the subsections will be correlated with the medical and surgical characteristics of the patients.
Read the detailed description
For several years, we have been applying the concept of Enhanced Recovery Program (ERP) for colorectal surgery at CHU Liége (Belgium). Since October 2015, the University Hospital of Liège has been labelled as reference center for ERP after colorectal surgery by a French-speaking organization GRACE (French-speaking group for Enhanced Recovery after Surgery; www.grace-asso.fr). Despite the benefits for the patient and the economic benefits of such programs, few studies have investigated postoperative patient-related quality of recovery of patients who have had ERP.
This observational study will evaluate the patient reported outcomes and postoperative patient-related quality of recovery in 150 patients undergoing colorectal surgery according to an ERP at CHU Liège.The QoR15 survey will be performed preoperatively and repeated postoperatively at hospital or via telephone calls on Day + 1, Day +2; Day + 3, Day 7 and Day + 14. The total score and the answers at the subsections will be correlated with the medical and surgical characteristics of the patients.
- Keywords
- colorectal, enhanced recovery, patient-related outcomes measures, QoR15
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of Quality of recovery-15 (QoR-15) score between the preoperative scopre at Day 0 and postoperative score at Day 1 and its link between length of stay and occurrence of complication.
The score of the Quality of recovery-15 (QoR-15) Survey and subscores. The 11-point numerical rating scale leads to a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start1 Apr 2021
- Primary completion1 Apr 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 2 Weeks
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-François Brichant, PhD, Principal investigator, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04739605
- Sponsor's protocol ID
- 2021-colorectal-QoR15
- Status last verified
- Jun 2021
- First submitted
- 3 Feb 2021
- Last updated
- 23 Jun 2021
- 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 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Patient-reported Quality of Recovery in Colorectal Surgery Patients Under Enhanced Recovery After Surgery Program Using QoR-15.
- ClinicalTrials.gov ID
- NCT04739605
- Acronym / sponsor ID
- 2021-colorectal-QoR15
- Keywords
- colorectal, enhanced recovery, patient-related outcomes measures, QoR15
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 4 Feb 2021 (actual)
- 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.
This observational study will evaluate the patient reported outcomes and postoperative patient-related quality of recovery in 150 patients undergoing colorectal surgery within an enhanced recovery program at CHU Liège. The QoR15 survey will be performed preoperatively and repeated postoperatively at hospital or via telephone calls on Day + 1, Day +2; Day + 3, Day 7 and Day + 14. The total score and the score at the subsections will be correlated with the medical and surgical characteristics of the patients.
Detailed description
For several years, we have been applying the concept of Enhanced Recovery Program (ERP) for colorectal surgery at CHU Liége (Belgium). Since October 2015, the University Hospital of Liège has been labelled as reference center for ERP after colorectal surgery by a French-speaking organization GRACE (French-speaking group for Enhanced Recovery after Surgery; www.grace-asso.fr). Despite the benefits for the patient and the economic benefits of such programs, few studies have investigated postoperative patient-related quality of recovery of patients who have had ERP.
This observational study will evaluate the patient reported outcomes and postoperative patient-related quality of recovery in 150 patients undergoing colorectal surgery according to an ERP at CHU Liège.The QoR15 survey will be performed preoperatively and repeated postoperatively at hospital or via telephone calls on Day + 1, Day +2; Day + 3, Day 7 and Day + 14. The total score and the answers at the subsections will be correlated with the medical and surgical characteristics of the patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient schedules for colorectal surgery with the ERP at CHU Liège (Belgium). Patients age must be greater than 18 years. There is no maximum limit of age.
Key inclusion criteria (2 listed)
- •any patient scheduled for colorectal surgery within an ERP at CHU Liège
- Correct comprehension of french
Key exclusion criteria (2 listed)
- •unable to answer the survey (cognitive disorders, bad knowledge of the French language)
- •closure of loop ileostomy
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
Difference of Quality of recovery-15 (QoR-15) score between the preoperative scopre at Day 0 and postoperative score at Day 1 and its link between length of stay and occurrence of complication.
Time frame: 2 weeks
The score of the Quality of recovery-15 (QoR-15) Survey and subscores. The 11-point numerical rating scale leads to a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- 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.
Jean-François Brichant, PhD principal investigator
Centre Hospitalier Universitaire de Liege
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 Colorectal Surgery and Patient-related Outcomes Measures, 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Jun 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre-Yves Hardy, MD (00 32-4-3667180, pyhardy@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of Quality of recovery-15 (QoR-15) score between the preoperative scopre at Day 0 and postoperative score at Day 1 and its link between length of stay and occurrence of complication. (time frame: 2 weeks). 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 23 Jun 2021.