Quality of RecoveryNCT04694950
Postoperative Recovery and Comfort in Patients Undergoing Urologic Robotic Surgery
An observational study of Quality of Recovery and Urology, run by Linkoeping University at 1 site in Sweden.
Trial summary
Previously published studies show that adding intrathecal morphine to general anesthesia can reduce the postoperative pain and length of stay (LOS) in varies types of surgery. A recent meta-analysis showed that the addition of intrathecal morphine at doses below 500µg did not increase the risk of respiratory… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Recovery, Urology, Pain
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 30 Dec 2020to 30 Nov 2021
- 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: Adult population undergoing elective urologic robotic assisted laparoscopic surgery in Linkoping University Hospital, sweden.
Who may be able to join
- Scheduled for elective urologic robotic assisted laparoscopic surgery in Linkoping University Hospital
Who cannot join
- Age <18
- Not expected to comprehend the written or verbal study information
- Patient planned for robotic assisted laparoscoic prostatectomy or robotic assisted laparoscopic cystectomy
- Acute surgery
- ASA class >3
- Major surgery on another organ planned at the same operation
- Patient planned for a neuraxial blockade in addition to general anaesthesia.
- Study personal not available
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Recovery and Comfort After Urologic Robotic Surgery: A Feasibility Study
Previously published studies show that adding intrathecal morphine to general anesthesia can reduce the postoperative pain and length of stay (LOS) in varies types of surgery. A recent meta-analysis showed that the addition of intrathecal morphine at doses below 500µg did not increase the risk of respiratory depression compared with a control group receiving intravenous opioids. Epidural analgesia is uncommonly used for robot-assisted laparoscopic procedures due to the limited surgical trauma. In addition, the risks associated with the epidural itself such as infection and spinal hematoma are thought to outweigh its possible benefits for these procedures.
At Linkoping University Hospital a combination of general anesthesia and intrathecal morphine in robot-assisted laparoscopic radical prostatectomy and in robotic-assisted laparoscopic cystectomy is now routinely used in order to improve postoperative recovery. However whether this approach is beneficial in other types of robotic-assisted urological procedures is unknown.
Read more
Therefore the investigators aim to conduct a feasibility study for the use of intrathecal morphine combined with general anaesthesia in adult patients undergoing elective urologic laparoscopic robot-assisted surgery at Linkoping University Hospital. The investigators will include 30 patients in the study. The specific aims are to investigate the feasibility and sensitivity of Quality of Recovery 15 (QoR15), as an outcome tool measuring postoperative well-being in this patient cohort.
The investigators will also investigate the feasibility of other outcome measures such as postoperative pain, post-anesthesia care unit LOS, occurrence of pruritus and hospital LOS.
For planning of the timeframe of the future interventional study the investigators will use this feasibility study to examine the inclusion rate of study patients.
- Conditions
- Quality of Recovery, Urology, Pain, PONV, Postoperative Complications, Laparoscopic
- Being tested
- Usual care
- Medical subject headings
- Pain, Postoperative Nausea and Vomiting, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careProcedure or surgery
Intravenous morphine according to clinician´s discretion.
| Study group | Role | What they receive |
|---|---|---|
| Group feasibility | Adults undergoing elective urologic laparoscopic robotic surgery. Receives: Procedure: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Recovery 15 (QoR-15) score
Quality of Recovery 15. A total of 15 questions each answered with a value from 0 to 10. The minimum value of the QoR-15 is 0 and the maximum value is 150. A higher value means a better outcome.
Measured: Preoperative, postoperative up to day 7
Secondary outcomes (5)
Postoperative pain
Measurement of pain in rest and in movement with the Numeric Rating Scale (NRS) Pain Scale. Minimum value is 0 (no pain) and maximum value is 10 (extreme pain).
Measured: Up to postoperative day 3
PONV
Measurement of the frequency of postoperative nausea and vomiting (PONV).
Measured: Up to postoperative day 3
Return of bowel function
Time to first passing of flatus and first passing of stool.
Measured: Up to postoperative day 7
Postoperative complications
Using the Clavien-Dindo Classification
Measured: Up to postoperative day 30
Length of hospital stay
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start30 Dec 2020
- Primary completion19 Oct 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of RecoveryStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Martin Holmberg, Linkoeping University
- Investigators
- Michelle Chew, MD PhD, Study director, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694950
- Sponsor's protocol ID
- 210101
- Status last verified
- Apr 2022
- First submitted
- 29 Dec 2020
- Last updated
- 6 Apr 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 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Recovery and Comfort After Urologic Robotic Surgery: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04694950
- Acronym / sponsor ID
- 210101
- Conditions
- Quality of Recovery, Urology, Pain, PONV, Postoperative Complications, Laparoscopic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 30 Dec 2020 (actual)
- Primary completion
- 19 Oct 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 5 Jan 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.
Previously published studies show that adding intrathecal morphine to general anesthesia can reduce the postoperative pain and length of stay (LOS) in varies types of surgery. A recent meta-analysis showed that the addition of intrathecal morphine at doses below 500µg did not increase the risk of respiratory depression compared with a control group receiving intravenous opioids. Epidural analgesia is uncommonly used for robot-assisted laparoscopic procedures due to the limited surgical trauma. In addition, the risks associated with the epidural itself such as infection and spinal hematoma are thought to outweigh its possible benefits for these procedures.
At Linkoping University Hospital a combination of general anesthesia and intrathecal morphine in robot-assisted laparoscopic radical prostatectomy and in robotic-assisted laparoscopic cystectomy is now routinely used in order to improve postoperative recovery. However whether this approach is beneficial in other types of robotic-assisted urological procedures is unknown.
Therefore the investigators aim to conduct a feasibility study for the use of intrathecal morphine combined with general anaesthesia in adult patients undergoing elective urologic laparoscopic robot-assisted surgery at Linkoping University Hospital. The investigators will include 30 patients in the study. The specific aims are to investigate the feasibility and sensitivity of Quality of Recovery 15 (QoR15), as an outcome tool measuring postoperative well-being in this patient cohort.
The investigators will also investigate the feasibility of other outcome measures such as postoperative pain, post-anesthesia care unit LOS, occurrence of pruritus and hospital LOS.
For planning of the timeframe of the future interventional study the investigators will use this feasibility study to examine the inclusion rate of study patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group feasibility | – | Procedure: Usual careAdults undergoing elective urologic laparoscopic robotic surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult population undergoing elective urologic robotic assisted laparoscopic surgery in Linkoping University Hospital, sweden.
Key inclusion criteria (1 listed)
- Scheduled for elective urologic robotic assisted laparoscopic surgery in Linkoping University Hospital
Key exclusion criteria (8 listed)
- Age <18
- Not expected to comprehend the written or verbal study information
- Patient planned for robotic assisted laparoscoic prostatectomy or robotic assisted laparoscopic cystectomy
- Acute surgery
- ASA class >3
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 |
|---|---|---|
| Usual careIntravenous morphine according to clinician´s discretion. | Procedure or surgery | Group feasibility |
Primary outcome
Change in Quality of Recovery 15 (QoR-15) score
Time frame: Preoperative, postoperative up to day 7
Quality of Recovery 15. A total of 15 questions each answered with a value from 0 to 10. The minimum value of the QoR-15 is 0 and the maximum value is 150. A higher value means a better outcome.
5 secondary outcomes
Postoperative pain
Time frame: Up to postoperative day 3
PONV
Time frame: Up to postoperative day 3
Return of bowel function
Time frame: Up to postoperative day 7
Postoperative complications
Time frame: Up to postoperative day 30
Length of hospital stay
Time frame: Up to 30 days
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 6 Apr 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.
Michelle Chew, MD PhD study director
Linkoeping University
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 Recovery and Urology, run by Linkoeping University at 1 site in Sweden.
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 8 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 6 Apr 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 Sweden. 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?
Change in Quality of Recovery 15 (QoR-15) score (time frame: Preoperative, postoperative up to day 7). 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 6 Apr 2022.