Surgical ComplicationNCT05249192
Immediate Versus Early (24-hours) Urinary Catheter Removal After Elective Minimally Invasive Colonic Resection
A study testing Immediate urinary catheter removal and Early urinary catheter removal in people with Surgical Complication and Colonic Disease, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
Trial summary
The primary aim of this study is to compare the rate of acute urinary retention (AUR) after immediate compared to early (24-hours) removal of urinary catheter (UC) in patients undergoing minimally invasive colorectal resection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Surgical Complication, Colonic Disease, Postoperative Complications
- What is being tested?
- Immediate urinary catheter removal and Early urinary catheter removal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteItaly
- Study dates
- 15 Feb 2022to 26 Nov 2024
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 years and 80 years old
- Patients scheduled to undergo minimally invasive resection of the colon under general anesthesia
- Willingness to participate
- Compliance to study purpose
- Written informed consent
Who cannot join
- Need for an anastomosis below the anterior peritoneal reflection
- Need for a major resection other than colorectal
- Need for post-operative intensive care monitoring or intensive care unit (ICU) stay
- Anesthesia time longer than 300 minutes
- Presence of chronic indwelling UC
- Presence of an entero-vesical fistula
- Need for ureteral stent placement, bladder resection or repair
- A previous and unsolved history of AUR or overt voiding dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Versus Early (24-hours) Urinary Catheter Removal After Elective Minimally Invasive Colonic Resection: Study Protocol for a Randomized, Multicenter, Non-inferiority Trial
The primary aim of this study is to compare the rate of acute urinary retention (AUR) after immediate compared to early (24-hours) removal of urinary catheter (UC) in patients undergoing minimally invasive colorectal resection. The study hypothesis is that immediate UC removal is non-inferior to 24-hours UC removal in terms of AUR rate.
The secondary outcomes focus on goals that could be positively impacted by the immediate removal of the UC at the end of the surgery. In particular, the rate of urinary tract infections, perception of pain, time-to-return of bowel and physical functions, postoperative complications and postoperative length of stay will all be measured.
- Conditions
- Surgical Complication, Colonic Disease, Postoperative Complications, Urinary Retention Postoperative, Urinary Tract Infections
- Being tested
- Immediate urinary catheter removal, Early urinary catheter removal
- Medical subject headings
- Colonic Diseases, Postoperative Complications, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate urinary catheter removalDevice
Urinary catheter removal immediately after the end of the surgical procedure before exiting the operating room.
Early urinary catheter removalDevice
urinary catheter removal on the first postoperative day (6 a.m)
| Study group | Role | What they receive |
|---|---|---|
| Immediate UC removal | Experimental | Urinary catheter removal immediately after the end of the surgical procedure before exiting the operating room. Receives: Device: Immediate urinary catheter removal |
| Early UC removal | Active comparator | Urinary catheter removal on first postoperative day (6 a.m.) as per standard protocol Receives: Device: Early urinary catheter removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute urinary retention rate
Occurrence of urinary retention after removal of urinary catheter
Measured: 3 days postoperatively
Secondary outcomes (7)
Urinary tract infections
Occurrence of urinary tract infections
Measured: 30 days postoperatively
UC reinsertion
need for urinary catheter reinsertion after first removal
Measured: 30 days postoperatively
Pain scores
Numeric Rating Scores (NRS) for abdominal pain (0-10)
Measured: 6,12,24,48 and 72 hours after surgery
Bowel function
Time for return of bowel function as for flatus and stools postoperatively
Measured: 10 days postoperatively
Mobilization
Return to passive and active mobilization postoperatively
Measured: 10 days postoperatively
Morbility
Postoperative morbility according to the Clavien-Dindo classification
Measured: first 30 days after surgery
Length of hospital stay
postoperative stay
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start15 Feb 2022
- Primary completion1 Jul 2024
- Study completion26 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical ComplicationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized, controlled, two-arm, multi-center trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Collaborators
- Faenza Hospital, Ravenna Hospital, Humanitas Research Hospital IRCCS, Rozzano-Milan, Humanitas University, Universita di Verona
- Responsible party
- Sponsor
- Investigators
- Corrado Pedrazzani, Professor, Principal investigator, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249192
- Sponsor's protocol ID
- EURiCaRe
- Status last verified
- Nov 2024
- First submitted
- 9 Feb 2022
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pedrazzani C, Montroni I, Conti C, Turri G, Foppa C, Carvello M, Taffurelli G, Ugolini G, Spinelli A. Immediate versus early (24-hours) urinary catheter removal after elective minimally invasive colonic resection: study protocol for a randomized, multicenter, non-inferiority trial. Trials. 2022 Nov 22;23(1):956. doi: 10.1186/s13063-022-06894-6.
PubMed 36414969
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Versus Early (24-hours) Urinary Catheter Removal After Elective Minimally Invasive Colonic Resection: Study Protocol for a Randomized, Multicenter, Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT05249192
- Acronym / sponsor ID
- EURiCaRe
- Conditions
- Surgical Complication, Colonic Disease, Postoperative Complications, Urinary Retention Postoperative, Urinary Tract Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Collaborators
- Faenza Hospital, Ravenna Hospital, Humanitas Research Hospital IRCCS, Rozzano-Milan, Humanitas University, Universita di Verona
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 26 Nov 2024 (actual)
- First posted
- 21 Feb 2022 (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.
The primary aim of this study is to compare the rate of acute urinary retention (AUR) after immediate compared to early (24-hours) removal of urinary catheter (UC) in patients undergoing minimally invasive colorectal resection. The study hypothesis is that immediate UC removal is non-inferior to 24-hours UC removal in terms of AUR rate.
The secondary outcomes focus on goals that could be positively impacted by the immediate removal of the UC at the end of the surgery. In particular, the rate of urinary tract infections, perception of pain, time-to-return of bowel and physical functions, postoperative complications and postoperative length of stay will all be measured.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- prospective, randomized, controlled, two-arm, multi-center trial
| Arm | Type | Receives |
|---|---|---|
| Immediate UC removal | Experimental | Device: Immediate urinary catheter removalUrinary catheter removal immediately after the end of the surgical procedure before exiting the operating room. |
| Early UC removal | Active comparator | Device: Early urinary catheter removalUrinary catheter removal on first postoperative day (6 a.m.) as per standard protocol |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 years and 80 years old
- Patients scheduled to undergo minimally invasive resection of the colon under general anesthesia
- Willingness to participate
- Compliance to study purpose
- Written informed consent
Key exclusion criteria (8 listed)
- Need for an anastomosis below the anterior peritoneal reflection
- Need for a major resection other than colorectal
- Need for post-operative intensive care monitoring or intensive care unit (ICU) stay
- Anesthesia time longer than 300 minutes
- Presence of chronic indwelling UC
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 |
|---|---|---|
| Immediate urinary catheter removalUrinary catheter removal immediately after the end of the surgical procedure before exiting the operating room. | Device | Immediate UC removal |
| Early urinary catheter removalurinary catheter removal on the first postoperative day (6 a.m) | Device | Early UC removal |
Primary outcome
Acute urinary retention rate
Time frame: 3 days postoperatively
Occurrence of urinary retention after removal of urinary catheter
7 secondary outcomes
Urinary tract infections
Time frame: 30 days postoperatively
UC reinsertion
Time frame: 30 days postoperatively
Pain scores
Time frame: 6,12,24,48 and 72 hours after surgery
Bowel function
Time frame: 10 days postoperatively
Mobilization
Time frame: 10 days postoperatively
Morbility
Time frame: first 30 days after surgery
Length of hospital stay
Time frame: 30 days postoperatively
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 29 Nov 2024.
- Derived from this study: PubMed 36414969Pedrazzani C, Montroni I, Conti C, Turri G, Foppa C, Carvello M, Taffurelli G, Ugolini G, Spinelli A. Immediate versus early (24-hours) urinary catheter removal after elective minimally invasive colonic resection: study protocol for a randomized, multicenter, non-inferiority trial. Trials. 2022 Nov 22;23(1):956. doi: 10.1186/s13063-022-06894-6.
- 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.
Corrado Pedrazzani, Professor principal investigator
Universita di Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate urinary catheter removal and Early urinary catheter removal in people with Surgical Complication and Colonic Disease, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
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 5 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 29 Nov 2024. 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 Italy. 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?
Acute urinary retention rate (time frame: 3 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05249192, which also lists 1 linked publication.
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 29 Nov 2024.