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| Name | Class |
|---|---|
| Faenza Hospital | UNKNOWN |
| Ravenna Hospital | UNKNOWN |
| Humanitas Research Hospital IRCCS, Rozzano-Milan | OTHER |
| Humanitas University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate UC removal | Experimental | Urinary catheter removal immediately after the end of the surgical procedure before exiting the operating room. |
|
| Early UC removal | Active Comparator | Urinary catheter removal on first postoperative day (6 a.m.) as per standard protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate urinary catheter removal | Device | Urinary catheter removal immediately after the end of the surgical procedure before exiting the operating room. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute urinary retention rate | Occurrence of urinary retention after removal of urinary catheter | 3 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary tract infections | Occurrence of urinary tract infections | 30 days postoperatively |
| UC reinsertion | need for urinary catheter reinsertion after first removal |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Corrado Pedrazzani, Professor | Universita di Verona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of General and Hepatobiliary Surgery | Verona | Italy | 37134 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36414969 | Derived | 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. |
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| OTHER |
| Universita di Verona | OTHER |
prospective, randomized, controlled, two-arm, multi-center trial
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patients and surgeons are blinded to group allocation until the end of surgical procedure
| Early urinary catheter removal | Device | urinary catheter removal on the first postoperative day (6 a.m) |
|
| 30 days postoperatively |
| Pain scores | Numeric Rating Scores (NRS) for abdominal pain (0-10) | 6,12,24,48 and 72 hours after surgery |
| Bowel function | Time for return of bowel function as for flatus and stools postoperatively | 10 days postoperatively |
| Mobilization | Return to passive and active mobilization postoperatively | 10 days postoperatively |
| Morbility | Postoperative morbility according to the Clavien-Dindo classification | first 30 days after surgery |
| Length of hospital stay | postoperative stay | 30 days postoperatively |
| ID | Term |
|---|---|
| D003108 | Colonic Diseases |
| D011183 | Postoperative Complications |
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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