Immediate versus early (24-hours) urinary catheter removal after elective minimally invasive colonic resection: study protocol for a randomized, multicenter, non-inferiority trial
Abstract Background Enhanced Recovery After Surgery (ERAS) represents the standard of care in colorectal surgery. Among ERAS items, early removal of urinary catheter (UC) is considered a key issue, though adherence to this specific item still varies among centers. UC placement allows for monitoring...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2022-11-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-022-06894-6 |
| _version_ | 1811186898698240000 |
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| author | Corrado Pedrazzani Isacco Montroni Cristian Conti Giulia Turri Caterina Foppa Michele Carvello Giovanni Taffurelli Giampaolo Ugolini Antonino Spinelli |
| author_facet | Corrado Pedrazzani Isacco Montroni Cristian Conti Giulia Turri Caterina Foppa Michele Carvello Giovanni Taffurelli Giampaolo Ugolini Antonino Spinelli |
| author_sort | Corrado Pedrazzani |
| collection | DOAJ |
| description | Abstract Background Enhanced Recovery After Surgery (ERAS) represents the standard of care in colorectal surgery. Among ERAS items, early removal of urinary catheter (UC) is considered a key issue, though adherence to this specific item still varies among centers. UC placement allows for monitoring of post-operative urinary output but relates to an increased risk of urinary tract infection (UTI), reduced mobility, and patient’s discomfort. Several studies investigated the role of early UC removal specifically looking at the rate of acute urinary retention (AUR) but most of them were retrospective, single-center, underpowered, cohort studies. The main purpose of this study is to compare the rate of AUR after immediate (at the end of the surgery) versus early (within 24 h from the completion of surgery) removal of UC in patients undergoing minimally invasive colonic resection (MICR). 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 UTIs, perception of pain, time-to-return of bowel and physical functions, postoperative complications, and length of hospital stay will be measured. Methods This is a prospective, randomized, controlled, two-arm, multi-center, study comparing the rate of AUR after immediate versus early removal of UC in patients undergoing MICR. The investigators hypothesize that immediate UC removal is non-inferior to 24-h UC removal in terms of AUR rate. Randomization is at the patient level and participants are randomized 1:1 to remove their UC either immediately or within 24 h from the completion of surgery. Those eligible for inclusion were patients undergoing any MICR with an anastomosis above the peritoneal reflection. Those patients who need to continue urinary output monitoring after the surgery will be excluded. The number of patients calculated to be enrolled in each group is 108 based on an expected AUR rate of 3% for the 24-h UC removal group and considering acceptable an AUR of 9% for the immediate UC removal group. Discussion The demonstration of a non-inferiority of immediate versus 24-h removal of UC would call into question the usefulness of urinary drainage in the setting of MICR. Trial registration ClinicalTrials.gov NCT05249192. Prospectively registered on February 21, 2022. |
| first_indexed | 2024-04-11T13:54:03Z |
| format | Article |
| id | doaj.art-ab47da6024dc4e818ff539259aa4a2b5 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-11T13:54:03Z |
| publishDate | 2022-11-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-ab47da6024dc4e818ff539259aa4a2b52022-12-22T04:20:27ZengBMCTrials1745-62152022-11-012311810.1186/s13063-022-06894-6Immediate versus early (24-hours) urinary catheter removal after elective minimally invasive colonic resection: study protocol for a randomized, multicenter, non-inferiority trialCorrado Pedrazzani0Isacco Montroni1Cristian Conti2Giulia Turri3Caterina Foppa4Michele Carvello5Giovanni Taffurelli6Giampaolo Ugolini7Antonino Spinelli8Division of General and Hepatobiliary Surgery, Department of Surgical Sciences, Dentistry, Gynecology and Pediatrics, University of VeronaDivision of Colon and Rectal Surgery, Faenza HospitalDivision of General and Hepatobiliary Surgery, Department of Surgical Sciences, Dentistry, Gynecology and Pediatrics, University of VeronaDivision of General and Hepatobiliary Surgery, Department of Surgical Sciences, Dentistry, Gynecology and Pediatrics, University of VeronaDivision of Colon and Rectal Surgery, IRCCS Humanitas Research HospitalDivision of Colon and Rectal Surgery, IRCCS Humanitas Research HospitalDivision of Colon and Rectal Surgery, Faenza HospitalDivision of Colon and Rectal Surgery, Faenza HospitalDivision of Colon and Rectal Surgery, IRCCS Humanitas Research HospitalAbstract Background Enhanced Recovery After Surgery (ERAS) represents the standard of care in colorectal surgery. Among ERAS items, early removal of urinary catheter (UC) is considered a key issue, though adherence to this specific item still varies among centers. UC placement allows for monitoring of post-operative urinary output but relates to an increased risk of urinary tract infection (UTI), reduced mobility, and patient’s discomfort. Several studies investigated the role of early UC removal specifically looking at the rate of acute urinary retention (AUR) but most of them were retrospective, single-center, underpowered, cohort studies. The main purpose of this study is to compare the rate of AUR after immediate (at the end of the surgery) versus early (within 24 h from the completion of surgery) removal of UC in patients undergoing minimally invasive colonic resection (MICR). 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 UTIs, perception of pain, time-to-return of bowel and physical functions, postoperative complications, and length of hospital stay will be measured. Methods This is a prospective, randomized, controlled, two-arm, multi-center, study comparing the rate of AUR after immediate versus early removal of UC in patients undergoing MICR. The investigators hypothesize that immediate UC removal is non-inferior to 24-h UC removal in terms of AUR rate. Randomization is at the patient level and participants are randomized 1:1 to remove their UC either immediately or within 24 h from the completion of surgery. Those eligible for inclusion were patients undergoing any MICR with an anastomosis above the peritoneal reflection. Those patients who need to continue urinary output monitoring after the surgery will be excluded. The number of patients calculated to be enrolled in each group is 108 based on an expected AUR rate of 3% for the 24-h UC removal group and considering acceptable an AUR of 9% for the immediate UC removal group. Discussion The demonstration of a non-inferiority of immediate versus 24-h removal of UC would call into question the usefulness of urinary drainage in the setting of MICR. Trial registration ClinicalTrials.gov NCT05249192. Prospectively registered on February 21, 2022.https://doi.org/10.1186/s13063-022-06894-6Colorectal surgeryLaparoscopyERASUrinary catheter |
| spellingShingle | Corrado Pedrazzani Isacco Montroni Cristian Conti Giulia Turri Caterina Foppa Michele Carvello Giovanni Taffurelli Giampaolo Ugolini Antonino Spinelli Immediate versus early (24-hours) urinary catheter removal after elective minimally invasive colonic resection: study protocol for a randomized, multicenter, non-inferiority trial Trials Colorectal surgery Laparoscopy ERAS Urinary catheter |
| title | Immediate versus early (24-hours) urinary catheter removal after elective minimally invasive colonic resection: study protocol for a randomized, multicenter, non-inferiority trial |
| title_full | Immediate versus early (24-hours) urinary catheter removal after elective minimally invasive colonic resection: study protocol for a randomized, multicenter, non-inferiority trial |
| title_fullStr | Immediate versus early (24-hours) urinary catheter removal after elective minimally invasive colonic resection: study protocol for a randomized, multicenter, non-inferiority trial |
| title_full_unstemmed | Immediate versus early (24-hours) urinary catheter removal after elective minimally invasive colonic resection: study protocol for a randomized, multicenter, non-inferiority trial |
| title_short | Immediate versus early (24-hours) urinary catheter removal after elective minimally invasive colonic resection: study protocol for a randomized, multicenter, non-inferiority trial |
| title_sort | immediate versus early 24 hours urinary catheter removal after elective minimally invasive colonic resection study protocol for a randomized multicenter non inferiority trial |
| topic | Colorectal surgery Laparoscopy ERAS Urinary catheter |
| url | https://doi.org/10.1186/s13063-022-06894-6 |
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