Clinical trial · Interventional
Incidence of Acute Urine Retention: Randomized Clinical Trial Comparing Early, Mid or Late Urinary Catheter Removal in Patients With Rectal Resection
Acute Urinary Retention After Early, Medium or Late Removal of the Urinary Catheter in Rectal Cancer Surgery. RAOREC Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
DESIGN: Randomized, open-label and parallel clinical trial, assigned to early, mid, or late withdrawal of urinary catheter with a 1: 1: 1 allocation ratio. POPULATION: Patients undergoing anterior rectal resection, low rectal resection, or abdominoperineal amputation for any reason. OBJECTIVES: The main objective is to compare the incidence of acute urine retention after removal of the urinary catheter in the postoperative period of rectal resection. Secondary objectives are: 1. Incidence of urinary tract infection after urinary catheter removal. 2. Incidence of specific postoperative complications (Surgical wound infection, Respiratory infection, Anastomotic dehiscence, ileus). 3. Incidence of postoperative complications assessed according to the Comprehensive Complication Index (CCI) scale. DESCRIPTION OF THE INTERVENTION: In all patients, a Rectal Resection (anterior rectal resection, posterior pelvic exenteration or abdominoperineal amputation) will be performed. In group 1A, the urinary catheter will be removed on the 1st postoperative day. In group 1B patients, the urinary catheter will be removed on the 3rd postoperative day. In group 1C patients, the urinary catheter will be removed on the 5th postoperative day. All patients will have a urine culture taken at the time of withdrawal.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anastomotic Leak | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Retention, Urinary | — | UNRESOLVED | — |
| Surgical Site Infection | — | UNRESOLVED | — |
| Urinary Tract Infections | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Removal of Urinary Catheter | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Early Urinary Catheter Removal
- description
- Urinary Catheter will be removed the first postoperative day after rectal resection
- interventionNames
- Procedure: Removal of Urinary Catheter
- type
- EXPERIMENTAL
- label
- Medium Urinary Catheter Removal
- description
- Urinary Catheter will be removed the third postoperative day after rectal resection
- interventionNames
- Procedure: Removal of Urinary Catheter
- type
- EXPERIMENTAL
- label
- Late Urinary Catheter Removal
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Patients undergoing programmed rectal surgery. * Age ≥ 18 years and \<85 years. * Any type of tumor, any T, N, M. * Consent signed by the patient and the researcher. Exclusion Criteria: * IPSS\> 20 * Transanal local resection. * Urinary catheterization in the 7 days prior to surgery. * Patients taking treatment for benign prostatic hyperplasia. * Urine infection in the month prior to surgery. * Patients with chronic kidney failure with Creatinine\> 2 mg / dL. * Enterovesical fistula. * Neurogenic bladder. * Patients with a sacral nerve stimulator or artificial sphincter. * Inability to read or understand any of the languages of informed consent. * Emergency surgery. * Psychiatric illnesses, addictions or any disorder that prevents the understanding of informed consent.
References
Publications (7)
- BACKGROUNDBarone JG, Cummings KB. Etiology of acute urinary retention following benign anorectal surgery. Am Surg. 1994 Mar;60(3):210-1. PMID 8116984
- BACKGROUNDSartori CA, Sartori A, Vigna S, Occhipinti R, Baiocchi GL. Urinary and sexual disorders after laparoscopic TME for rectal cancer in males. J Gastrointest Surg. 2011 Apr;15(4):637-43. doi: 10.1007/s11605-011-1459-0. Epub 2011 Feb 17. PMID 21327977
- BACKGROUNDKeating JP. Sexual function after rectal excision. ANZ J Surg. 2004 Apr;74(4):248-59. doi: 10.1111/j.1445-2197.2004.02954.x. PMID 15043737
- BACKGROUNDGeorge D, Pramil K, Kamalesh NP, Ponnambatheyil S, Kurumboor P. Sexual and urinary dysfunction following laparoscopic total mesorectal excision in male patients: A prospective study. J Minim Access Surg. 2018 Apr-Jun;14(2):111-117. doi: 10.4103/jmas.JMAS_93_17. PMID 28928335
- BACKGROUNDZmora O, Madbouly K, Tulchinsky H, Hussein A, Khaikin M. Urinary bladder catheter drainage following pelvic surgery--is it necessary for that long? Dis Colon Rectum. 2010 Mar;53(3):321-6. doi: 10.1007/DCR.06013e3181c7525c. PMID 20173480
- BACKGROUNDPatel DN, Felder SI, Luu M, Daskivich TJ, N Zaghiyan K, Fleshner P. Early Urinary Catheter Removal Following Pelvic Colorectal Surgery: A Prospective, Randomized, Noninferiority Trial. Dis Colon Rectum. 2018 Oct;61(10):1180-1186. doi: 10.1097/DCR.0000000000001206. PMID 30192326
- RESULTPetros JG, Bradley TM. Factors influencing postoperative urinary retention in patients undergoing surgery for benign anorectal disease. Am J Surg. 1990 Apr;159(4):374-6. doi: 10.1016/s0002-9610(05)81274-7. PMID 2316800