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Incidence of Acute Urine Retention: Randomized Clinical Trial Comparing Early, Mid or Late Urinary Catheter Removal in Patients With Rectal Resection (RAOREC)

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ClinicalTrials.gov Identifier: NCT04751149
Recruitment Status : Recruiting
First Posted : February 11, 2021
Last Update Posted : February 11, 2021
Sponsor:
Information provided by (Responsible Party):
Prof. Jose M Enríquez-Navascués, Hospital Donostia

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Rectal Cancer Retention, Urinary Urinary Tract Infections Surgical Site Infection Anastomotic Leak Procedure: Removal of Urinary Catheter Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Early removal of urinary catheter Medial removal of urinary catheter Late removal of urinary catheter
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Acute Urinary Retention After Early, Medium or Late Removal of the Urinary Catheter in Rectal Cancer Surgery. RAOREC Study
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Early Urinary Catheter Removal
Urinary Catheter will be removed the first postoperative day after rectal resection
Procedure: Removal of Urinary Catheter
Urinary catheter will be removed in aeseptic conditions. Before the removal a urinary culture will be obtained from the catheter.

Experimental: Medium Urinary Catheter Removal
Urinary Catheter will be removed the third postoperative day after rectal resection
Procedure: Removal of Urinary Catheter
Urinary catheter will be removed in aeseptic conditions. Before the removal a urinary culture will be obtained from the catheter.

Experimental: Late Urinary Catheter Removal
Urinary Catheter will be removed the fifth postoperative day after rectal resection
Procedure: Removal of Urinary Catheter
Urinary catheter will be removed in aeseptic conditions. Before the removal a urinary culture will be obtained from the catheter.




Primary Outcome Measures :
  1. to compare the incidence of acute urine retention after removal of the urinary catheter in the postoperative period of rectal resection. [ Time Frame: 1-30 days ]
    to compare the incidence of acute urine retention after removal of the urinary catheter in the postoperative period of rectal resection, measured by the proportion of patients that need to be newly catheterized in the first 30 postoperative days.


Secondary Outcome Measures :
  1. Incidence of urinary tract infection after urinary catheter removal. [ Time Frame: 1-30 days ]
    Proportion of patients that hace a urinary tract infection measured by the culture obtained at the time of the removal of the catheter.

  2. Incidence of surgical wound infection [ Time Frame: 1-30 days ]
    Incidence of surgical wound infection after rectal resection surgery measured by a positive culture or a drained abscess.

  3. Incidence of respiratory infection [ Time Frame: 1-30 days ]
    Respiratory infection is considered a positive sputum culture and / or a chest radiograph with parenchymal condensations.

  4. Incidence of anastomotic dehiscence [ Time Frame: 1-30 days ]
    The incidence of anastomotic dehiscence and its severity is measured by the International Study Group of Rectal Cancer. Anastomotic dehiscence is defined as a defect of the intestinal wall at the anastomotic site (including suture and staple lines of neorectal reservoirs) leading to a communication between the intra- and extraluminal compartments

  5. Incidence of ileus [ Time Frame: 1-30 days ]
    Incidence of ileus measured by the proportion of patients with delay in oral tolerance due to vomiting, abdominal distension, or the need for nasogastric tube placement.

  6. Incidence of postoperative complications [ Time Frame: 1-30 days ]
    Postoperative complications according to the Comprehensive Complication Index (CCI) scale. The CCI integrates all complications of the Clavien-Dindo classification and offers a metric approach to measure morbidity. Higher rates mean more complications.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04751149


Contacts
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Contact: Garazi Elorza, MD +34 619939947 garazielorza@gmail.com

Locations
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Spain
Hospital Donostia Recruiting
Donostia, Guipuzcos, Spain, 20014
Contact: Garazi Elorza, MD    34 619939947    garazielorza@gmail.com   
Sponsors and Collaborators
Hospital Donostia
Investigators
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Principal Investigator: Jose Maria Enriquez-Navascues, PhD H Donostia
Publications of Results:
Other Publications:
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Responsible Party: Prof. Jose M Enríquez-Navascués, PhD; Head of service, Hospital Donostia
ClinicalTrials.gov Identifier: NCT04751149    
Other Study ID Numbers: ELO-RAO-2019-01
First Posted: February 11, 2021    Key Record Dates
Last Update Posted: February 11, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Surgical Wound Infection
Rectal Neoplasms
Urinary Retention
Anastomotic Leak
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Urologic Diseases
Wound Infection
Postoperative Complications
Pathologic Processes
Urination Disorders