NCT04751149

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. 1.Incidence of urinary tract infection after urinary catheter removal.
  2. 2.Incidence of specific postoperative complications (Surgical wound infection, Respiratory infection, Anastomotic dehiscence, ileus).
  3. 3.Incidence of postoperative complications assessed according to the Comprehensive Complication Index (CCI) scale.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
143

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 27, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 11, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

February 11, 2021

Status Verified

February 1, 2021

Enrollment Period

3 years

First QC Date

October 27, 2020

Last Update Submit

February 9, 2021

Conditions

Rectal CancerRetention, UrinaryUrinary Tract InfectionsSurgical Site InfectionAnastomotic Leak

Outcome Measures

Primary Outcomes (1)

  • to compare the incidence of acute urine retention after removal of the urinary catheter in the postoperative period of rectal resection.

    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.

    1-30 days

Secondary Outcomes (6)

  • Incidence of urinary tract infection after urinary catheter removal.

    1-30 days

  • Incidence of surgical wound infection

    1-30 days

  • Incidence of respiratory infection

    1-30 days

  • Incidence of anastomotic dehiscence

    1-30 days

  • Incidence of ileus

    1-30 days

  • +1 more secondary outcomes

Study Arms (3)

Early Urinary Catheter Removal

EXPERIMENTAL

Urinary Catheter will be removed the first postoperative day after rectal resection

Procedure: Removal of Urinary Catheter

Medium Urinary Catheter Removal

EXPERIMENTAL

Urinary Catheter will be removed the third postoperative day after rectal resection

Procedure: Removal of Urinary Catheter

Late Urinary Catheter Removal

EXPERIMENTAL

Urinary Catheter will be removed the fifth postoperative day after rectal resection

Procedure: Removal of Urinary Catheter

Interventions

Removal of Urinary CatheterPROCEDURE

Urinary catheter will be removed in aeseptic conditions. Before the removal a urinary culture will be obtained from the catheter.

Early Urinary Catheter RemovalLate Urinary Catheter RemovalMedium Urinary Catheter Removal

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Donostia

Donostia / San Sebastian, Guipuzcos, 20014, Spain

RECRUITING

Related Publications (7)

  • Barone JG, Cummings KB. Etiology of acute urinary retention following benign anorectal surgery. Am Surg. 1994 Mar;60(3):210-1.

    PMID: 8116984BACKGROUND

  • Sartori 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: 21327977BACKGROUND

  • Keating 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: 15043737BACKGROUND

  • George 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: 28928335BACKGROUND

  • Zmora 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: 20173480BACKGROUND

  • Patel 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: 30192326BACKGROUND

  • Petros 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: 2316800RESULT

MeSH Terms

Conditions

Rectal NeoplasmsUrinary RetentionUrinary Tract InfectionsSurgical Wound InfectionAnastomotic Leak

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesInfectionsWound InfectionPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jose Maria Enriquez-Navascues, PhD

    H Donostia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Garazi Elorza, MD

CONTACT

+34 619939947garazielorza@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Early removal of urinary catheter Medial removal of urinary catheter Late removal of urinary catheter
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD; Head of service

Study Record Dates

First Submitted

October 27, 2020

First Posted

February 11, 2021

Study Start

May 1, 2019

Primary Completion

May 1, 2022

Study Completion

December 1, 2022

Last Updated

February 11, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)