NCT05020613

Brief Summary

It was aimed to investigate the need for urinary retention and recatheterization in the postoperative period by removing the urinary catheter in patients undergoing low anterior resection, in the early or late period.

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
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 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

July 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 25, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

6 months

First QC Date

August 19, 2021

Last Update Submit

August 19, 2021

Conditions

Colorectal SurgeryRectal CancerUrinary Retention Postoperative

Outcome Measures

Primary Outcomes (3)

  • Post-operative urinary retention requiring re-catheterisation

    Development of acute post-operative urinary retention requiring re-catheterisation within 1 day of removal of urethral catheter in the post-operative period.

    1 day

  • Postoperative urine culture

    Investigate any colonization before discharge in both groups

    7 days

  • Discharge with urinary catheter

    Any need for urinary catheter at the time of the discharge

    7 days

Study Arms (2)

Early group

OTHER

Patients whose catheters are removed within the first 48 hours after surgery will form the early group.

Procedure: Procedure: Early removal group

Late group

OTHER

Patients whose catheters are removed after the first 48 hours of surgery will form the early group.

Procedure: Procedure: Late removal group

Interventions

Procedure: Early removal groupPROCEDURE

Participants assigned this arm will have their urethral catheters removed at 2 days after low anterior resection of the rectum

Early group
Procedure: Late removal groupPROCEDURE

Participants assigned this arm will have their urethral catheters removed after 48.th hours after Low anterior resection of the rectum

Late group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who will undergo Low Anterior Resection due to rectal cancer in the Department of General Surgery of our university.
  • Competent to consent to participate in trial
  • Elective surgery
  • ASA classification of 1\~3

You may not qualify if:

  • Patients whose post-treatment status cannot be obtained.
  • Having Bladder surgery before
  • Having a previous prostate surgery.
  • Patient's refusal to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara university Pendik Research and Education Hospital

Istanbul, 3846, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Duchalais E, Larson DW, Machairas N, Mathis KL, Dozois EJ, Kelley SR. Outcomes of Early Removal of Urinary Catheter Following Rectal Resection for Cancer. Ann Surg Oncol. 2019 Jan;26(1):79-85. doi: 10.1245/s10434-018-6822-x. Epub 2018 Oct 23.

    PMID: 30353391BACKGROUND

  • Xu L, Tao ZY, Lu JY, Zhang GN, Qiu HZ, Wu B, Lin GL, Xu T, Xiao Y. A single-center, prospective, randomized clinical trial to investigate the optimal removal time of the urinary catheter after laparoscopic anterior resection of the rectum: study protocol for a randomized controlled trial. Trials. 2019 Feb 15;20(1):133. doi: 10.1186/s13063-019-3210-1.

    PMID: 30770766BACKGROUND

  • Yoo BE, Kye BH, Kim HJ, Kim G, Kim JG, Cho HM. Early Removal of the Urinary Catheter After Total or Tumor-Specific Mesorectal Excision for Rectal Cancer Is Safe. Dis Colon Rectum. 2015 Jul;58(7):686-91. doi: 10.1097/DCR.0000000000000386.

    PMID: 26200683BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Tevfik Uprak, MD

CONTACT

+905337273328kuprak@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 19, 2021

First Posted

August 25, 2021

Study Start

July 1, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

August 25, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)