A Study on Early Removal of Urinary Catheter After Gastric Cancer Surgery Applying ERAS Protocols

December 4, 2024 updated by: Affiliated Hospital of Nanjing University of Chinese Medicine
This study compared the immediate removal of urinary catheter and early removal of urinary catheter after radical gastrectomy to explore the feasibility of immediate removal of urinary catheter after radical gastrectomy, especially in the incidence of urinary retention, whether immediate removal is not inferior to early removal.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

181

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 025
        • Affiliated Hospital of Nanjing University of Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • underwent elective radical gastrectomy
  • applied ERAS protocols during perioperative period
  • aged 18～80 years old

Exclusion Criteria:

  • benign prostatic hyperplasia
  • urinary system stones, tumors, strictures, deformities or surgeries
  • pelvic surgery history
  • abnormal preoperative urine routine
  • medication intake that affects urination function

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: immediate removal of urinary catheter
The urinary catheter will be removed immediately after surgery.
Procedure: immediate urinary catheter removal
Immediate urinary catheter removal indicates that the urinary catheter will be removed immediately after surgery.
Other: early removal of urinary catheter
The urinary catheter will be kept after surgery and be removed within 48 hours after surgery.
Procedure: early removal of urinary catheter
The urinary catheter will be kept after surgery and be removed within 48 hours after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postoperative urinary retention incidence
Time Frame: From urinary catheter removed to 6 hours after removal
From urinary catheter removed to 6 hours after removal

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative urinary tract infection incidence
Time Frame: from postoperative day 1 to postoperative day 7
from postoperative day 1 to postoperative day 7
anxious status
Time Frame: postoperative day 1
measured by Kolcaba scale, Kolcaba scale scores from 30 to 112, higher scores mean the patients feel more comfortable during hospitalization (a better outcome).
postoperative day 1
comfort status
Time Frame: postoperative day 1
measured by hospital anxiety and depression scale (HAD scale), HAD scale scores from 0 to 20, a higher score means the patients feel more stressful during hospitalization (a worse result).
postoperative day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affiliated Hospital of Nanjing University of Chinese Medicine

Collaborators

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2021

Primary Completion (Actual)

June 20, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

November 26, 2024

First Submitted That Met QC Criteria

December 4, 2024

First Posted (Estimated)

December 5, 2024

Study Record Updates

Last Update Posted (Estimated)

December 5, 2024

Last Update Submitted That Met QC Criteria

December 4, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021NL-167-02
  • JD201807 (Other Grant/Funding Number: China Medical Education Association)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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