A Study on Early Removal of Urinary Catheter After Gastric Cancer Surgery Applying ERAS Protocols
2 other identifiers
interventional
181
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedFirst Submitted
Initial submission to the registry
November 26, 2024
CompletedFirst Posted
Study publicly available on registry
December 5, 2024
CompletedDecember 5, 2024
November 1, 2024
2.5 years
November 26, 2024
December 4, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
postoperative urinary retention incidence
From urinary catheter removed to 6 hours after removal
Secondary Outcomes (3)
postoperative urinary tract infection incidence
from postoperative day 1 to postoperative day 7
anxious status
postoperative day 1
comfort status
postoperative day 1
Study Arms (2)
immediate removal of urinary catheter
EXPERIMENTALThe urinary catheter will be removed immediately after surgery.
early removal of urinary catheter
OTHERThe urinary catheter will be kept after surgery and be removed within 48 hours after surgery.
Interventions
Immediate urinary catheter removal indicates that the urinary catheter will be removed immediately after surgery.
The urinary catheter will be kept after surgery and be removed within 48 hours after surgery.
Eligibility Criteria
You may qualify if:
- underwent elective radical gastrectomy
- applied ERAS protocols during perioperative period
- aged 18～80 years old
You may not qualify if:
- benign prostatic hyperplasia
- urinary system stones, tumors, strictures, deformities or surgeries
- pelvic surgery history
- abnormal preoperative urine routine
- medication intake that affects urination function
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Affiliated Hospital of Nanjing University of Chinese Medicine
Nanjing, Jiangsu, 025, China
Related Publications (1)
Wei C, Wang G, Wang HF, Pan HF, Jiang ZW, Qu MW. Immediate versus early urinary catheter removal after gastrectomy under enhanced recovery after surgery protocols: randomized clinical trial. BJS Open. 2025 Jul 1;9(4):zraf088. doi: 10.1093/bjsopen/zraf088.
PMID: 40827509DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2024
First Posted
December 5, 2024
Study Start
December 10, 2021
Primary Completion
June 20, 2024
Study Completion
June 30, 2024
Last Updated
December 5, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share