Conversion of Evidence and Applied Research on Intermittent Catheterization After Radical Hysterectomy

NCT06529107 | Recruiting

• 1 other identifier: 2023203
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators summarize the existing best evidence of intermittent catheterization in patients after radical cervical cancer surgery from the perspective of clinical translation of evidence through systematic search, evaluation and evidence integration, construct a nursing protocol of intermittent catheterization for patients after radical cervical cancer surgery based on the best evidence combined with the clinical context, and explore the clinical application effect of the above nursing protocol. It will provide a reference basis for the development of the standardization and management of intermittent catheterization for postoperative patients with cervical cancer in China, as well as the development of guidelines for intermittent catheterization after radical cervical cancer surgery.

Conditions

Intermittent Catheterization; Conversion of Evidence

Outcome Measures

Primary Outcomes (1)

• Incidence of urinary complications

  the occurrence of urologic complications within 2 months after discharge of the patients from the hospital for follow-up, which in this study included urinary tract infections, urethral injuries, bladder stones, hydronephrosis

  Within 2 months of discharge

Secondary Outcomes (5)

• Intermittent Catheterization Compliance Scale

  Pre-intervention, immediately post-intervention, and 1 month post-discharge

• 12-Item Short Form Survey

  Pre-intervention, immediately post-intervention, and 1 month post-discharge

• Self-Rating Anxiety Scale

  Pre-intervention, immediately post-intervention, and 1 month post-discharge

• Intermittent Catheterization Confidence Scale

  Pre-intervention, immediately post-intervention, and 1 month post-discharge

• Utilization of health services

  Within 2 months of discharge

Study Arms (2)

A best evidence-based protocol for intermittent catheterization

EXPERIMENTAL

Behavioral: intermittent catheterization protocol based on the best evidence

Routine intermittent catheterization care

NO INTERVENTION

Interventions

intermittent catheterization protocol based on the best evidence BEHAVIORAL

A best evidence-based protocol for intermittent catheterization after radical cervical cancer surgery

A best evidence-based protocol for intermittent catheterization

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≧ 18 years old
• Radical cervical cancer surgery and intermittent catheterization were performed at the Institute's hospital
• Patients or their family members can operate a smartphone
• No cognitive or psychiatric disorders, and can communicate effectively

You may not qualify if:

• People with serious heart, brain, lung and other important organ diseases
• People with water, electrolyte, acid-base balance disorders at the beginning of intermittent catheterization
• People with previous serious renal diseases, bladder and urethra surgery
• People with urinary tract infections
• People who did not complete all interventions or data collection
• People who voluntarily withdrew from the study or died during the study period;
• Refuse to participate in this study

Sponsors & Collaborators

• West China Second University Hospital: lead

Study Sites (1)

West China Second University Hospital, Sichuan University

Chengdu, Sichuan, China

RECRUITING

Central Study Contacts

Lu Xing

CONTACT

+8619827473462; xinglu_0707@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: deputy head nurse

Study Record Dates

• First Submitted: July 20, 2024
• First Posted: July 31, 2024
• Study Start: January 1, 2024
• Primary Completion: December 10, 2024
• Study Completion: December 31, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)