- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07413510
Precision Nursing vs Conventional Care in Laparoscopic Colorectal Cancer Surgery: A Randomized Controlled Trial
Comparison of Perioperative Outcomes Between Precision Nursing and Conventional Care in Laparoscopic Colorectal Cancer Surgery: a Randomized Controlled Trial
This single-center randomized controlled trial compares the effects of precision nursing and conventional care in patients undergoing laparoscopic colorectal cancer surgery.
Precision nursing includes personalized preoperative psychological counseling, intraoperative body temperature and position management, and postoperative targeted recovery guidance. Conventional care follows routine clinical nursing procedures.
The study will assess differences in perioperative outcomes (such as anxiety, intraoperative hypothermia, postoperative nausea and vomiting, recovery time, and hospital stay) between the two groups, to provide evidence for optimizing nursing strategies for colorectal cancer surgery patients.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Background: Laparoscopic colorectal cancer surgery is a common treatment, but perioperative complications (e.g., hypothermia, nausea) and anxiety affect patient recovery. Precision nursing may improve these outcomes, but evidence from RCTs is limited.
Study Design: A parallel-group randomized controlled trial. 90 eligible patients are randomly assigned (1:1) to the precision nursing group or conventional care group.
Interventions:
Precision Nursing Group:
- Preoperative: 30-minute personalized psychological counseling + music therapy;
- Intraoperative: Real-time body temperature monitoring (maintaining ≥36°C) + dynamic position optimization;
- Postoperative: Individualized recovery guidance (early ambulation, dietary adjustment) based on patient condition.
Conventional Care Group: Routine clinical nursing (preoperative health education, intraoperative basic monitoring, postoperative standard care).
Outcome Measures:
Primary: Preoperative anxiety score (SAQ), intraoperative hypothermia rate, postoperative nausea and vomiting (PONV) incidence, time to first flatus, length of hospital stay; Secondary: Postoperative complication rate, nursing satisfaction score.
Statistical Analysis: Data are analyzed using SPSS 26.0. Continuous variables are compared with t-tests, categorical variables with chi-square tests. A p-value <0.05 is considered statistically significant.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210009
- Jiangsu Cancer Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients diagnosed with colorectal cancer and scheduled for laparoscopic surgery.
- Age 18 to 80 years old.
- Able to understand and complete the study questionnaires.
- Voluntarily agree to participate in this study and sign the informed consent form.
Exclusion Criteria:
- Severe cognitive impairment or mental illness.
- Emergency surgery patients.
- Severe cardiopulmonary, hepatic, or renal dysfunction.
- Patients who cannot cooperate with perioperative nursing interventions.
- Participation in other clinical trials that may affect this study.
Study Plan
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: Precision Nursing Group
Participants in this arm receive personalized perioperative care, including 30-minute preoperative psychological counseling, real-time intraoperative body temperature monitoring (maintaining ≥36°C), and postoperative individualized recovery guidance (early ambulation, dietary adjustment).
|
Personalized perioperative care including 30-minute preoperative psychological counseling, real-time intraoperative body temperature monitoring (maintaining ≥36°C), and postoperative individualized recovery guidance (early ambulation, dietary adjustment).
|
|
Active Comparator: Conventional Care Group
Participants in this arm receive routine perioperative clinical nursing, including standard preoperative health education, basic intraoperative monitoring, and postoperative standard care without personalized interventions.
|
Routine perioperative clinical nursing, including standard preoperative education, basic monitoring, and standard postoperative care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preoperative anxiety score
Time Frame: 1 day before surgery
|
Anxiety level of participants is evaluated using a validated Self-Rating Anxiety Scale (SAS).
The scale consists of 20 items, with total scores ranging from 20 to 80 points.
A higher score indicates a more severe level of preoperative anxiety.
|
1 day before surgery
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JSCH-CRC-NURS-2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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