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Clinical Trials/NCT07413510
NCT07413510
Completed
Not Applicable

Comparison of Perioperative Outcomes Between Precision Nursing and Conventional Care in Laparoscopic Colorectal Cancer Surgery: a Randomized Controlled Trial

Jiangsu Cancer Institute & Hospital1 site in 1 country90 target enrollmentStarted: January 1, 2023Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Jiangsu Cancer Institute & Hospital
Enrollment
90
Locations
1
Primary Endpoint
Preoperative anxiety score

Overview

Brief Summary

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.

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:

  1. Preoperative: 30-minute personalized psychological counseling + music therapy;
  2. Intraoperative: Real-time body temperature monitoring (maintaining ≥36°C) + dynamic position optimization;
  3. 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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Precision Nursing Group

Experimental

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).

Intervention: Precision Nursing (Behavioral)

Conventional Care Group

Active Comparator

Participants in this arm receive routine perioperative clinical nursing, including standard preoperative health education, basic intraoperative monitoring, and postoperative standard care without personalized interventions.

Intervention: Conventional Clinical Nursing (Behavioral)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Jiangsu Cancer Institute & Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mei Fang

Nurse-in-Charge

Jiangsu Cancer Institute & Hospital

Study Sites (1)

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