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The study obtained institutional ethics approval before any data abstraction and ensured de-identification of all records (Approval No.: 2023-YZ-061). Written informed consent was obtained from all participants prior to data collection and follow-up. All procedures complied with institutional infection-prevention and privacy policies throughout care delivery and data handling.
Materials and equipment
Prepare two- or one-piece ostomy pouches (flat and convex), skin barriers, moldable rings, adhesive aids and removers, protective film or powder, ostomy scissors, a stoma measuring guide, sterile 0.9% saline, gauze, gloves, printed and audiovisual education materials, tele-follow-up tools, and quality-check forms.
Study design and groups (Retrospective)
An overview of the retrospective study design, cohort assignment, and assessment time points is shown in Figure 1. Identify all eligible patients aged ≥45 years who underwent colostomy between January 2022 and December 2023 at the study center. Apply predefined inclusion and exclusion criteria as follows, and confirm availability of baseline and 1-month outcome records. Include patients aged ≥45 years who underwent colostomy at the study center between January 2022 and December 2023 and had complete baseline records and documented 1-month follow-up outcome assessments. Exclude patients with missing key baseline variables or 1-month outcomes, those who underwent stoma reversal or major reoperation within 1 month, those unable to complete the ESCA/SAS/SDS/COH-QOL-OQ assessments due to severe cognitive/communication impairment, and those transferred to another facility or lost to follow-up before the 1-month assessment. Categorize patients according to the care they actually received into a routine-care cohort and a professional-pathway cohort; note that grouping reflects real-world practice rather than random assignment.
Pre-discharge education
Provide two one-to-one education sessions of 15-20 min each, spaced at least 24 h apart. Explain ostomy anatomy and function, daily self-care steps, red-flag signs and actions, diet and activity progression, and indications for contacting the care team. Demonstrate pouch change and require a complete return demonstration using a six-step checklist (cut, clean, measure, apply, press, check). Issue printed and visual materials and set the target of independent pouch change in ≤20 min without missed steps. Verify mastery before discharge.
Stoma and peristomal skin care
Replace the pouch every 3-5 days or as soon as leakage occurs. Cut the baseplate opening 1-2 mm larger than the stoma diameter, apply the system, and press evenly for 1-2 min to secure adhesion (or follow manufacturer instructions where they differ). Clean the peristomal area with 30-50 mL of warm water or 0.9% saline and avoid irritants or soap residue. Position the patient to minimize contamination during changes; trim hair if required to improve sealing. Verify that the appliance remains leak-free for ≥72 h and that the peristomal skin is intact, dry, and free of an erythematous rim >1 cm. If erythema exceeds 1 cm, if moisture-associated damage or erosion is present, or if there is suspected infection (pain, heat, purulent drainage, or fever ≥38 °C), escalate care promptly: reinforce with barrier film plus convex system and ring and reassess within 48 h; obtain a wound swab/culture and arrange same-day surgical review when infection is suspected. If stenosis is suspected due to pencil-thin output or obstructive symptoms, arrange a colorectal assessment within 48 h and avoid forceful probing. For high-output stoma >1200 mL/24 h, initiate fluid and electrolyte support and adjust diet, then reassess within 24 h.
Nurse-led psychological support
In both cohorts, anxiety and depression were assessed using the Self-Rating Anxiety Scale (SAS) and the Self-Rating Depression Scale (SDS) at baseline and at 4 weeks as study outcomes. For the routine-care cohort, psychological care followed usual practice, which consisted of brief emotional reassurance during routine ward rounds and discharge education, provision of standard written instructions, and referral to mental-health services at the clinician's discretion when marked distress was identified; no structured, scheduled psychological sessions or tracking tools were routinely implemented. In contrast, the professional nursing pathway cohort received a standardized nurse-led psychological support module consisting of weekly 15 min sessions for 4 weeks that included cognitive restructuring focused on negative automatic thoughts, 3-5 min of breathing relaxation training, and a planned pleasant activity to be practiced daily; adherence was documented on a tracking card. Participants were referred to mental-health services when SAS/SDS scores met moderate or higher thresholds or when clinically indicated.
Lifestyle and diet
Advise loose clothing to avoid stoma irritation and restrict lifting >5 kg during the first 4 weeks. Progress physical activity from 2000-4000 steps/day in week 1 to 6000-8000 steps/day by week 4 as tolerated. Implement a low-residue, small-frequent-meals plan during weeks 1-2, then reintroduce gas-producing or high-fiber foods one at a time from week 3 while observing tolerance for 48 h after each new item. Ensure daily fluid intake of 1500-2000 mL unless contraindicated. Confirm the absence of nausea, bloating, or diarrhea during reintroduction and that bowel function remains stable.
Discharge guidance and follow-up
Provide written checklists for stoma change steps, red-flag signs, and points of contact. Schedule a week-1 tele-follow-up of about 10 min and week-2 and week-4 clinic or video reviews. Collect outcome scales and complication logs at scheduled contacts and reinforce techniques if leakage or skin issues recur. At the week-4 review, confirm independent technique and adherence to the pathway.
Outcome measures and assessment schedule
Assess outcomes at baseline (T0) and 1 month (T1). Measure self-care ability using the Self-Care Ability Assessment Scale (ESCA) with total and subscale scores. Evaluate psychological status using SAS and SDS standard scores. Assess quality of life using the City of Hope Quality of Life-Ostomy Questionnaire (COH-QOL-OQ) with total and domain scores. Record early complications, including infection, stenosis, bleeding, peristomal dermatitis, and high output, and calculate a composite incidence. Evaluate nursing satisfaction at T1 with a four-level scale (very satisfied, basically satisfied, generally satisfied, dissatisfied) and report as n (%). Ensure that all scales are completed at both time points and that any adjudication of complications is documented.
Data management and quality assurance
Train nursing staff in the use of checklists and documentation. Audit approximately 10% of records for completeness and internal consistency. When feasible, separate outcome assessment from day-to-day caregivers to reduce measurement bias, and record protocol deviations with corrective actions. Conclude the pathway after completion of the 4-week follow-up, verification of outcomes, and closure of the quality-control log.
Statistical analysis
Analyze data with SPSS 25.0 (or equivalent). Summarize continuous variables as mean (SD) or median (IQR) after Shapiro-Wilk testing and choose independent-samples t tests or Mann-Whitney U tests; accordingly, summarize categorical variables as n (%) and compare using χ2 or Fisher's exact tests. Report two-sided p-values with α = 0.05 and provide effect sizes with 95% confidence intervals (e.g., Cohen's d for continuous outcomes; risk ratio or risk difference for binary outcomes). For primary outcomes, perform ANCOVA or multivariable regression adjusted for prespecified baseline covariates (e.g., age, sex, key comorbidities). Control multiple comparisons where applicable (e.g., Benjamini-Hochberg FDR). Conduct sensitivity analysis for missing data handling and model specifications. State all software and package versions.