Statement of ethics
The study was approved by the ethics committee of First Affiliated Hospital of Xiamen University (Approval No. [2024]152). All the materials used in this study are listed in the Table of Materials.
Study design
A single-center, cross-departmental prospective cohort study was conducted in the Departments of Obstetrics and Gynecology, Colorectal Surgery, and General Surgery of First Affiliated Hospital of Xiamen University. Female patients who underwent enterostomy between January and December 2024 were eligible. Within 1 week after surgery, IPV exposure was assessed using the victimization items of the revised Conflict Tactics Scales (CTS2) together with a structured interview. Occurrence and frequency were analyzed separately. For occurrence scoring, each victimization item was coded as 0 when the act had not occurred and 1 when it had occurred at least once during the preceding 12 months; endorsement of at least one CTS2 victimization item, or disclosure of economic control during the structured interview, defined IPV exposure. Medical records of violence-related injuries, photographs, and police records were used as corroborative evidence but were not required for classification. The two researchers independently reached the same baseline classification for all 188 participants. Fifty-four participants met the binary exposure definition and were assigned to the IPV group, whereas 134 reported no qualifying exposure and were assigned to the non-IPV group; the resulting IPV exposure rate was 28.7% (54/188). For frequency scoring, the CTS2 response categories were converted to estimated frequencies of 0, 1, 2, 4, 8, 15, and 25 and summed across the victimization items. Among the 54 IPV-exposed participants, the observed frequency score ranged from 9 to 44; scores < 15, 15–30, and >30 were described as low, intermediate, and high frequency, respectively. These study-defined categories were used only for descriptive presentation and did not determine group assignment. Baseline group membership was retained throughout follow-up, irrespective of subsequent changes in reported IPV exposure. The study flow, cohort assembly, and follow-up schedule were summarized in Figure 1.
Sample size calculation
Sample size was estimated using PASS 15.0 software. Based on prior studies10, the authors assumed that the proportion of good stoma adaptation at 6 months would be 65% in the non-IPV group and 35% in the IPV group. With a two-tailed α of 0.05, power (1−β) of 0.90, and a 15% allowance for potential attrition, the minimum required sample size was 168.
Study participants
During the study period, 188 women who underwent enterostomy for colorectal cancer, gynecologic tumors involving the intestinal tract, intestinal obstruction, intestinal perforation, or other indications were assessed for eligibility. None was excluded because of a severe psychiatric or cognitive disorder (n = 0), severe major-organ dysfunction or an anticipated survival of less than 11 months (n = 0), a severe postoperative complication requiring emergency reoperation (n = 0), previous enterostomy or major organ transplantation (n = 0), or refusal or inability to complete the required follow-up and objective assessments (n = 0); consequently, all 188 women were enrolled. All 188 enrolled participants completed the 11-month follow-up, yielding an observed attrition rate of 0%. These patients were treated between January and December 2024 in the Departments of Obstetrics and Gynecology, Colorectal Surgery, and General Surgery; 30 participants were recruited from Obstetrics and Gynecology, 82 from Colorectal Surgery, and 76 from General Surgery. Potential participants were initially identified through screening of electronic medical records. Trained researchers then conducted face-to-face interviews to explain the study objectives and procedures. After providing written informed consent, eligible participants were enrolled, categorized according to their intimate partner violence (IPV) exposure status, and assigned individual follow-up files. Data on demographic characteristics, disease- and surgery-related variables, psychological assessments, objective physiological indicators, and nursing outcomes were systematically collected throughout the follow-up period.
Inclusion and exclusion criteria
Inclusion criteria: Age ≥18 years; conscious and oriented; capable of verbal communication and reading comprehension sufficient to complete questionnaires, assessments, and follow-up procedures; Undergoing first-time enterostomy (either permanent or temporary), with stable stoma morphology postoperatively and no immediate severe complications; Currently in an intimate partner relationship (married or cohabiting), with potential exposure to IPV; Willingness to participate and provision of written informed consent.
Exclusion criteria: Preoperative diagnosis of severe psychiatric disorders (e.g., schizophrenia, major depressive disorder) or cognitive impairment; Severe dysfunction of major organs (e.g., heart, liver, kidney) with an anticipated survival duration of less than 11 months; Presence of severe postoperative complications (e.g., stoma necrosis, severe infection) necessitating emergency reoperation; History of previous enterostomy or major organ transplantation; Refusal to participate, inability to comply with follow-up requirements, or unwillingness to undergo assessment of objective indicators.
Grouping
Within 1 week after surgery, IPV exposure was assessed using the revised Conflict Tactics Scales (CTS2)11 combined with structured interviews. Where available, supporting materials (e.g., medical records documenting violence-related injuries and photographs of physical injuries) were collected. Baseline exposure status was determined from the participant’s CTS2 occurrence responses and disclosures made during the structured interview, whereas medical records, photographs, and police records were used solely as corroborative evidence and were not required for classification. Patients reporting any form of violence (physical violence, emotional violence, economic control, etc.) were allocated to the IPV group, while those reporting no IPV were allocated to the non-IPV group. The two researchers independently reached the same baseline exposure classification for all 188 participants; consequently, no case required consensus adjudication. Ultimately, 54 patients were included in the IPV group and 134 patients in the non-IPV group.
Outcome measures
Baseline data comparison table: Collected within 1 week after surgery. Objective indicators included age, surgical duration, intraoperative blood loss, stoma diameter, primary disease type, and surgical approach; subjective indicators included educational level and economic income. These variables were used to evaluate baseline comparability between groups. IPV occurrence and objective evidence table: Collected at baseline (within 1 week after surgery) and at 6 months postoperatively. In addition to IPV incidence and type, objective indicators (number of medical visits for violence-related injuries, cases with photographic evidence of injury, and records of police involvement) were recorded to strengthen the assessment.
Longitudinal psychological adaptation and objective physiological indicators: Collected at 1, 3, 6, 9, and 11 months postoperatively. Psychological outcomes were assessed using the 20-item self-rating anxiety scale (SAS) and the 20-item self-rating depression scale (SDS), both of which use four-point response options; higher standard scores indicate greater symptom burden, and scores of ≥50 and ≥53 were used to identify clinically relevant anxiety and depressive symptoms, respectively12. Because only total scores were retained in the analytic dataset, cohort-specific internal-consistency coefficients were not calculated. Physiological indicators included serum cortisol (Cor) levels and stoma mucosal blood supply scores (0–3 points; 3 indicating normal blood supply, with lower scores indicating poorer perfusion).
Subjective and objective nursing outcome indicators: Collected at the 11-month follow-up endpoint. Objective outcomes included stoma complication incidence, readmission rate, stoma-care compliance rate (assessed by on-site evaluation; 1 = compliant, 0 = non-compliant), time to first postoperative ambulation, and length of hospital stay. Subjective outcomes included adherence to the postoperative nursing plan, assessed using a study-specific 12-item scale with four response options per item and a total score range of 12–48; scores ≥36 indicated higher adherence. The scale had not undergone formal external psychometric validation; therefore, the outcome was treated as exploratory. Quality of life was assessed using the EORTC QLQ-C3013 (five functional dimensions, including physical, emotional, and social functioning; higher scores indicate better quality of life).
Association between IPV frequency and objective stress indicators: CTS2 frequency scores were analyzed in relation to contemporaneous serum cortisol concentrations at 1, 3, 6, 9, and 11 months postoperatively among participants classified as IPV-exposed at baseline.
Objective diagnosis and intervention of stoma complications: Collected from 1 to 11 months postoperatively. The number and proportion of complications, diagnostic basis (physical examination and/or imaging), and the number of interventions for each complication type (e.g., peristomal dermatitis, stoma prolapse) were recorded.
Department-level comparisons of IPV exposure and objective stress indicators: Collected within 1 week after surgery to compare IPV exposure rates and mean Cor levels among departments.
Risk factors for adverse outcomes: Collected at the 11-month follow-up endpoint. Objective risk factors and IPV exposure status were included to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for adverse nursing outcomes (defined as the occurrence of complications).
Quality control
All researchers received standardized training on assessment tools and objective indicator testing procedures. Data were double-entered and cross-checked to improve accuracy. Outcome assessors were not formally blinded to IPV status; however, serum cortisol measurements were obtained using standardized laboratory procedures, and stoma complications were assessed according to prespecified clinical criteria. Follow-up completion was supported through text-message reminders and dedicated follow-up staff; all 188 participants completed the 11-month follow-up, and no participant was lost to follow-up. Objective indicator testing adhered to laboratory standards and clinical assessment criteria to reduce measurement error.
Statistical analysis
SPSS 26.0 was used for statistical analyses with a two-tailed α of 0.05. Categorical variables are presented as n (%) and compared using the χ2 test. Continuous variables are presented as mean ± standard deviation (SD). Independent-samples t-tests were applied to normally distributed, homoscedastic data; the Mann-Whitney U test was used for non-normally distributed data. Repeated-measures analysis of variance was used to compare longitudinal changes in SAS, SDS, and serum cortisol, with group, time, and group-by-time effects evaluated. Residual distributions were examined graphically, homogeneity of variance was assessed using Levene’s test, and sphericity was evaluated using Mauchly’s test; Greenhouse–Geisser corrections were applied when sphericity was violated. When an omnibus longitudinal effect was significant, Bonferroni correction was applied to the five time-specific between-group comparisons within that outcome. The same correction was applied to the five correlations between CTS2 frequency scores and serum cortisol concentrations. No global adjustment was applied across distinct prespecified secondary outcomes, which were interpreted separately using exact two-sided p values. Because the stoma mucosal blood supply score was an ordinal measure ranging from 0 to 3, between-group comparisons at each postoperative time point were performed using the Mann–Whitney U test. Pearson correlation analysis was used to assess associations between CTS2 frequency scores and serum cortisol concentrations. Multivariate logistic regression was used to identify independent risk factors for adverse postoperative outcomes. All baseline and longitudinal variables included in the final analyses were complete for the 188 participants. Blank entries in conditional fields, such as complication type among participants without a stoma complication or supporting evidence among participants without IPV exposure, represented absence or non-applicability rather than missing data; therefore, no statistical imputation was performed.