Bladder cancer is the most prevalent malignancy of the lower urinary tract; radical cystectomy and urinary diversion are the gold standard treatment of muscle invasive bladder cancer.1,2 An ileal conduit is a commonly performed form of urinary diversion. The ileal conduit is not designed to store urine; rather, it rapidly moves urine through an abdominal stoma. Urinary effluent is stored within an external pouching system. The presence of an ileal conduit influences physiological, social, and psychological functions.3 Studies indicate that approximately 50% of patients with a urostomy experience stomal or peristomal complications.4
Surgeons at the Department of Urology of Shanghai Pudong Hospital, affiliated with Fudan University, have been performing radical cystectomy and urinary diversion via ileal conduit since 2008. However, the facility did not have a dedicated team of ostomy specialists providing postoperative care for these patients until 2014. This team provides a standardized postoperative care for patients with ileal conduit after discharge from the hospital. The purpose of this study was to investigate the effect of a nurse-led multicomponent intervention provided by the ostomy care team on stoma-related complications, self-efficacy, and health-related quality of life in patients with an ileal conduit.
We complete a randomized controlled trial (RCT); data were collected from January 2014 to June 2016. The target population was patients undergoing radical cystectomy and ileal conduit for management of muscle invasive urothelial cancer. The study setting was the Shanghai Pudong Hospital, affiliated with Fudan University Pudong Medical Center, Shanghai, China. Inclusion criteria were (1) adults 50 to 70 years of age, (2) no distant metastases, (3) absence of comorbid conditions (other malignant tumors, stroke, diabetes mellitus, chronic obstructive pulmonary disease, chronic low back pain, etc) likely to affect health-related quality of life, and (4) no history of mental illness and cognitive impairment (dementia). A random sequence software template was used to generate a set of random, nonrepeating, out-of-order natural numbers from 1 to 48. Each patient was assigned a random sequence number in order of operative time. Patients with odd numbers were allocated to the control group, and those with even numbers were allocated to the experimental group. Research procedures were reviewed and approved by the academic ethics committee of Shanghai Pudong Hospital (approval # PJ201404); written informed consents were acquired before randomization.
Participants randomly allocated to the control group received routine postoperative ostomy nursing by the general nurses in the inpatient ward. Patients and their families were educated about relevant knowledge, including selecting, emptying, and replacing an ostomy pouch, care of the ostomy and peristomal skin, diet and daily life guidance, and prevention of complications. Teaching was reinforced immediately prior to discharge. Patients were given a brochure describing ostomy care and informed about how to schedule an appointment with the outpatient ostomy care department if needed. Patients were advised to seek care from an ostomy nurse if they experienced peristomal skin damage.
Participants randomly allocated to the intervention (experimental) group received the same education and basic care as did the control group, along with a multicomponent intervention delivered by our ostomy care team after hospital discharge (Figure). The ostomy care team comprised 1 WOC/enterostomal therapy nurse and 3 RNs with specialized training in ostomy care provided by the certified enterostomal therapy nurse.
The multicomponent intervention included a health record for every individual that focused on the patient's self-management, recovery from ostomy surgery, ostomy care skills, diet, psychosocial assessment, stomal or peristomal complications, and pouching problems. In addition, participants in the experimental group received an educational intervention that focused on ostomy self-management; specifically, they attended lectures given by the ostomy care team monthly. Teaching included a pouching demonstration that included pouch removal, observation, cleaning, and replacement of a new pouch. The lectures also emphasized the importance of their participation in the patient's physical care and the need of ongoing emotional support. We confirmed that every patient and at least one family member attended the lecture in person. A physical assessment and care were performed by the ostomy care team monthly when they attended the lecture.
Participants in the intervention group also received a telephone call monthly from a member of the ostomy care team; during this call, the patient and family members were encouraged to discuss challenges with pouching, any stomal or peristomal complications, diet, lifestyle, physical activity, and psychosocial status. The caller also assessed involvement of family members during these monthly telephone calls.
Patients and families were also encouraged to attend an ostomy support group held quarterly. During these sessions, persons who had lived with an ostomy for more than 1 year were asked to share their experiences living with an ostomy. We observed that many patients experience psychosocial distress resulting in anxiety, social isolation, or other signs or distress. Therefore, we arranged 2 one-on-one psychological sessions with certified counselors for patients identified by the team as requiring additional psychosocial support.
A standardized form was developed to obtain demographic and pertinent clinical data; it was based on work completed as part of a master's thesis.5 Demographic data included gender, age, education level, marital status, and body mass index (BMI).
The Stoma Self-Efficacy Scale (SSES) was initially developed by Bekkers and colleagues.5 A Chinese language version of the SSES was developed and validated for use in this study.6,7 The scale comprises 28 items, divided into 2 dimensions (ostomy care self-efficacy and social self-efficacy) and 6 separate categories (dietary choices, sexual interest, sexual satisfaction, confidence in engaging in heavy manual labor, confidence in maintaining the vitality, confidence in self-nursing). Respondents were asked to choose 1 of 5 response categories, indicating not being confident at all (1 point), slightly confident (2 points), fairly confident (3 points), highly confident (4 points), and extremely confident (5 points). The correlation between the Ostomy Care Self-Efficacy (Cronbach α= 0.94) and the Social Self-Efficacy (Cronbach α= 0.95) is relatively high (Pearson r = 0.73).6 Cumulative scores range from 28 to 140 points; scores <65 indicated low self-efficacy, scores between 66 and 102 indicated moderate self-efficacy, and scores of 103 or greater indicated high self-efficacy.
Health-Related Quality of Life
The City of Hope Quality of Life-Ostomy (COHQOL-O) instrument is a validated instrument designed to assess health-related quality of life in patients with fecal or urinary ostomies.8 Gao and colleagues9 developed and validated a Chinese language version of the COHQOL-O questionnaire. The scale contains 32 items that measure 4 health-related quality-of-life domains: physical well-being, psychological well-being, social well-being, and spiritual well-being. Each item contains a 10-point Likert scale, and certain items are reverse coded. A cumulative score is obtained by adding all items; higher scores reflect higher well-being. Cronbach coefficients of the 4 domains were 0.860, 0.885, 0.864, and 0.686, respectively. The content validity of all the entries was greater than 0.7 and the retest reliability in the 2 weeks was greater than 0.8, indicating that the instrument has good reliability and validity.10
Data were collected over a period of 6 months. After obtaining informed consent and random allocation to control group or intervention group, participants were asked to complete the demographic form, SSES, and COHQOL-O. In addition, the incidence of 2 prevalent ostomy-related complications, uric acid crystals and peristomal moisture-associated skin damage (MASD), were assessed over the 6-month period by Y.H.Z. Peristomal MASD is defined as inflammation with or without erosion caused by exposure to effluent (urine) from the ostomy.11 Uric acid crystals appear as gravel-like white powder crystals that adhere to the peristomal skin; they are attributed to diet and poor drainage and can cause local irritation.12
All data were analyzed using SPSS software, version 20.0 (Statistical Package for the Social Sciences, Chicago, Illinois). Fisher's exact test was used to compare the incidence of ostomy-related complications between the 2 groups. Independent-samples t tests were used to compare mean SSES and COHQOL-Q scores between groups, and dependent-groups t tests were calculated when comparing within-group values at baseline and at 6 months; P values less than .05 were deemed statistically significant.
Forty-eight patients who met inclusion criteria were enrolled and randomized to the control or intervention group. Forty-six participants completed the study (1 patient died in the control group and 1 patient in the experimental group was lost to follow-up). The mean age of the control group was 66.13 ± 11.01 years; their average BMI was 21.61 ± 2.02; 91.3% were male; and 82.6% were married. The mean age of the experiment group was 65.04 ± 11.61 years; their average BMI was 21.87 ± 1.93; 95.7% were male; and 73.9% were married. No differences in age, education level, marital status, and BMI were found when demographic characteristics of the groups were analyzed (Table 1).
TABLE 1. -
Demographic Characteristics of Participants
||Test and P Value
|Gender, n (%)
||χ2 = 0.357, P = .550
|Age, mean ± SD
||66.13 ± 11.01
||65.04 ± 11.61
t = 0.326, P = .746
|Education level, n (%)
|No formal education
||χ2 = 1.259, P = .533
|Middle school and higher
|Marital status, n (%)
||χ2 = 0.511, P = .475
|BMI, mean ± SD
||21.61 ± 2.02
||21.87 ± 1.93
t = 0.455, P = .651
Abbreviation: BMI, body mass index.
Differences were found when occurrences of stomal or peristomal complications were compared. Assessments identified 6 cases of uric acid crystals and 1 case of peristomal MASD in the control group versus 1 case of uric acid crystals in the experimental group. Occurrences of these 2 peristomal skin complications were significantly lower in the intervention group versus the control group (4.35% vs 30.43%, P = .047; Table 2).
TABLE 2. -
Peristomal MASD and Uric Acid Crystal Formation Incidence at 6 Months
||Uric Acid Crystal, n (%)
||Peristomal MASD, n (%)
||Total, N (%)
Abbreviation: MASD, moisture-associated skin damage.
Analysis revealed no differences in the mean scores of the SSES at baseline between the groups; in contrast, participants in the multicomponent intervention had significantly higher mean SSES scores at 6 months (107.13 ± 11.87 vs 85.65 ± 12.87, P = .000), indicating greater self-efficacy in stoma care (Table 3). Mean scores for participants in the intervention group were significantly higher for multiple items: (1) stoma care (53.09 ± 7.03 vs 43.52 ± 5.29, P = .000), (2) social performance (33.48 ± 4.44 vs 26.43 ± 5.33, P = .000), (3) diet selection (4.52 ± 0.67 vs 3.22 ± 1.06, P = .000), (4) confidence in heavy manual labor (3.14 ± 1.02 vs 2.26 ± 0.84, P = .022), (5) confidence in physical activity (4.09 ± 0.95 vs 2.87 ± 1.03, P = .000), and (6) self-care confidence (4.34 ± 0.85 vs 3.48 ± 1.11, P = .005). No significant differences between groups were found when items querying confidence in sexual life and sexual satisfaction.
TABLE 3. -
Scale Scores at 6 Months (Mean ± SD)
||Test and P Value
||43.52 ± 5.29
||53.09 ± 7.03
t =−5.146, P = .000
||26.43 ± 5.33
||33.48 ± 4.44
t =−4.389, P = .000
||3.22 ± 1.06
||4.52 ± 0.67
t =−4.852, P = .000
|Confidence in sexual life
||1.78 ± 1.11
||1.91 ± 0.95
t =−0.856, P = .379
|Confidence in sexual satisfaction
||1.48 ± 0.81
||1.69 ± 1.82
t =−0.772, P = .445
|Confidence in heavy manual labor
||2.26 ± 0.84
||3.14 ± 1.02
t =−2.366, P = .022
|Confidence in staying active
||2.87 ± 1.03
||4.09 ± 0.95
t =−5.053, P = .000
||3.48 ± 1.11
||4.34 ± 0.85
t =−2.978, P = .005
||85.65 ± 12.87
||107.13 ± 11.87
t =−5.882, P = .000
Cumulative mean scores in the COHQOL-O were significantly higher for participants in the intervention group at 6 months (154.48 ± 16.01 vs 138.26 ± 13.42, P = .001;Table 4). Analysis of individual items indicated that participants allocated to the intervention group had higher scores on physiological health (38.09 ± 7.39 vs 33.70 ± 6.75, P = .041), psychological health (53.04 ± 7.91 vs 47.87 ± 6.46, P = .019), social health (43.78 ± 5.62 vs 38.96 ± 5.05, P = .004), and spiritual health (19.57 ± 2.54 vs 17.74 ± 1.89, P = .008).
TABLE 4. -
City of Hope Quality of Life
Scores at 6 Months (Mean ± SD)
||Test and P Value
||33.70 ± 6.75
||38.09 ± 7.39
t = 2.104, P = .041
||47.87 ± 6.46
||53.04 ± 7.91
t = 2.430, P = .019
||38.96 ± 5.05
||43.78 ± 5.62
t = 3.065, P = .004
||17.74 ± 1.89
||19.57 ± 2.54
t = 2.769, P = .008
||138.26 ± 13.42
||154.48 ± 16.01
t = 3.724, P = .001
Results indicated that intervention reduced occurrences of 2 prevalent peristomal skin complications, formation of uric acid crystals and peristomal MASD. The incidence rates of peristomal MASD following ostomy surgery for any form of peristomal skin damage vary from 10% to 70%.11 Limited evidence suggests that education on ostomy self-management can reduce the incidence of these peristomal skin complications.13
Our findings indicated that participants who received the nurse-led multicomponent intervention achieved significantly greater self-efficacy in ostomy care than did participants in the control group. We identified one prior study that suggested that telephone follow-up may improve patient self-care ability measured by the Chinese version of the SSES.14 The study was an RCT with 103 participants, and patients in the study group received 2 to 3 nurse telephone calls in the follow-up period. Our results also showed that mean COHQOL-O scores of patients in the experimental group were significantly higher than those in the control group.
Study findings suggest that family support is important to restoration of physical and psychosocial health following creation of a urostomy and nursing care of patients after urostomy. Therefore, we recommend actively involving family members in the postoperative care of individuals following urostomy surgery and encouraging them to provide psychosocial support to the patient.
The aim of our multicomponent intervention was not limited to repetitive education in order to increase ostomy-related knowledge. Rather, our goal was to improve the individual's and family's ostomy management skills via demonstration and return demonstration of pouching and ostomy care. We also aimed to identify and address individual needs throughout the initial 6 months following ostomy surgery. We used a combination of scheduled educational sessions, telephone calls, and encouragement to participate in a support group to maximize self-efficacy and health-related quality of life. Nevertheless, we observed that 2 components of self-efficacy (“confidence in sexual life” and “confidence in sexual satisfaction”) did not differ between groups. Our intervention did not specifically address sexual function and physical activity following ostomy surgery that has been recommended.15 We therefore recommend inclusion of these factors to assist patient managing a new urostomy.
This study has several limitations that may affect generalizability of findings. The sample sizes were relatively small and data were collected at a single facility. Some patients in the intervention group received additional counseling; the effect of this intervention on health-related quality of life and stoma-related self-efficacy is not known. There are many peristomal skin complications, but we only evaluated 2 of them.
Our findings suggest that a nurse-led, multicomponent, structured intervention reduced 2 peristomal skin complications, improved stoma-related self-efficacy, and enhanced health-related quality of life. We acknowledge the limited number of certified WOC/enterostomal nurses and recommend training of other nurses to enhance the ability of frontline hospital-based nurses when providing care to patients with a new urostomy.
This study was supported by Special Fund for Science and Technology Development of Pudong Health and Family Planning Commission of Shanghai (PW2017A-23) and Key Discipline Construction Project of Pudong Health and Family Planning Commission of Shanghai (grant no. PWZxk2017-21)
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