Original article
Effects of pelvic floor muscle exercise on faecal incontinence in rectal cancer patients after stoma closure Y.-H. LIN, RN, PHD, PROFESSOR, Department of Nursing, I-Shou University, Kaohsiung, H.-Y. YANG, RN, PHD, ASSISTANT PROFESSOR, Department of Nursing, Mackay Medical College, Taipei, S.-L. HUNG, RN, PHD, ASSISTANT PROFESSOR, Department of Nursing, National Tainan Junior College of Nursing, Tainan, H.-P. CHEN, BSC, PHYSICIAN, Division of Colon and Rectal Surgery, Department of Surgery, E-DA Hospital, Kaohsiung, K.-W. LIU, BSC, PHYSICIAN, Division of Colon and Rectal Surgery, Department of Surgery, E-DA Hospital, Kaohsiung, T.-B. CHEN, PHD, ASSOCIATE PROFESSOR, Department of Medical Imaging and Radiological Science, I-Shou University, Kaohsiung, & S.-C. CHI, RN, MSN, DEAN,
Nursing Department, E-DA Hospital, Kaohsiung, Taiwan LIN Y.-H., YANG H.-Y., HUNG S.-L., CHEN H.-P., LIU K.-W., CHEN T.-B. & CHI S.-C. (2016) European Journal of Cancer Care 25, 449–457 Effects of pelvic floor muscle exercise on faecal incontinence in rectal cancer patients after stoma closure The purpose of this study was to examine the effects of pelvic floor muscle exercise (PFME) on the faecal incontinence (FI) of rectal cancer patients following stoma closure. Participants were randomly distributed into an exercise group (n = 27) and non-exercise group (n = 26). An experimental design and longitudinal approach were implemented for data collection. Baseline data were collected at 1 day before discharge, and then PFME was taught before the patients were discharged from the hospital. We collected data and followed up with the patients at their pre-discharge visit and at 1, 2, 3, 6 and 9 months after discharge. The Cleveland Clinic Faecal Incontinence (CCI) score was used to measure patient outcome. PFME proved to effectively decrease the degree of FI in stoma closure recipients. The FI score of the exercise group significantly decreased from 8.37 to 2.27 after PFME compared with that of the non-exercise group (from 8.54 to 2.58). The generalised estimation equation tests showed that both group and time were significantly different. The tests also indicated that although PFME appeared to hasten the decline of incontinence, this effect was no longer detectable at 9 months; thus, it may be an effective intervention for FI when implemented up to half a year after discharge.
Keywords: faecal incontinence, pelvic floor muscle exercise, rectal cancer, stoma closure.
IN T R O D U C T I O N Colorectal cancer (CRC) comprised the most new cases of any type of cancer and was the third leading cause of cancer-related deaths in Taiwan from 2001 to 2012
Correspondence address: Yu-Hua Lin, Department of Nursing, I-Shou University, No. 8, Yida Road., Yanchao District, Kaohsiung 82445, Taiwan (R.O.C.) (e-mail: [email protected]; [email protected]). Ethical approval: Ethical approval was obtained from participants’ hospital institutional review boards.
Accepted 6 January 2015 DOI: 10.1111/ecc.12292 European Journal of Cancer Care, 2016, 25, 449–457
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(Ministry of Health and Welfare 2013). CRC ranked third in most new cases and most cancer deaths in the United States, with an estimated 142 820 new cases and 50 830 deaths in 2013 (Siegel et al. 2013). For cancers located in the sigmoid colon (close with rectum junction) and rectum (especially the lower rectum), lower anterior resection (LAR) is considered to be the optimal treatment. However, some patients may need a temporary stoma for defecation for several months after the procedure (Lin 2009; Tokoro et al. 2013). It takes approximately three or more months after surgery for the anal tissues of patients to recover, at which point the stoma is usually closed, and the patient regains
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normal anal defecation (Ko et al. 2008). However, due to surgical damage of the anal sphincter and its associated nerves (Chatwin et al. 2002), 30–70% of patients experience bowel dysfunction, including stool frequency, faecal urgency, diarrhoea and faecal incontinence (FI) (Rao 2004; Vironen et al. 2006; Varpe et al. 2011). These symptoms affect patients’ daily activities, work and quality of life (Norton et al. 2003; Mahony et al. 2004; Yu & Dai 2004; Liou & Chen 2008; Lin 2009; Markland et al. 2009). Faecal incontinence is defined as the inadvertent passage of stool, soiling or excessive flatulence (Nygaard et al. 2008; Markland et al. 2009; Alsheik et al. 2012). Previous studies have found that 10–85% of patients have varying degrees of FI symptoms after stoma closure, and these faecal changes last from 3 months to 1 year after surgery (Yu & Dai 2004; Ko et al. 2008). Clearly, FI affects patients’ lives and is a source of embarrassment for them. The fear of such episodes may limit patients’ activities and carry social stigma (Rao 2004; Varpe et al. 2011). Although the impact of FI on LAR recipients has been well documented, reports in the literature on FI and interventions for improvement are still sparse in Taiwan. It is important to understand the changes that can occur as a result of LAR, including the degrees of increased FI. As an intervention, some studies have reported that pelvic floor muscle exercise (PFME) can resolve FI (Shamliyan et al. 2007). Visser et al. (2014) have conducted a systematic review, finding that PFME is a useful rehabilitation technique for improving FI after LAR and should be considered as the initial treatment for patients with FI (Rieger et al. 1997). One study has revealed that after 4 months of PFME and biofeedback treatment, 75% of patients with FI show a significant improvement (Pager et al. 2002). Some studies have shown that PFME plus biofeedback (Allgayer et al. 2005) or PFME plus biofeedback and rectal balloon training (Kim et al. 2011) are effective treatments for FI after LAR. However, Norton and Cody (2012) have conducted a systemic review, showing that there is insufficient evidence as to whether there is a difference in outcome between biofeedback and exercise alone on FI. Because of the requirement for rectal balloon training or biofeedback of placing a balloon or pressure device into the anus of the patient by the research assistant, we did not perform these techniques. Additionally, few empirical studies have examined the effects of PFME on FI in CRC patients after stoma closure in Taiwan. Therefore, it is important to develop a better understanding of the effects of PFME on FI caused by surgery in CRC patients. 450
A I MS The aims of this study were to explore the FI statuses and to examine the effects of PFME on FI in CRC patients following stoma closure. ME THODS Hypotheses Two hypotheses were tested in this study as follows: H1 – The degree of FI would decrease with time after stoma closure in all participants. H2 – Participants in the PFME group would have a greater reduction in FI compared with participants in the non-exercise group. Design This study applied an experimental and longitudinal study design with one pre-test and five post-tests. Before the intervention started, all participants received 1 h of education about rectum anatomy and physiology, the LAR procedure, the stoma closure procedure and the relationship between the LAR procedure and FI. Baseline data were collected, and then PFME was taught by a research assistant the day before patient discharge (baseline, Time 0) from the hospital. We also collected data and followed up with patients at 1 (Time 1), 2 (Time 2), 3 (Time 3), 6 (Time 6) and 9 (Time 9) months after discharge. Educated patients were allowed to complete the CCI by themselves, whereas the research assistant read the CCI questions to uneducated patients and assisted them in choosing their responses. If subjects were unable to meet the research assistant at the clinic, they responded over the telephone. Setting and samples Sample size was estimated from a pilot study (n = 10 for each group). G*Power 3.1.2 software was used to estimate the sample size (Faul et al. 2007). We used the repeated measures statistical test to determine the third month FI mean score {exercise group mean = 3.05 [n = 10, standard deviation (SD) = 2.01] and non-exercise group mean = 7.53 (n = 10, SD = 5.12)] for each group to conduct power analysis from the pilot study. The effect size value was 0.58, and the power was set to 0.95 with an alpha of 0.05. Therefore, the estimated sample size for this study was n = 26 per group. Considering the dropout rate, n = 30 participants needed to be recruited for each group. Following approval by the human subject protection committee, 60 patients were recruited from a 1264-bed © 2015 John Wiley & Sons Ltd
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hospital in southern Taiwan. Inclusion criteria for participants included: (1) 20 years of age or older; (2) underwent stoma closure for rectal cancer; and (3) the ability to communicate in Mandarin or Taiwanese. Exclusion criteria for participants included those older than 80 years of age and/or a history of previous pelvic floor surgery. Participants were randomly assigned to the exercise group (who were taught PFME and given an exercise DVD and pamphlet) or the non-exercise group (who were only given a pamphlet) according to the receipt of an odd- or evennumbered ticket in a sealed envelope. When a potential participant was diagnosed with rectal cancer and admitted for conventional LAR with temporary ileostomy, the research assistant invited a nurse on the ward to draw a sealed envelope from a box containing 60 sealed envelopes, with priority given according to admission date. Those with even-numbered tickets were placed into the exercise group, and those with odd-numbered tickets were placed into the non-exercise group. After patients were discharged from the hospital, the research assistant and case manager confirmed the date of stoma closure, after the physician determined the date of surgery for the patient.
IN T E R V E N T I O N Baseline data were collected the day before discharge from the hospital, and then PFME was taught. The outcomes were examined again at 1-, 2-, 3-, 6- and 9-month intervals after the PFME intervention to determine whether significant results were achieved compared with the control group. The PFME training protocol was developed in prior studies conducted by the first author (Lin et al. 2011, 2012). Pelvic floor muscle training exercises were defined as a series of exercises designed to strengthen the muscles of the pelvic floor. The PFME training protocol in this study required participants in the exercise group to perform PFME (20 PFM contractions and relaxations four times per day) as part of their regular daily activities, and they were double checked by the first author and research assistant to ensure that were contracting the proper pelvic floor muscles (and not contracting the gluteal muscles, hip adductor, or abdominal muscles) when the exercises were first taught (the day before patient discharge) and again at the second visit (1 week after discharge). The exercise group was also given a PFME DVD as a reminder of how to perform the exercises. Because our patients had an anastomosis wound located around the anus, it would have been unacceptable to perform rectal balloon training or biofeedback because of the requirement for putting a © 2015 John Wiley & Sons Ltd
balloon or pressure device into the anus by the research assistant; therefore, PFME alone was used in this study. The non-exercise group was not taught any exercises and did not receive a DVD. All participants in the two groups received a pamphlet for post-surgical care. To track compliance with PFME, the research assistant used a script to call the exercise group participants by telephone (every week for the first month) and discuss any problems they faced when performing the exercises. To provide standard care for the control group, the research assistant called the nonexercise participants and discussed issues such as food avoidance or preference and wound care, as well as their healing progress after discharge. Instrument 1: Faecal incontinence We assessed participants’ FI using the Cleveland Clinic Faecal Incontinence Symptom Severity Scoring System (CCI) developed by Wexner (Jorge & Wexner 1993; The Cleveland Clinic Foundation 2005), which is also called the Wexner scale. The CCI score considers the frequency of incontinence and the extent to which it alters a person’s life. It includes five questions assessing the type of incontinence (e.g., solid, liquid, gas, necessity for wearing a pad and lifestyle alterations) and the frequency of each type of incontinence, rated on a scale ranging from 0 (never) to 4 (daily). The sum of the frequencies is added to yield a total score that can range from 0 to 20. A score of 0 means perfect control, scores with a range of 1–7 correlate with little incontinence, 8–14 with moderate incontinence, 15–19 with severe incontinence and a score of 20 indicates complete incontinence, with higher scores indicating higher levels of FI (Jorge & Wexner 1993). The reliability analyses showed good internal consistency, with an alpha value of 0.91. 2: Personal characteristics and disease-related variables The following demographic items were added to the questionnaire: age, marital status, education level and employment status. The following disease-related variables were also included: body mass index [BMI, calculated as weight (Kg)/height (m2)], cancer stage, frequency of defecation and interval between LAR and stoma closure. Ethical aspects This study was approved by the participant hospital’s institutional review board (EMRP-098-134). A written 451
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consent form was signed by all of the participants, and they were informed that there were no physical, social or legal risks involved in the study and that their participation was voluntary.
Characteristics of participants A total of 60 patients underwent stoma closure. However, six patients refused to participate in the study after undergoing this procedure (exercise = three patients and nonexercise = three patients) because of personal privacy and family refusal. In addition, one non-exercise group participant died during the third month of follow-up. A total of 53 participants (exercise group n = 27 and non-exercise group n = 26) completed the 9-month study (retention rate of 88.3%) (Fig. 1). Data were collected from November 2010 to March 2014. A summary of the demographic characteristics of the study participants is presented in Table 1. A total of 53 participants completed the study, including 27 in the exercise group and 26 in the non-exercise group. The mean age of the sample was 64.1 years (SD = 12.6 years), with a
Statistical analysis Statistical analysis was performed using Statistical Package for the Social Sciences (SPSS™), version 17.0 (SPSS, Chicago, IL, USA). Values were expressed as frequencies, percentages, means and SDs. The chi-square test was used to compare differences in the demographic variables and disease-related variables between the exercise and non-exercise groups at baseline. Finally, a mixed model for generalised estimation equations (GEEs) was used in repeated measurement analysis of patients’ FI changes at each time point. The differences between the groups at each time point were identified.
Total 60 patients stoma closure procedure
Experimental Group: 30
Control group: 30
Refuse: 3 --Family refuse 3
Refuse: 3 --For privacy 1 -- Family refuse 2
1. Collected baseline data 2. PFME taught 3. Given DVD and Pamphlet of post-surgical care
Given Pamphlet of post-surgical Agree 27
Agree 27
care (the day before discharge)
Intervention time: the day before discharge
Follow up (n = 27)
Follow up (n = 27) 1 Expired at the third month
1, 2, 3, 6, 9 months (n = 27)
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1, 2, 3, 6, 9 months (n = 26)
Figure 1. Flow diagram for participant participation. PMFE, pelvic floor muscle exercise.
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Table 1. Baseline demographics and disease-related data of participants (n = 53) Exercise group (n = 27), n (%)
Non-exercise group (n = 26), n (%)
χ2
P value
0.46 – – –
.498 – – .039
– – – 0.15 – – 3.62 – – 0.16 – – 0.15 – – 0.18 – –
.704 – – .782 – – .057 – – .691 – – .695 – – .669 – –
2.42 – –
.119 – –
Interval between LAR and stoma closure Range: 2–18 Median = 4 months Mean = 5.3 (SD = 3.7) ≤4 months (32, 60.4) 16 (59.3) 16 (61.5) >4 months (21, 39.6) 11 (40.7) 10 (19.2)
0.29
.865
– –
– –
Frequency of defecation Range: 1–20 Mean = 6.4 (SD = 6.0) Mode = 15 ≤3 (26, 59.6) 15 (55.6) >3 (27, 40.4) 12 (44.4) Cancer staging – I (15, 28.3) 9 (33.3) II (22, 41.5) 10 (37.5) III (12, 22.6) 7 (25.9) IV (4, 7.5) 1 (3.7) Height of anastomosis – ≤5 cm 11 (40.7) >5 cm 16 (59.3) Mesorectal excision – Total 17 (63.0) Partial 10 (37.0) Pre-RT – Yes 3 (11.1) No 24 (88.9)
0.69 – – – – – – – 0.46 – – 0.15 – – – – –
.405 – – .553 – – – – .498 – – .695 – – .330 – –
Variables (n, %)
Age range: 27–79 Mean = 64.1 years (SD = 12.6) .05), indicating that their baseline FI levels were similar. The mean CCI scores from Time 1 to Time 6 were significantly different between the two groups (all P < .05), but the mean CCI scores of the two groups were not significantly different at Time 9 (P > .05). These results indicate that the PFME group’s FI levels improved more than those of the non-exercise group during the first 6 months after stoma closure but that the two groups’ mean FI scores were similar at 9 months. After controlling for gender, the GEE tests indicated no interaction between the groups and test times (Z = 10.37, P = .065). Significant differences in FI were observed for both group (Z = 5.77, P = .016) and time (Z = 41.43, P < .001). Table 4 shows that PFME was effective in
DISCUSSION Hypothesis 1 The first hypothesis stated that the degree of FI would decrease with time after stoma closure in all participants. This study’s findings support the hypothesis, indicating that 58.4% of the participants experienced moderate to severe FI before hospital discharge, and FI decreased each month from the first month to the ninth month (39.6% to 5.7% respectively). The percentages of those with FI during the first 6 months of this study were within the
Table 2. CCI scores of patients over time (n = 53) FI score range
Baseline n (%)
Time 1 n (%)
Time 2 n (%)
Time3 n (%)
Time 6 n (%)
Time 9 n (%)
0 (Continence) 1–7 (Little FI) 8–14 (Moderate FI) 15–19 (Severe FI) 20 (Complete FI) Mean (SD)
0 22 (41.5) 27 (50.9) 4 (7.5) 0 8.45 (3.5)
3 (5.7) 29 (54.7) 16 (30.2) 5 (9.4) 0 6.7 (4.8)
3 (9.4) 33 (62.3) 16 (30.2) 1 (1.9) 0 5.9 (3.8)
5 (9.4) 36 (67.9) 12 (22.6) 0 0 4.7 (3.6)
7 (13.2) 40 (75.5) 6 (11.3) 0 0 3.6 (2.9)
13 (24.5) 37 (69.8) 3 (5.7) 0 0 2.5 (2.3)
Baseline: Before discharge; Time 1: 1 month after discharge; Time 2: 2 months after discharge; Time 3: 3 months after discharge; Time 6: 6 months after discharge; and Time 9: 9 months after discharge. CCI, Cleveland Clinic Faecal Incontinence; FI, faecal incontinence; SD, standard deviation. Table 3. Mean CCI scores at baseline and 1, 2, 3, 6 and 9 months for the two groups (n = 53) Time
Exercise group M (SD)
Non-exercise group M (SD)
Test (t/Z)
P value
FI scores Baseline (T0) 1 Month (T1) 2 Months (T2) 3 Months (T3) 6 Months (T6) 9 Months (T9)
8.37 5.33 4.67 3.30 2.67 2.27
8.54 8.12 7.19 6.19 4.54 2.58
−.170* −1.97† −2.33† −2.74† −2.36† −0.37†
.886 .048 .020 .006 .023 .711
(3.54) (4.28) (2.76) (2.40) (1.88) (5.13)
(3.58) (4.99) (4.25) (4.03) (3.59) (7.55)
*t-Test (t). †Mann–Whitney U-test (Z). CCI, Cleveland Clinic Faecal Incontinence; FI, faecal incontinence; SD, standard deviation.
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Table 4. CCI scores over time for the two groups (n = 53) Parameter
Regression coefficient
SE
Z
P value
95% CI
Intercept Pre-test (exercise/non-exercise group) Difference of group (T1/baseline) Difference of group (T2/baseline) Difference of group (T3/baseline) Difference of group (T6/baseline) Difference of group (T9/baseline) Interaction of T1 and group Interaction of T2 and group Interaction of T3 and group Interaction of T6 and group Interaction of T9 and group
2.58 −0.21 5.96 5.54 4.62 3.62 1.96 −0.04 −2.58 −2.32 −2.69 −1.67
0.45 0.63 0.74 0.86 0.72 0.58 0.46 1.03 1.27 0.89 0.84 0.68
32.92 0.11 64.76 41.43 41.60 38.92 17.94 0.01 4.09 6.75 10.34 5.91
.000 .741 .000 .000 .000 .000 .000 .970 .043 .009 .001 .015
1.70 ∼ 3.46 −1.43 ∼ 1.02 4.51 ∼ 7.41 3.85 ∼ 7.23 3.21 ∼ 6.02 2.47 ∼ 4.76 1.05 ∼ 2.87 −1.99 ∼ 2.07 −5.07 ∼ −0.08 −4.07 ∼ −0.57 −4.33 ∼ −1.05 −3.01 ∼ −0.32
Dependent variable: Cleveland Clinic Faecal Incontinence (CCI score). Controlled for gender, P > .05. Interaction of T1, 2, 3, 6, 9 and group: differences between exercise group and non-exercise group at all-time points. Equation used: Y = 2.58 − 0.21 × group + 5.96 × (T1/baseline) + 5.54 × (T2/baseline) + 4.62 × (T3/baseline) + 3.62 × (T6/baseline) + 1.96 × (T9/baseline) − 0.04 × (interaction of T1 and group) − 2.58 × (interaction of T2 and group) − 2.31 × (interaction of T3 and group) − 2.69 × (interaction of T6 and group) − 1.67 × (interaction of T9 and group). CI, confidence interval; SD, standard deviation; SE, standard error.
range reported by previous studies (10–85%) (Yu & Dai 2004; Ko et al. 2008). Patients had various degrees of FI symptoms after stoma closure, and these faecal changes lasted three or more months after surgery. The results showed that the participants’ FI improved (Table 4) and revealed that time had a significant effect on FI (P < .001), indicating that FI decreased over time across both groups. FI decreased significantly in all patients after stoma closure, regardless of the exercise intervention. These results indicate that participants’ faecal continence was better than that reported in previous studies (Vironen et al. 2006; Varpe et al. 2011). Previous studies have reported that major bowel dysfunctions (urgency, frequency and incontinence) occur in 30–70% of patients at 1 year after rectal operative procedures. Defecation changes after surgery are related to the LAR procedure, after which the patients’ anal canal sensation is reduced within 3 months but is improved by approximately 12 months after surgery (Yamada et al. 2007).
Hypothesis 2 Our second hypothesis stated that participants in the PFME group would have a greater faecal continence rate compared with those in the non-exercise group. Some studies have demonstrated that PFME can increase the strength of pelvic floor muscles (Parekh et al. 2003; Filocamo et al. 2005; Song et al. 2007). After 6 months of PFME, a statistically significant improvement was found in the exercise group (P < .05) (Table 3) in this study, which is consistent with findings from previous studies (Pager et al. 2002; Shamliyan et al. 2007). However, this © 2015 John Wiley & Sons Ltd
study differed from previous studies because it used PFME alone. Pager et al. (2002) have also found that after 4 months of PFME and biofeedback treatment for patients with FI (not rectal cancer patients who had FI after stoma closure), 75% had significant FI improvement. In a study conducted by Laforest et al. (2012), the efficacy of anal sphincter training (PFME was used with biofeedback) in 22 patients who received LAR and underwent stoma closure was explored. The authors found that this training could effectively reduce the degree of FI. These results are congruent with those of the present study, although PFME was performed without biofeedback in this study. Some previous studies have reported that FI improves at 12 months after stoma closure (Yamada et al. 2007; Tokoro et al. 2013). However, our study revealed that it significantly improved at 9 months in both groups. This outcome may be due to the tissue recovery and remodelling phase, which starts at the third week and lasts up to 12 months (Ward 2013). The greater the degree of injured tissue, the more time it takes for recovery. Patients in the exercise group recovered faster than those in the nonexercise group with regard to FI, indicating that the anal tissue of the patients in the exercise group recovered faster than that of the non-exercise group patients. There is limited knowledge of the optimal timing for starting PFME training. In this study, we recognised patients who received LAR with temporary stoma and allowed for several months to arrange the date of the stoma closure procedure. During this period, patients defecated mainly by the stoma. Further studies are needed to determine the optimal time to begin PFME training that compare its effects pre- and post-stoma closure. 455
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We examined the effect sizes of the mean CCI scores at 1, 2, 3 and 6 months for the two groups to conduct power analysis for re-testing whether the sample size was appropriate. The results showed that when we the power was set to 0.80 and the alpha was 0.05, the effect sizes were 0.30, 0.35, 0.44 and 0.32 respectively (moderate effect sizes) (Cohen 1992). These effect sizes were used to re-calculate the total sample sizes, which were 58, 50, 34 and 58 from Time 1 to Time 6. These findings also demonstrated that the sample size of this study was appropriate. Our findings with regard to sample size provide a foundation for further research.
Limitations of this study and recommendations for future research There are some limitations of this study. First, we only recruited patients from a hospital in southern Taiwan, which may have limited the ability to generalise the results of this study to other populations. Second, the randomisation process using sealed envelopes for each patient may have limited the experimental design because we could not guarantee the sample size of final analysis due to attrition. Third, a previous study has suggested that anorectal manometry is an adequate method to evaluate anal sphincter muscle pressure, sensation in the rectum and the neural reflexes that are needed for normal bowel movements and that rectal balloon training or biofeedback in addition to PFME is more effective for treating FI. However, in this study, the site of the operation for most participants was the anus; thus, examining anal pressure by putting a balloon or pressure device into the anus would have been unacceptable. Patients from Eastern countries and their family members typically refuse to undergo any invasive procedure that is still in the experimental stage or in clinical trials. Hence, the assessment of
R EF E R E N C E S Allgayer H., Dietrich C.F., Rohde W., Koch G.F. & Tuschhoff T. (2005) Prospective comparison of short- and long-term effects of pelvic floor exercise/biofeedback training in patients with fecal incontinence after surgery plus irradiation versus surgery alone for colorectal cancer: clinical, functional and endoscopic/ endosonographic findings. Scandinavian Journal of Gastroenterology 40, 1168– 1175. Alsheik E.H., Coyne T., Hawes S.K., Merikhi L., Naples S.P., Kanagarajan N., Reynolds J.C., Myers S.E. & Ahmad A.S. (2012) Fecal incontinence: prevalence,
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an invasive procedure was not feasible for this Eastern conservative population. Researchers should not allow participants to suffer unnecessary harm and should also respect their autonomy and cultural diversity. Other notable issues exist; for example, a previous study has revealed that FI differs during the day and night (Ko et al. 2008). In addition, the LARS score was recently presented as a validated scoring system of urgency, frequency and clustering besides the CCI score with a special emphasis on quality of life (Emmertsen & Laurberg 2012), which we did not take into account in our study. Thus, further studies are recommended. Additionally, this study only followed-up functional outcome changes for 9 months, and further studies may be performed to assess long-term outcomes after surgery.
C ONC L USI ON This study has demonstrated that PFME may have a positive short-term effect on FI in rectal cancer patients after stoma closure. Our results may encourage health-care providers to include this intervention in patients’ discharge plans. This study is relevant not only for nurses, but also for other members of the health-care team because treatment options for FI involve several disciplines, including nursing and physical therapy.
A C KNOWL E DGE ME NTS Funding for this study was received from the National Science Council (NSC) of Taiwan (NSC 99-2314-B-214007-MY3). The investigators conducted the study independently; the content is solely the responsibility of the authors and does not necessarily represent the official views of the NSC. The authors declare no conflicts of interest.
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prevalence and role of dietary fiber intake. American Journal of Obstetrics and Gynecology 200, 566.e1–566.e6. Ministry of Health and Welfare (2013) 2012 Taiwan Top Ten Mortality Rate Statistic. Available at: http://www.mohw.gov.tw/ cht/DOS/Statistic.aspx?f_list_no=312 &fod_list_no=2747 Norton C. & Cody J.D. (2012) Biofeedback and/or sphincter exercises for the treatment of faecal incontinence in adults. Cochrane Database of Systematic Reviews (7), CD002111, doi: 10.1002/ 14651858.CD002111.pub3 Norton C., Chelvanayagam S., WilsonBarnett J., Redfern S. & Kamm M.A. (2003) Randomized controlled trial of biofeedback for fecal incontinence. Gastroenterology 125, 1320–1329. Nygaard I., Barber M.D., Burgio K.L., Kenton K., Meikle S., Schaffer J., Spino C., Whitehead W.E., Wu J. & Brody D.J. (2008) Prevalence of symptomatic pelvic floor disorders in US women. Journal of the American Medical Association 300, 1311–1316. Pager C.K., Solomon M.J., Rex J. & Roberts R.A. (2002) Long-term outcomes of pelvic floor exercise and biofeedback treatment for patients with fecal incontinence. Disease of the Colon and Rectum 45, 997–1003. Parekh A.R., Feng M.I., Kirages D., Bremner H., Kaswick J. & Aboseif S. (2003) The role of pelvic floor exercises on postprostatectomy incontinence. Journal of Urology 170, 130–133. Rao S.S.C. (2004) Practice Guideline: Diagnosis and management of fecal incontinence. American Journal of Gastroenterology 99, 1585–1604. doi: 10.1111/j.1572-0241.2004.40105.x; Available at: http://s3.gi.org/physicians/ guidelines/FecalIncontinence.pdf Rieger N.A., Wattchow D.A., Sarre R.G., Cooper S.J., Rich C.A., Saccone G.T., Schloithe A.C., Toouli J. & McCall J.L. (1997) Prospective trial of pelvic floor retaining in patients with fecal incontinence. Disease of the Colon and Rectum 40, 821–826. Shamliyan T., Wyman J., Bliss D.Z., Kane R.L. & Wilt T.J. (2007) Prevention of urinary and fecal incontinence in adults. Evidence Report/Technology Assessment 161, 1–379. Siegel R., Naishadham D. & Jemal A. (2013) Cancer statistics, 2013. CA:
A Cancer Journal for Clinicians 63, 11–30. Song C., Doo C.K., Hong J.H., Choo M.S., Kim C. & Ahn H. (2007) Relationship between the integrity of the pelvic floor muscles and early recovery of continence after radical prostatectomy. Journal of Urology 178, 208–211. The Cleveland Clinic Foundation (2005) The Structure and Function of the Digestive System. Available at: http:// www.cchs.net/health/health-info/docs/ 1600/1699.asp?index=7041 Tokoro T., Okuno K., Hida J.I., Ueda K., Yoshifuji T., Daito K., Takemoto M. & Sugiura F. (2013) Analysis of the clinical factors associated with anal function after intersphincteric resection for very low rectal cancer. World Journal of Surgical Oncology 11, 24. doi:10.1186/ 1477-7819-11-24; Available at: http:// www.wjso.com/content/11/1/24 Varpe P., Huhtinen H., Rantala A., Salminen P., Rautava P., Hurme S. & Grönroos J. (2011) Quality of life after surgery for rectal cancer with special reference to pelvic floor dysfunction. Colorectal Disease 13, 399–405. Vironen J.H., Kairaluoma M., Aalto A.M. & Kellokumpu J.H. (2006) Impact of functional results on quality of life after rectal cancer surgery. Disease of the Colon and Rectum 49, 568–578. Visser W.S., Te Riele W.W., Boerma D., van Ramshorst B. & van Westreenen H.L. (2014) Pelvic floor rehabilitation to improve functional outcome after a low anterior resection: a systematic review. Annals of Coloproctology 30, 109–114. Ward P. (2013) Soft Tissue Therapy and Recovery. Optimum Sport Performance. Available at: http://optimumsports performance.com/blog/category/soft -tissue-therapy-and-recovery/ Yamada K., Ogata S., Saiki Y., Fukunaga M., Tsuji Y. & Takano M. (2007) Functional results of intersphincteric resection for low rectal cancer. British Journal of Surgery 94, 1272–1277. Yu P.J. & Dai Y.T. (2004) The anal incontinence of rectal cancer patients who received lower anterior resection and effect of biofeedback training program. Research reported from National Science Council. Available at: http://ntur.lib.ntu .edu.tw/bitstream/246246/28512/1/ 922314B002277.pdf
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Effects of pelvic floor muscle exercise on faecal incontinence in rectal cancer patients after stoma closure Y.-H. LIN, RN, PHD, PROFESSOR, Department of Nursing, I-Shou University, Kaohsiung, H.-Y. YANG, RN, PHD, ASSISTANT PROFESSOR, Department of Nursing, Mackay Medical College, Taipei, S.-L. HUNG, RN, PHD, ASSISTANT PROFESSOR, Department of Nursing, National Tainan Junior College of Nursing, Tainan, H.-P. CHEN, BSC, PHYSICIAN, Division of Colon and Rectal Surgery, Department of Surgery, E-DA Hospital, Kaohsiung, K.-W. LIU, BSC, PHYSICIAN, Division of Colon and Rectal Surgery, Department of Surgery, E-DA Hospital, Kaohsiung, T.-B. CHEN, PHD, ASSOCIATE PROFESSOR, Department of Medical Imaging and Radiological Science, I-Shou University, Kaohsiung, & S.-C. CHI, RN, MSN, DEAN,
Nursing Department, E-DA Hospital, Kaohsiung, Taiwan LIN Y.-H., YANG H.-Y., HUNG S.-L., CHEN H.-P., LIU K.-W., CHEN T.-B. & CHI S.-C. (2016) European Journal of Cancer Care 25, 449–457 Effects of pelvic floor muscle exercise on faecal incontinence in rectal cancer patients after stoma closure The purpose of this study was to examine the effects of pelvic floor muscle exercise (PFME) on the faecal incontinence (FI) of rectal cancer patients following stoma closure. Participants were randomly distributed into an exercise group (n = 27) and non-exercise group (n = 26). An experimental design and longitudinal approach were implemented for data collection. Baseline data were collected at 1 day before discharge, and then PFME was taught before the patients were discharged from the hospital. We collected data and followed up with the patients at their pre-discharge visit and at 1, 2, 3, 6 and 9 months after discharge. The Cleveland Clinic Faecal Incontinence (CCI) score was used to measure patient outcome. PFME proved to effectively decrease the degree of FI in stoma closure recipients. The FI score of the exercise group significantly decreased from 8.37 to 2.27 after PFME compared with that of the non-exercise group (from 8.54 to 2.58). The generalised estimation equation tests showed that both group and time were significantly different. The tests also indicated that although PFME appeared to hasten the decline of incontinence, this effect was no longer detectable at 9 months; thus, it may be an effective intervention for FI when implemented up to half a year after discharge.
Keywords: faecal incontinence, pelvic floor muscle exercise, rectal cancer, stoma closure.
IN T R O D U C T I O N Colorectal cancer (CRC) comprised the most new cases of any type of cancer and was the third leading cause of cancer-related deaths in Taiwan from 2001 to 2012
Correspondence address: Yu-Hua Lin, Department of Nursing, I-Shou University, No. 8, Yida Road., Yanchao District, Kaohsiung 82445, Taiwan (R.O.C.) (e-mail: [email protected]; [email protected]). Ethical approval: Ethical approval was obtained from participants’ hospital institutional review boards.
Accepted 6 January 2015 DOI: 10.1111/ecc.12292 European Journal of Cancer Care, 2016, 25, 449–457
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(Ministry of Health and Welfare 2013). CRC ranked third in most new cases and most cancer deaths in the United States, with an estimated 142 820 new cases and 50 830 deaths in 2013 (Siegel et al. 2013). For cancers located in the sigmoid colon (close with rectum junction) and rectum (especially the lower rectum), lower anterior resection (LAR) is considered to be the optimal treatment. However, some patients may need a temporary stoma for defecation for several months after the procedure (Lin 2009; Tokoro et al. 2013). It takes approximately three or more months after surgery for the anal tissues of patients to recover, at which point the stoma is usually closed, and the patient regains
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normal anal defecation (Ko et al. 2008). However, due to surgical damage of the anal sphincter and its associated nerves (Chatwin et al. 2002), 30–70% of patients experience bowel dysfunction, including stool frequency, faecal urgency, diarrhoea and faecal incontinence (FI) (Rao 2004; Vironen et al. 2006; Varpe et al. 2011). These symptoms affect patients’ daily activities, work and quality of life (Norton et al. 2003; Mahony et al. 2004; Yu & Dai 2004; Liou & Chen 2008; Lin 2009; Markland et al. 2009). Faecal incontinence is defined as the inadvertent passage of stool, soiling or excessive flatulence (Nygaard et al. 2008; Markland et al. 2009; Alsheik et al. 2012). Previous studies have found that 10–85% of patients have varying degrees of FI symptoms after stoma closure, and these faecal changes last from 3 months to 1 year after surgery (Yu & Dai 2004; Ko et al. 2008). Clearly, FI affects patients’ lives and is a source of embarrassment for them. The fear of such episodes may limit patients’ activities and carry social stigma (Rao 2004; Varpe et al. 2011). Although the impact of FI on LAR recipients has been well documented, reports in the literature on FI and interventions for improvement are still sparse in Taiwan. It is important to understand the changes that can occur as a result of LAR, including the degrees of increased FI. As an intervention, some studies have reported that pelvic floor muscle exercise (PFME) can resolve FI (Shamliyan et al. 2007). Visser et al. (2014) have conducted a systematic review, finding that PFME is a useful rehabilitation technique for improving FI after LAR and should be considered as the initial treatment for patients with FI (Rieger et al. 1997). One study has revealed that after 4 months of PFME and biofeedback treatment, 75% of patients with FI show a significant improvement (Pager et al. 2002). Some studies have shown that PFME plus biofeedback (Allgayer et al. 2005) or PFME plus biofeedback and rectal balloon training (Kim et al. 2011) are effective treatments for FI after LAR. However, Norton and Cody (2012) have conducted a systemic review, showing that there is insufficient evidence as to whether there is a difference in outcome between biofeedback and exercise alone on FI. Because of the requirement for rectal balloon training or biofeedback of placing a balloon or pressure device into the anus of the patient by the research assistant, we did not perform these techniques. Additionally, few empirical studies have examined the effects of PFME on FI in CRC patients after stoma closure in Taiwan. Therefore, it is important to develop a better understanding of the effects of PFME on FI caused by surgery in CRC patients. 450
A I MS The aims of this study were to explore the FI statuses and to examine the effects of PFME on FI in CRC patients following stoma closure. ME THODS Hypotheses Two hypotheses were tested in this study as follows: H1 – The degree of FI would decrease with time after stoma closure in all participants. H2 – Participants in the PFME group would have a greater reduction in FI compared with participants in the non-exercise group. Design This study applied an experimental and longitudinal study design with one pre-test and five post-tests. Before the intervention started, all participants received 1 h of education about rectum anatomy and physiology, the LAR procedure, the stoma closure procedure and the relationship between the LAR procedure and FI. Baseline data were collected, and then PFME was taught by a research assistant the day before patient discharge (baseline, Time 0) from the hospital. We also collected data and followed up with patients at 1 (Time 1), 2 (Time 2), 3 (Time 3), 6 (Time 6) and 9 (Time 9) months after discharge. Educated patients were allowed to complete the CCI by themselves, whereas the research assistant read the CCI questions to uneducated patients and assisted them in choosing their responses. If subjects were unable to meet the research assistant at the clinic, they responded over the telephone. Setting and samples Sample size was estimated from a pilot study (n = 10 for each group). G*Power 3.1.2 software was used to estimate the sample size (Faul et al. 2007). We used the repeated measures statistical test to determine the third month FI mean score {exercise group mean = 3.05 [n = 10, standard deviation (SD) = 2.01] and non-exercise group mean = 7.53 (n = 10, SD = 5.12)] for each group to conduct power analysis from the pilot study. The effect size value was 0.58, and the power was set to 0.95 with an alpha of 0.05. Therefore, the estimated sample size for this study was n = 26 per group. Considering the dropout rate, n = 30 participants needed to be recruited for each group. Following approval by the human subject protection committee, 60 patients were recruited from a 1264-bed © 2015 John Wiley & Sons Ltd
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hospital in southern Taiwan. Inclusion criteria for participants included: (1) 20 years of age or older; (2) underwent stoma closure for rectal cancer; and (3) the ability to communicate in Mandarin or Taiwanese. Exclusion criteria for participants included those older than 80 years of age and/or a history of previous pelvic floor surgery. Participants were randomly assigned to the exercise group (who were taught PFME and given an exercise DVD and pamphlet) or the non-exercise group (who were only given a pamphlet) according to the receipt of an odd- or evennumbered ticket in a sealed envelope. When a potential participant was diagnosed with rectal cancer and admitted for conventional LAR with temporary ileostomy, the research assistant invited a nurse on the ward to draw a sealed envelope from a box containing 60 sealed envelopes, with priority given according to admission date. Those with even-numbered tickets were placed into the exercise group, and those with odd-numbered tickets were placed into the non-exercise group. After patients were discharged from the hospital, the research assistant and case manager confirmed the date of stoma closure, after the physician determined the date of surgery for the patient.
IN T E R V E N T I O N Baseline data were collected the day before discharge from the hospital, and then PFME was taught. The outcomes were examined again at 1-, 2-, 3-, 6- and 9-month intervals after the PFME intervention to determine whether significant results were achieved compared with the control group. The PFME training protocol was developed in prior studies conducted by the first author (Lin et al. 2011, 2012). Pelvic floor muscle training exercises were defined as a series of exercises designed to strengthen the muscles of the pelvic floor. The PFME training protocol in this study required participants in the exercise group to perform PFME (20 PFM contractions and relaxations four times per day) as part of their regular daily activities, and they were double checked by the first author and research assistant to ensure that were contracting the proper pelvic floor muscles (and not contracting the gluteal muscles, hip adductor, or abdominal muscles) when the exercises were first taught (the day before patient discharge) and again at the second visit (1 week after discharge). The exercise group was also given a PFME DVD as a reminder of how to perform the exercises. Because our patients had an anastomosis wound located around the anus, it would have been unacceptable to perform rectal balloon training or biofeedback because of the requirement for putting a © 2015 John Wiley & Sons Ltd
balloon or pressure device into the anus by the research assistant; therefore, PFME alone was used in this study. The non-exercise group was not taught any exercises and did not receive a DVD. All participants in the two groups received a pamphlet for post-surgical care. To track compliance with PFME, the research assistant used a script to call the exercise group participants by telephone (every week for the first month) and discuss any problems they faced when performing the exercises. To provide standard care for the control group, the research assistant called the nonexercise participants and discussed issues such as food avoidance or preference and wound care, as well as their healing progress after discharge. Instrument 1: Faecal incontinence We assessed participants’ FI using the Cleveland Clinic Faecal Incontinence Symptom Severity Scoring System (CCI) developed by Wexner (Jorge & Wexner 1993; The Cleveland Clinic Foundation 2005), which is also called the Wexner scale. The CCI score considers the frequency of incontinence and the extent to which it alters a person’s life. It includes five questions assessing the type of incontinence (e.g., solid, liquid, gas, necessity for wearing a pad and lifestyle alterations) and the frequency of each type of incontinence, rated on a scale ranging from 0 (never) to 4 (daily). The sum of the frequencies is added to yield a total score that can range from 0 to 20. A score of 0 means perfect control, scores with a range of 1–7 correlate with little incontinence, 8–14 with moderate incontinence, 15–19 with severe incontinence and a score of 20 indicates complete incontinence, with higher scores indicating higher levels of FI (Jorge & Wexner 1993). The reliability analyses showed good internal consistency, with an alpha value of 0.91. 2: Personal characteristics and disease-related variables The following demographic items were added to the questionnaire: age, marital status, education level and employment status. The following disease-related variables were also included: body mass index [BMI, calculated as weight (Kg)/height (m2)], cancer stage, frequency of defecation and interval between LAR and stoma closure. Ethical aspects This study was approved by the participant hospital’s institutional review board (EMRP-098-134). A written 451
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consent form was signed by all of the participants, and they were informed that there were no physical, social or legal risks involved in the study and that their participation was voluntary.
Characteristics of participants A total of 60 patients underwent stoma closure. However, six patients refused to participate in the study after undergoing this procedure (exercise = three patients and nonexercise = three patients) because of personal privacy and family refusal. In addition, one non-exercise group participant died during the third month of follow-up. A total of 53 participants (exercise group n = 27 and non-exercise group n = 26) completed the 9-month study (retention rate of 88.3%) (Fig. 1). Data were collected from November 2010 to March 2014. A summary of the demographic characteristics of the study participants is presented in Table 1. A total of 53 participants completed the study, including 27 in the exercise group and 26 in the non-exercise group. The mean age of the sample was 64.1 years (SD = 12.6 years), with a
Statistical analysis Statistical analysis was performed using Statistical Package for the Social Sciences (SPSS™), version 17.0 (SPSS, Chicago, IL, USA). Values were expressed as frequencies, percentages, means and SDs. The chi-square test was used to compare differences in the demographic variables and disease-related variables between the exercise and non-exercise groups at baseline. Finally, a mixed model for generalised estimation equations (GEEs) was used in repeated measurement analysis of patients’ FI changes at each time point. The differences between the groups at each time point were identified.
Total 60 patients stoma closure procedure
Experimental Group: 30
Control group: 30
Refuse: 3 --Family refuse 3
Refuse: 3 --For privacy 1 -- Family refuse 2
1. Collected baseline data 2. PFME taught 3. Given DVD and Pamphlet of post-surgical care
Given Pamphlet of post-surgical Agree 27
Agree 27
care (the day before discharge)
Intervention time: the day before discharge
Follow up (n = 27)
Follow up (n = 27) 1 Expired at the third month
1, 2, 3, 6, 9 months (n = 27)
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1, 2, 3, 6, 9 months (n = 26)
Figure 1. Flow diagram for participant participation. PMFE, pelvic floor muscle exercise.
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Table 1. Baseline demographics and disease-related data of participants (n = 53) Exercise group (n = 27), n (%)
Non-exercise group (n = 26), n (%)
χ2
P value
0.46 – – –
.498 – – .039
– – – 0.15 – – 3.62 – – 0.16 – – 0.15 – – 0.18 – –
.704 – – .782 – – .057 – – .691 – – .695 – – .669 – –
2.42 – –
.119 – –
Interval between LAR and stoma closure Range: 2–18 Median = 4 months Mean = 5.3 (SD = 3.7) ≤4 months (32, 60.4) 16 (59.3) 16 (61.5) >4 months (21, 39.6) 11 (40.7) 10 (19.2)
0.29
.865
– –
– –
Frequency of defecation Range: 1–20 Mean = 6.4 (SD = 6.0) Mode = 15 ≤3 (26, 59.6) 15 (55.6) >3 (27, 40.4) 12 (44.4) Cancer staging – I (15, 28.3) 9 (33.3) II (22, 41.5) 10 (37.5) III (12, 22.6) 7 (25.9) IV (4, 7.5) 1 (3.7) Height of anastomosis – ≤5 cm 11 (40.7) >5 cm 16 (59.3) Mesorectal excision – Total 17 (63.0) Partial 10 (37.0) Pre-RT – Yes 3 (11.1) No 24 (88.9)
0.69 – – – – – – – 0.46 – – 0.15 – – – – –
.405 – – .553 – – – – .498 – – .695 – – .330 – –
Variables (n, %)
Age range: 27–79 Mean = 64.1 years (SD = 12.6) .05), indicating that their baseline FI levels were similar. The mean CCI scores from Time 1 to Time 6 were significantly different between the two groups (all P < .05), but the mean CCI scores of the two groups were not significantly different at Time 9 (P > .05). These results indicate that the PFME group’s FI levels improved more than those of the non-exercise group during the first 6 months after stoma closure but that the two groups’ mean FI scores were similar at 9 months. After controlling for gender, the GEE tests indicated no interaction between the groups and test times (Z = 10.37, P = .065). Significant differences in FI were observed for both group (Z = 5.77, P = .016) and time (Z = 41.43, P < .001). Table 4 shows that PFME was effective in
DISCUSSION Hypothesis 1 The first hypothesis stated that the degree of FI would decrease with time after stoma closure in all participants. This study’s findings support the hypothesis, indicating that 58.4% of the participants experienced moderate to severe FI before hospital discharge, and FI decreased each month from the first month to the ninth month (39.6% to 5.7% respectively). The percentages of those with FI during the first 6 months of this study were within the
Table 2. CCI scores of patients over time (n = 53) FI score range
Baseline n (%)
Time 1 n (%)
Time 2 n (%)
Time3 n (%)
Time 6 n (%)
Time 9 n (%)
0 (Continence) 1–7 (Little FI) 8–14 (Moderate FI) 15–19 (Severe FI) 20 (Complete FI) Mean (SD)
0 22 (41.5) 27 (50.9) 4 (7.5) 0 8.45 (3.5)
3 (5.7) 29 (54.7) 16 (30.2) 5 (9.4) 0 6.7 (4.8)
3 (9.4) 33 (62.3) 16 (30.2) 1 (1.9) 0 5.9 (3.8)
5 (9.4) 36 (67.9) 12 (22.6) 0 0 4.7 (3.6)
7 (13.2) 40 (75.5) 6 (11.3) 0 0 3.6 (2.9)
13 (24.5) 37 (69.8) 3 (5.7) 0 0 2.5 (2.3)
Baseline: Before discharge; Time 1: 1 month after discharge; Time 2: 2 months after discharge; Time 3: 3 months after discharge; Time 6: 6 months after discharge; and Time 9: 9 months after discharge. CCI, Cleveland Clinic Faecal Incontinence; FI, faecal incontinence; SD, standard deviation. Table 3. Mean CCI scores at baseline and 1, 2, 3, 6 and 9 months for the two groups (n = 53) Time
Exercise group M (SD)
Non-exercise group M (SD)
Test (t/Z)
P value
FI scores Baseline (T0) 1 Month (T1) 2 Months (T2) 3 Months (T3) 6 Months (T6) 9 Months (T9)
8.37 5.33 4.67 3.30 2.67 2.27
8.54 8.12 7.19 6.19 4.54 2.58
−.170* −1.97† −2.33† −2.74† −2.36† −0.37†
.886 .048 .020 .006 .023 .711
(3.54) (4.28) (2.76) (2.40) (1.88) (5.13)
(3.58) (4.99) (4.25) (4.03) (3.59) (7.55)
*t-Test (t). †Mann–Whitney U-test (Z). CCI, Cleveland Clinic Faecal Incontinence; FI, faecal incontinence; SD, standard deviation.
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Table 4. CCI scores over time for the two groups (n = 53) Parameter
Regression coefficient
SE
Z
P value
95% CI
Intercept Pre-test (exercise/non-exercise group) Difference of group (T1/baseline) Difference of group (T2/baseline) Difference of group (T3/baseline) Difference of group (T6/baseline) Difference of group (T9/baseline) Interaction of T1 and group Interaction of T2 and group Interaction of T3 and group Interaction of T6 and group Interaction of T9 and group
2.58 −0.21 5.96 5.54 4.62 3.62 1.96 −0.04 −2.58 −2.32 −2.69 −1.67
0.45 0.63 0.74 0.86 0.72 0.58 0.46 1.03 1.27 0.89 0.84 0.68
32.92 0.11 64.76 41.43 41.60 38.92 17.94 0.01 4.09 6.75 10.34 5.91
.000 .741 .000 .000 .000 .000 .000 .970 .043 .009 .001 .015
1.70 ∼ 3.46 −1.43 ∼ 1.02 4.51 ∼ 7.41 3.85 ∼ 7.23 3.21 ∼ 6.02 2.47 ∼ 4.76 1.05 ∼ 2.87 −1.99 ∼ 2.07 −5.07 ∼ −0.08 −4.07 ∼ −0.57 −4.33 ∼ −1.05 −3.01 ∼ −0.32
Dependent variable: Cleveland Clinic Faecal Incontinence (CCI score). Controlled for gender, P > .05. Interaction of T1, 2, 3, 6, 9 and group: differences between exercise group and non-exercise group at all-time points. Equation used: Y = 2.58 − 0.21 × group + 5.96 × (T1/baseline) + 5.54 × (T2/baseline) + 4.62 × (T3/baseline) + 3.62 × (T6/baseline) + 1.96 × (T9/baseline) − 0.04 × (interaction of T1 and group) − 2.58 × (interaction of T2 and group) − 2.31 × (interaction of T3 and group) − 2.69 × (interaction of T6 and group) − 1.67 × (interaction of T9 and group). CI, confidence interval; SD, standard deviation; SE, standard error.
range reported by previous studies (10–85%) (Yu & Dai 2004; Ko et al. 2008). Patients had various degrees of FI symptoms after stoma closure, and these faecal changes lasted three or more months after surgery. The results showed that the participants’ FI improved (Table 4) and revealed that time had a significant effect on FI (P < .001), indicating that FI decreased over time across both groups. FI decreased significantly in all patients after stoma closure, regardless of the exercise intervention. These results indicate that participants’ faecal continence was better than that reported in previous studies (Vironen et al. 2006; Varpe et al. 2011). Previous studies have reported that major bowel dysfunctions (urgency, frequency and incontinence) occur in 30–70% of patients at 1 year after rectal operative procedures. Defecation changes after surgery are related to the LAR procedure, after which the patients’ anal canal sensation is reduced within 3 months but is improved by approximately 12 months after surgery (Yamada et al. 2007).
Hypothesis 2 Our second hypothesis stated that participants in the PFME group would have a greater faecal continence rate compared with those in the non-exercise group. Some studies have demonstrated that PFME can increase the strength of pelvic floor muscles (Parekh et al. 2003; Filocamo et al. 2005; Song et al. 2007). After 6 months of PFME, a statistically significant improvement was found in the exercise group (P < .05) (Table 3) in this study, which is consistent with findings from previous studies (Pager et al. 2002; Shamliyan et al. 2007). However, this © 2015 John Wiley & Sons Ltd
study differed from previous studies because it used PFME alone. Pager et al. (2002) have also found that after 4 months of PFME and biofeedback treatment for patients with FI (not rectal cancer patients who had FI after stoma closure), 75% had significant FI improvement. In a study conducted by Laforest et al. (2012), the efficacy of anal sphincter training (PFME was used with biofeedback) in 22 patients who received LAR and underwent stoma closure was explored. The authors found that this training could effectively reduce the degree of FI. These results are congruent with those of the present study, although PFME was performed without biofeedback in this study. Some previous studies have reported that FI improves at 12 months after stoma closure (Yamada et al. 2007; Tokoro et al. 2013). However, our study revealed that it significantly improved at 9 months in both groups. This outcome may be due to the tissue recovery and remodelling phase, which starts at the third week and lasts up to 12 months (Ward 2013). The greater the degree of injured tissue, the more time it takes for recovery. Patients in the exercise group recovered faster than those in the nonexercise group with regard to FI, indicating that the anal tissue of the patients in the exercise group recovered faster than that of the non-exercise group patients. There is limited knowledge of the optimal timing for starting PFME training. In this study, we recognised patients who received LAR with temporary stoma and allowed for several months to arrange the date of the stoma closure procedure. During this period, patients defecated mainly by the stoma. Further studies are needed to determine the optimal time to begin PFME training that compare its effects pre- and post-stoma closure. 455
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We examined the effect sizes of the mean CCI scores at 1, 2, 3 and 6 months for the two groups to conduct power analysis for re-testing whether the sample size was appropriate. The results showed that when we the power was set to 0.80 and the alpha was 0.05, the effect sizes were 0.30, 0.35, 0.44 and 0.32 respectively (moderate effect sizes) (Cohen 1992). These effect sizes were used to re-calculate the total sample sizes, which were 58, 50, 34 and 58 from Time 1 to Time 6. These findings also demonstrated that the sample size of this study was appropriate. Our findings with regard to sample size provide a foundation for further research.
Limitations of this study and recommendations for future research There are some limitations of this study. First, we only recruited patients from a hospital in southern Taiwan, which may have limited the ability to generalise the results of this study to other populations. Second, the randomisation process using sealed envelopes for each patient may have limited the experimental design because we could not guarantee the sample size of final analysis due to attrition. Third, a previous study has suggested that anorectal manometry is an adequate method to evaluate anal sphincter muscle pressure, sensation in the rectum and the neural reflexes that are needed for normal bowel movements and that rectal balloon training or biofeedback in addition to PFME is more effective for treating FI. However, in this study, the site of the operation for most participants was the anus; thus, examining anal pressure by putting a balloon or pressure device into the anus would have been unacceptable. Patients from Eastern countries and their family members typically refuse to undergo any invasive procedure that is still in the experimental stage or in clinical trials. Hence, the assessment of
R EF E R E N C E S Allgayer H., Dietrich C.F., Rohde W., Koch G.F. & Tuschhoff T. (2005) Prospective comparison of short- and long-term effects of pelvic floor exercise/biofeedback training in patients with fecal incontinence after surgery plus irradiation versus surgery alone for colorectal cancer: clinical, functional and endoscopic/ endosonographic findings. Scandinavian Journal of Gastroenterology 40, 1168– 1175. Alsheik E.H., Coyne T., Hawes S.K., Merikhi L., Naples S.P., Kanagarajan N., Reynolds J.C., Myers S.E. & Ahmad A.S. (2012) Fecal incontinence: prevalence,
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an invasive procedure was not feasible for this Eastern conservative population. Researchers should not allow participants to suffer unnecessary harm and should also respect their autonomy and cultural diversity. Other notable issues exist; for example, a previous study has revealed that FI differs during the day and night (Ko et al. 2008). In addition, the LARS score was recently presented as a validated scoring system of urgency, frequency and clustering besides the CCI score with a special emphasis on quality of life (Emmertsen & Laurberg 2012), which we did not take into account in our study. Thus, further studies are recommended. Additionally, this study only followed-up functional outcome changes for 9 months, and further studies may be performed to assess long-term outcomes after surgery.
C ONC L USI ON This study has demonstrated that PFME may have a positive short-term effect on FI in rectal cancer patients after stoma closure. Our results may encourage health-care providers to include this intervention in patients’ discharge plans. This study is relevant not only for nurses, but also for other members of the health-care team because treatment options for FI involve several disciplines, including nursing and physical therapy.
A C KNOWL E DGE ME NTS Funding for this study was received from the National Science Council (NSC) of Taiwan (NSC 99-2314-B-214007-MY3). The investigators conducted the study independently; the content is solely the responsibility of the authors and does not necessarily represent the official views of the NSC. The authors declare no conflicts of interest.
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