"Comparison of sexual function of people with colorectal cancer with and without colostomy bag in Tabriz hospitals 2022"

doi:10.21203/rs.3.rs-2240892/v1

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"Comparison of sexual function of people with colorectal cancer with and without colostomy bag in Tabriz hospitals 2022"

https://doi.org/10.21203/rs.3.rs-2240892/v1

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published 02 Aug, 2023

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Cancer is a family of diseases unique to multicellular organisms characterized by uncontrolled growth and proliferation of cells. Gastrointestinal Cancer is one of the most common cancers associated with high mortality. Colon and rectal cancer are among the most critical public health problems worldwide, so nearly one million new colon and rectal cancer cases are diagnosed every year, and nearly half of the cases die. In 1999, Laumann and his colleagues defined sexual dysfunction as a significant public health problem. Many people who have survived colorectal Cancer are sexually active. These people can have problems with their sexual performance due to reasons such as therapeutic surgeries, radiotherapy, or the presence of an ostomy.

This study is descriptive-comparative. To conduct the above study, 252 patients with colorectal Cancer were included in the study by a convenient method based on the inclusion criteria and after obtaining informed consent. The data collection tools included the demographic information form, the International Index of Erectile Function (IIEF), and the Women's Sexual Function Index (FSFI). The validity and reliability of these questionnaires have already been measured. Statistical analyzes were performed using IBM SPSS statistics version 24.

According to the results of statistical analysis, the IIEF total score for men with a colostomy is 26.17 ± 15.30 and without a colostomy, is 29.05 ± 17.14, as well as the total FSFI score for women with a colostomy, is 7.21 ± 6.40 and without a colostomy is 14.67 ± 9.10. There was no statistically significant difference in the sexual performance score of men with pouches compared to men without pouches (P > 0.05). The sexual performance score of women with bags compared to women without bags had a lower sexual performance score, which was statistically significant (P < 0.05). Therefore, an ostomy in women causes a drop in FSFI.

Health planners at the macro level and health service providers at the micro level should be aware of the importance of this issue and provide timely interventions to improve sexual performance and pay special attention to those aspects of FSFI that are of great importance.

Biological sciences/Cancer

Biological sciences/Psychology

Health sciences/Gastroenterology

Health sciences/Health care

Health sciences/Oncology

Cancer is a family of diseases unique to multicellular organisms characterized by uncontrolled growth and proliferation of cells(1). Cancer is a significant health problem worldwide and the second leading cause of death in the United States(2). About 30,000 people die from Cancer every year(3). According to the statistics published by the Institute of Evaluation and Health in 2015, in a survey of 32 cancers in 195 countries, between 2005 and 2015, the incidence of Cancer increased by 33% (4). Gastrointestinal Cancer is one of the most common cancers associated with high mortality. In Iran, gastrointestinal Cancer is considered one of the most common cancers, accounting for 38% of cancers and 44.4% of deaths (5, 6). Colon and rectal cancer are among the most critical public health problems worldwide, so nearly one million new colon and rectal cancer cases are diagnosed every year, and nearly half of the cases die(7). Rectal and colon cancer (CRC) is the subsequent and tertiary most common cause of cancer-related death in men and women in the United States, respectively(8). Colorectal cancer has significant effects on the health and economy of societies (9) in such a way that in one study, the cost of follow-up treatment for colon cancer is estimated at 2220 euros and for rectal Cancer at 4801 euros(10). Colorectal cancer and its treatments have symptoms such as weakness, tiredness, stupor, anorexia, nausea, vomiting, anemia, and nutritive conditions(11, 12). With outstanding treatment developments, the number of people with a history of Cancer is increasing. This consist of stayers alive with a permanent ostomy. An ostomy redirects body waste (feces and urine) to exit the intestine over a surgical opening in the abdomen(13, 14). More than 70 thousand people in England and almost 120 thousand people in the United States experience an ostomy annually(15, 16). The rate of prevalence of sexual problems in patients with prostate, female, and breast cancers is high (86–91%); this rate is also high in other cancers such as head and neck, blood, and colorectal cancers (53–79%)(17, 18). Many people who have survived colorectal Cancer are sexually active. These people can have problems with their sexual performance due to reasons such as therapeutic surgeries, radiotherapy, or the presence of an ostomy(19). Healthcare teams should discuss sexual function with their cancer patients and provide a simple solution(20). Community health nursing provides health services in a wide range of situations, including health promotion, disease prevention, health maintenance, reconstruction, coordination, management, and evaluation of care for individuals, families, and groups, including communities(21). Therefore, by conducting the above study, it is necessary to create a scientific background for the performance of community health nurses who provide care in the community. The current study is a descriptive-cross-sectional study designed to determine the level of sexual function in patients with colon and rectal cancer.

The target population of this research was patients with colon and rectal cancer, and the presence or absence of a bag and whether the bag was permanent or temporary was not taken into account during sampling. All of them used to go to centers providing outpatient chemotherapy services for chemotherapy. The method of sampling was available in the form of sampling. The researcher referred to the hospitals of Shahid Madani, Shahid Ghazi, Ali Nasab, Shahriar, and Valiasr in Tabriz and asked qualified and interested people to participate in the study to complete the project questionnaire. The method of conducting the present research was that the researcher, after obtaining permission from the vice president of research and technology and the research ethics committee of Tabriz University of Medical Sciences, went to the research environment, which was Tabriz hospitals, and after obtaining permission from the hospital managers, based on the method Sampling was the convenient method and then collected data. Data analysis was done using IBM SPSS Statistics version 24. In order to analyze the demographic information of the samples, the frequency and percentage were used. Also, due to the normality of the sexual function variable, descriptive statistics were used in the form of mean and standard deviation.

The normality criterion of the distribution of the variables was evaluated using the Kolmogorov-Smirnov test along with the Skewness and Kurtosis indices. The significance level of the test was considered 0.05 in this study. Also, the Chi-Square test was used to compare two groups when it was a qualitative variable and if the Cochrane conditions were met. If the Cochrane conditions were not met, the Chi-Square test was used based on Monte-Carlo Simulation to compare the two groups when the relevant variable was quantitative and with normal distribution. The independent sample t-test was used. It should be noted that for the comparison of demographic information, the chi-square test was used, and for the comparison of sexual function scores when quantitative comparison was made, the t-test of two independent groups was used and when the comparison was made. Qualitatively, the chi test was used. In order to control the effect of confounders, general linear modeling and multiple regression were used. It should be noted that the Ethics Committee approves the above research of Tabriz University of Medical Sciences with ID: IR.TBZMED.REC.1401.046 and All methods were performed in accordance with the relevant guidelines and regulations.

Entry criteria: definitive diagnosis of colon and rectal cancer by an oncologist; having a colostomy bag (permanent or temporary) in groups with male and female bags and not having a colostomy bag in groups without male and female bags; being married to the patient; being able to communicate; Willingness to participate in the study; Age over 30 years; referral for outpatient chemotherapy; Having the patient know about his illness and the type of treatment received; Being active in terms of sexual performance; Being active in terms of sexual function before the disease.

Exclusion criteria: suffering from other chronic and debilitating diseases (diabetes, kidney diseases, and any organ defects that can affect sexual function and health-related quality of life) according to the participant's statements; The presence of cognitive disorders in the person (such as Alzheimer's) according to the statements of the participant or his companions; known mental disorders according to the statement of the person himself or his companions or recorded in the file; Unwillingness to participate in the study.

Sample size and sampling method:

In this research, based on the findings related to the quality of life scores (SF-36), two groups of people with colorectal cancers with (74.1 ± 6.3) and without colostomy bag (80.3 ± 8.2) ) Näsvall et al.'s study(22) considering α = 0.05 power equal 0.9 and based on the formula of mean difference in two independent populations (\({\varvec{n}}^{\mathbf{*}}=\frac{{\left({\varvec{Z}}_{1-\varvec{\alpha }/2}+{\varvec{Z}}_{1-\varvec{\beta }}\right)}^{2}({\varvec{S}}_{1}^{2}+{\varvec{S}}_{2}^{2})}{{\varvec{d}}^{2}}\)); The required sample size was estimated to be 25 people. Considering the design effect coefficient equal to 2 (25*2=50) and 20 percent dropout(50/(1-0.2)) = 62.5), the sample size in each group will be 126 patients as follows:

1.63 female patients with a colostomy bag (female case group); 2 63 female patients without colostomy bag (female control group); 3 63 male patients with a colostomy bag (male case group); 4. 63 male patients without colostomy bag (male control group)

It should be noted that G-power software was used to calculate the sample volume(23).

Collection tools and methods: In this study, three tools are used as follows:

1. The data collection tool includes the demographic profile form: In this research, the personal-social profile of the participants who were questioned includes the following:

Age, gender, marital status, number of children, education, occupation, sufficient income, insurance coverage, duration of illness, place of residence, type of housing, level of education, type of treatment received, type of surgery performed, duration of chemotherapy last round, history of suffering from Cancer in distant and close relatives, the presence of cancer metastasis, the number of completed chemotherapy courses, simultaneous suffering from other diseases, the duration of surgery if surgery is performed, the amount of exercise per week, height, weight, and BMI.

2. Women's Sexual Performance Index (FSFI) Questionnaire: The mentioned questionnaire has been used in many studies outside of Iran. Considering the high scores and the shortness of the questionnaire, the index of women's sexual performance seems suitable for measuring sexual performance(24). This questionnaire is one of the appropriate tools for the index of women's sexual performance, which examines women's sexual performance in 6 areas with 19 questions. Regarding the scoring method, according to the instructions of the questionnaire designer, the scores of each field are obtained by summing the scores of the questions of each field and multiplying them by the factor number. Since the number of questions in the fields is not equal to each other in the questionnaire, first, to weigh the fields equally, the scores obtained from the questions of each field were added together and then multiplied by the factor number. By adding the scores of the six fields together, the scale's total score was obtained. This way, scoring has been done so that an advanced score shows an excellent sexual function. Constructed on equal weighting of the areas, the maximum score for each area will be six, and the whole scale will be 36. A score of zero means that the person has not had sexual activity during the last four weeks. The cut-off point for the whole scale and the subscales are full scale 28, desire 3.3, psychological stimulation 3.4, humidity 3.4, orgasm 3.4, satisfaction 3.8, and sexual pain 3.8. In other words, scores higher than the cut point indicate good performance. This questionnaire has shown a high degree of internal homogeneity and reliability, and the studies have shown a significant difference between the scores of the patient and control groups in all six domains. In Iran, the scale index of women's sexual performance has been standardized by Mohammadi and his colleagues. According to Mohammadi's study, the reliability of the index for each of the six areas and the full scale for the case groups, control, and all people has been calculated using Cronbach's alpha coefficient (r = 0.85) (25); According to Jalali's study, and using the Cronbach's alpha coefficient retest (r = 0.79) it was significant (26). Also, zeighmi and his colleagues have approved this questionnaire in terms of content validity;(27); Also, according to the results obtained in Mohammadi's research, from the point of view of reliability or validity, it has also shown a significant difference between the scores of the patient group and the control group in all six domains(25); According to Jalali's study and by using Cronbach's alpha coefficient retest (r = 0.79) it was significant (26) and also Zeighmi, and his colleagues confirmed this questionnaire by Cronbach's alpha method (r = 0.94)(27).

3. International Index of Erectile Function in Men Questionnaire (IIEF): The International Index of Male Erectile Function Questionnaire is a scale for measuring men's sexual performance. This questionnaire consists of 15 questions that examine the erectile function of men in 5 subscales. Regarding the scoring of the questionnaire, based on the designer's instructions, the score related to the participants' answers was summed up, and the score related to each subscale was obtained in this way. This questionnaire has no cut-off point, and the researcher standardizes all scores. This questionnaire was created by Rosen and his colleagues (1997) and validated in a group of men with sexual arousal disorder. The aforementioned questionnaire has been used in many studies. It has shown a high degree of internal consistency and reliability. The studies have also shown significant differences between the scores of the patient group and control groups' scores in all five subscales. Considering the high scores and the shortness of the questionnaire, it seems that men's sexual performance index is suitable for measuring sexual performance(28). According to the studies of Rosen and his colleagues, the reliability index for each of the five subscales and the whole scale has an internal consistency with a specific value greater than1.0, and the Cronbach's alpha coefficient was higher than 0.73 or higher than 0.91 in the studied population. The correlation coefficient for the five subscale scores was significant in the retest test. All five subscales had a high degree of sensitivity and specific effects in the treatment group. Significant changes were observed between the scores before and after the treatment. (P Value = 0.0001) (28). Also, the reliability coefficient of this scale was calculated to be 0.96 in Benner's study (29). This questionnaire is approved by many countries and used (30). Pakpour et al., in their study entitled Validation of the translated and culturally adapted Iranian version of the IIEF questionnaire, determined that, according to urologists, there is a significant correlation between the IIEF-I scales and the clinical rating of erectile function. Therefore, this questionnaire has good convergent validity (31); While studying the self-validity of this questionnaire, Jalali conducted this questionnaire on 50 people from the research community and calculated the correlation for it, and the significant Pearson correlation coefficient (p = 0.47) has been calculated(26). In their study, Pakpour et al. determined Cronbach's alpha to be more than 0.70, which is a suitable and acceptable value according to the acceptable value of Cronbach's alpha (31); In the study of Godari et al., the test-retest method was used, for this purpose, the questionnaires were given to 10 patients with type 2 diabetes in two stages, ten days apart, and the correlation between the two tests for the International Performance Scale Erectile dysfunction was calculated as 0.87 (32); While studying the self-reliability of this questionnaire, Jalali has conducted this questionnaire on 50 people from the research community, after two weeks, he has re-administered the IIEF scale on the same people, and its reliability has been confirmed by Cronbach's alpha method(r = 0.75) (26).

The results obtained in each questionnaire are presented in the form of a table in this part, the first table shows distribution of frequency and percentage of individual social characteristics of the samples by gender and having and not having a bag and comparing the classes, the second table shows Distribution of frequency, percentage, the mean and standard deviation of women's sexual performance index and comparing the scores separately for having and not having a bag, the third table shows Univariate and multiple linear regression model of women's sexual performance index to compare two groups with and without colostomy, the fourth table shows distribution of frequency, percentage, the mean and standard deviation of the international index of erectile function and comparing the scores separately for having and not having a bag, the fifth table shows distribution of raw and standardized scores of the International Index of Erectile Function and the sixth table shows Univariate and multiple linear regression model of the international index of erectile function to compare two groups with and without a bag .

P-value	Female		P-value	Male		P-value	Total		Floor	Variable
	No colostomy number (percentage)	with colostomy number (percentage)		No colostomy number (percentage)	with colostomy number (percentage)		No colostomy number (percentage)	with colostomy number (percentage)
	63 (6/49)	64 (4/50)		66 (2/51)	63 (8/48)		129 (4/50)	127 (6/49)
0.361 ^*	22(9/57)	16(1/42)	^** 0.009	12(4/41)	17(6/58)	^* 0.157	34(7/50)	33(3/49)	30 to 40 years	Age
	16(5/61)	10(5/38)		11(0/55)	9(0/45)		27(7/58)	19(3/41)	40 to 50 years
	16(1/38)	26(9/61)		26(1/49)	27(9/50)		42(2/44)	53(8/55)	50 to 60 years
	9(9/42)	12(1/57)		17(0/63)	10(0/37)		26(2/54)	22(8/45)	More than 60 years
^* 0.803	4(0/40)	6(0/60)	^** 0.808	7(3/58)	5(7/41)	^* 0.998	11(0/50)	11(0/50)	Single	marital status
	48(0/50)	48(0/50)		56(9/50)	54(1/49)		104(5/50)	102(5/49)	Married
	11(4/52)	10(6/47)		3(9/42)	4(1/57)		14(0/50)	14(0/50)	Divorced and widowed
^* 0.015	22(8/68)	10(3/31)	^* 0.001	35(4/71)	14(6/28)	^* 0.001 >	57(4/70)	24(6/29)	Chemotherapy	Type of treatment
	23(1/51)	22(9/48)		21(6/39)	32(4/60)		44(9/44)	54(1/55)	Chemotherapy-radiotherapy-surgery
	18(0/36)	32(0/64)		10(0/37)	17(0/63)		28(4/36)	49(6/63)	Chemotherapy-surgery
^* 0.300	57(4/51)	54(6/48)	^* 0.126	64(9/52)	57(1/47)	^* 0.079	121(2/52)	111(8/47)	Five>	Last chemotherapy (week)
	6(5/37)	10(5/62)		2(0/25)	6(0/75)		8(3/33)	16(7/66)	≥ 5–10
	2.69(4.22)	3.04(3.74)		2.68(3.04)	4.01(4.91)		2.69(3.65)	3.52(4.37)	Mean (standard deviation)
^* 0.132	29(3/43)	38(7/56)	^* 0.119	32(3/59)	22(7/40)	^* 0.995	61(4/50)	60(6/49)	Yes	family history
^* 0.132	34(7/56)	26(3/43)	^* 0.119	34(3/45)	41(7/54)	^* 0.995	68(4/50)	67(6/49)	no	family history
^* 0.914	38(0/50)	38(0/50)	^* 0.901	37(7/50)	36(3/49)	^* 0.983	75(3/50)	74(7/49)	Yes	metastasis
^* 0.914	25(0/49)	26(0/51)	^* 0.901	29(8/51)	27(2/48)	^* 0.983	54(5/50)	53(5/49)	no	metastasis
^** 0.001 >	35(6/55)	28(4/44)	^** 0.016	42(8/56)	32(2/43)	^** 0.001 >	77(2/56)	60(8/43)	> 10	Number of chemotherapy courses (number)
	22(4/52)	20(6/47)		19(2/45)	23(8/54)		41(8/48)	43(2/51)	10–20 ≥
	6(3/27)	16(7/72)		5(5/38)	8(5/61)		11(4/31)	24(6/68)	20–30 ≤
	9.13(6.01)	10.97(7.54)		7.61(6.30)	9.70(7.69)		1.48(0.65)	1.71(0.76)	Mean (standard deviation)
^* 0.788	33(8/50)	32(2/49)	^* 0.260	18(9/43)	23(1/56)	^* 0.540	51(1/48)	55(9/51)	Yes	Other diseases
^* 0.788	30(4/48)	32(6/51)	^* 0.260	48(5/54)	40(5/45)	^* 0.540	78(0/52)	72(0/48)	no	Other diseases
^* 0.668	53(5/50)	52(5/49)	^* 0.814	60(8/50)	58(9/42)	^* 0.815	113(7/50)	110(3/49)	1–10 months	Duration of surgery (months)
	10(5/45)	12(5/54)		6(5/54)	5(5/45)		16(5/48)	17(5/51)	11–20 and above
	5.52(5.60)	8.50(4.96)		4.64(5.64)	5.54(5.19)		5.22(5.63)	7.03(5.27)	Mean (standard deviation)
^* 0.151	61(8/48)	64(2/51)	^* 0.087	63(0/50)	63(0/50)	^* 0.025	124(4/49)	127(6/50)	Positive	Sexual activity before the disease
^* 0.151	2(100)	0	^* 0.087	3(100)	0	^* 0.025	5(100)	0	negative	Sexual activity before the disease
^* 0.001 >	10(3/31)	22(8/68)	^* 0.001 >	20(5/64)	11(5/35)	^* 0.001	30(6/47)	33(4/52)	45–65	weight (kg)
	33(1/54)	28(9/45)		31(7/47)	34(3/52)		64(8/50)	62(2/49)	65–85 ≥
	20(8/58)	14(2/41)		15(5/45)	18(5/54)		35(2/52)	32(8/47)	85–105 ≥
	78.63(13.12)	72.21(17.03)		71.37(41.73)	76.84(14.75)		105.0(14.38)	74.51(14.52)	Mean (standard deviation)
Constant	0	0	^* 0.087	3(100)	0	^* 0.084	3(100)	0	70–130	height (cm)
	63(6/49)	64(4/50)		63(0/50)	63(0/50)		126(8/49)	127(2/50)	130–192 ≤
	169.11(7.03)	167.18(8.00)		167.51(22.63)	173.66(8.27)		168.29(16.29)	170.40(8.73)	Mean (standard deviation)
^** 0.654	4(0/50)	4(0/50)	^** 0.239	2(0/50)	2(0/50)	^* 0.804	6(0/50)	6(0/50)	< 18.5	body mass index (kilograms/square meter)
	17(5/41)	24(5/58)		47(3/57)	35(7/42)		64(0/52)	59(0/48)	18.5–25 ≤
	26(2/54)	22(8/45)		9(4/47)	10(6/52)		35(2/52)	32(8/47)	25–30 ≤
	16(3/53)	14(7/46)		8(3/33)	16(7/66)		24 (4/44)	30(6/55)	30 ≤
	27.42(4.54)	26.37(5.07)		24.01(4.18)	25.80(4.56)		25.68(4.67)	26.09(4.81)	Mean (standard deviation)
* Chi-square test
** chi-square test based on Monte-Carlo Simulation

P-value (quantitative)	P-value ( Qualitative)	Female without colostomy number (percentage(	Female with colostomy number (percentage(	class	Performance area
^***001/0<	0/001^*	22(9/34)	6(4/9)	desirable performance (> 3/3)	sexual desire
		41(1/65)	58(6/90)	Poor performance (≤ 3/3)
		63(0/100)	64(0/100)	total
		66/2(34/1)	72/1(92/0)	(mean)standard deviation
^***001/0	0/051^**	8(1/13)	2(1/3)	desirable performance (> 4/3)	mental stimulation
		53(9/86)	62(9/96)	Poor performance (≤ 4/3)
		63(0/100)	64(0/100)	total
		38/2(41/1)	72/1(60/0)	(mean)standard deviation
^***001/0<	0/001^*	25(7/39)	6(4/9)	desirable performance (> 4/3)	humidity
		38(3/60)	58(6/90)	Poor performance (≤ 4/.3)
		63(0/100)	64(0/100)	total
		25/2(85/1)	71/0(37/1)	(mean)standard deviation
^***001/0<	0/001^*	25(7/39)	8(5/12)	desirable performance (> 4/3)	orgasm
		38(3/60)	56(5/87)	Poor performance (≤ 4/3)
		63(0/100)	64(0/100)	total
		27/2(91/1)	76/0(46/1)	(mean)standard deviation
^***001/0<	0/003^*	16(4/25)	4(3/6)	desirable performance (> 8/3)	satisfaction
		47(6/74)	60(8/93)	Poor performance (≤ 8/3)
		63(0/100)	64(0/100)	total
		69/2(48/1)	48/1(17/1)	(mean)standard deviation
^***001/0<	0/003^*	16(4/25)	4(3/6)	desirable performance (> 8/3)	Sexual pain
		47(6/74)	60(8/93)	Poor performance (≤ 8/3)
		63(0/100)	64(0/100)	total
		39/2(94/1)	80/0(48/1)	(mean)standard deviation
^***001/0<	0/496^**	2(2/3)	0	desirable performance (> 28)	Total score
		61(8/96)	62(0/100)	Poor performance (≤ 28)
		63(0/100)	64(0/100)	total
		67/14(10/9)	21/7(40/6)	(mean)standard deviation
* Chi-square test
**Chi-square test based on Monte Carlo simulation
***T-test of two independent groups

Multiple linear regression		Univariate linear regression		class	variable
P	β (95% CI)	P	β (95% CI)
< 001/0	(56/2- ،36/7-)96/4-	< 001/0	(70/4- ، 22/10-)46/7-	With colostomy	group
reference string		reference string		Without colostomy

P-value (Standardized & quantitative)	P-value Qualitative))	male without colostomy number (percentage(	male with colostomy number (percentage(	class	Performance area
^***189/0	^*328/0	20(3/30)	19(2/30)	severe disorder (1–6)	Erectile function
		22(3/33)	27(9/42)	Moderate disorder (7–12)
		14(2/21)	9(3/14)	Mild to moderate disorder (13–18)
		7(6/10)	8(7/12)	Mild disorder (19–24)
		3(5/4)	0	No disturbance (25–30)
		66(0/100)	63(0/100)	total
		67/11(24/6)	25/10(89/5)	(mean)standard deviation
^***292/0	^*178/0	28(4/42)	28(4/44)	severe disorder (0–2)	Orgasm function
		14(2/21)	21(3/33)	Moderate disorder (3–4)
		16(2/24)	7(1/11)	Mild to moderate disorder (5–6)
		8(1/12)	7(1/11)	Mild disorder (7–8)
		0	0	No disturbance (9–10)
		66(0/100)	63(0/100)	total
		05/4(15/2)	67/3(90/1)	(mean)standard deviation
^***292/0	^*178/0	28(4/42)	28(4/44)	severe disorder (= 2)	sexual desire
		14(2/21)	21(3/33)	Moderate disorder (3–4)
		16(2/24)	7(1/11)	Mild to moderate disorder (5–6)
		8(1/12)	7(1/11)	Mild disorder (7–8)
		0	0	No disturbance (9–10)
		66(0/100)	63(0/100)	total
		05/4(15/2)	67/3(90/1)	(mean)standard deviation
^***413/0	^**263/0	32(5/48)	32(8/50)	Severe disorder (0–3)	Satisfaction with sexual contact
		3(5/4)	8(7/12)	Moderate disorder (4–6)
		15(7/22)	10(9/15)	Mild to moderate disorder (7–9)
		14(2/21)	13(6/20)	Mild disorder (10–12)
		2(0/3)	0	No disturbance (13–15)
		66(0/100)	63(0/100)	total
		97/4(11/5)	25/4(75/4)	(mean)standard deviation
^***973/0	^*076/0	30(5/45)	23(5/36)	Severe disorder (= 2)	Comprehensive satisfaction
		12(2/18)	23(5/36)	Moderate disorder (3–4)
		9(6/13)	5(9/7)	Mild to moderate disorder (5–6)
		12(2/18)	6(5/9)	Mild disorder (7–8)
		3(5/4)	6(5/9)	No disturbance (9–10)
		66(0/100)	63(0/100)	total
		32/4(53/2)	33/4(48/2)	(mean)standard deviation
^***318/0	^*207/0	29(9/43)	34(0/54)	Severe disorder (6–20)	Total score
		10(2/15)	11(5/17)	Moderate disorder (21–32)
		11(7/16)	8(7/12)	Mild to moderate disorder (33–45)
		11(7/16)	10(9/15)	Mild disorder (46–58)
		5(6/7)	0	No disturbance (59–75)
		66(0/100)	63(0/100)	total
		05/29(14/17)	17/26(30/15)	(mean)standard deviation
* Chi-square test
**Chi-square test based on Monte Carlo simulation
***T-test of two independent groups

Standardized mean (standard deviation)		95% confidence interval		Mean (standard deviation)		Maximum the score	Minimum for the score	Number of items	Performance area
Without colostomy	With colostomy	Without colostomy	With colostomy	Without colostomy	With colostomy	Maximum the score	Minimum for the score	Number of items	Performance area
89/38(81/20)	18/34(64/19)	20/13–13/10	74/11–77/8	67/11(24/6)	25/10(89/5)	30	0	6	Erectile function
45/40(51/21)	67/36(00/19)	57/4–52/3	15/4–19/3	05/4(15/2)	67/3(90/1)	10	0	2	Orgasm function
57/25(89/26)	83/20(76/23)	57/4–52/3	15/4–19/3	05/4(15/2)	67/3(90/1)	10	2	2	sexual desire
13/33(11/34)	36/28(70/31)	23/6–71/3	45/5–06/3	97/4(11/5)	25/4(75/4)	15	0	2	Satisfaction with sexual contact
98/28(63/31)	17/29(10/31)	94/4–70/3	96/4–71/3	32/4(53/2)	33/4(48/2)	10	2	2	Comprehensive satisfaction
28/35(14/24)	23/31(56/21)	26/33–83/24	03/30–32/22	05/29(14/17)	17/26(30/15)	75	4	15	Total score

Multiple linear regression		Univariate linear regression		class	variant
P	β (95% CI)	P	β (95% CI)
023/0	(33/1- ،32/17-)32/9-	318/0	(94/3 ، 03/12-)04/4-	With colotomy	group
reference string		reference string		Without colostomy

One of the current research findings was that both men and women with colorectal Cancer had a low sexual performance score regardless of the colostomy bag. Previous studies have mentioned that the presence of a stoma can cause a decrease in sexual function(33–36). However, the topic of sex in patients who have an ostomy has been less studied. This is because ostomies are usually examined from a surgical point of view. Moreover, the psychological and psycho-emotional effects it creates are not paid attention to (37).

Previous studies pointed out the need to pay special attention to sexual health in people with colorectal cancer (38), and the present study also confirms this issue.

A study compared women and men with colorectal Cancer in terms of sexual performance and did not measure the difference between people with a pouch and those without a pouch. Therefore one of the most important findings of the current study is the absence of a statistically significant difference between men. With a colostomy and without a colostomy, both groups are at a low level in terms of the sexual performance score, which needs support. However, no significant difference was observed among men.

Another important finding of this study is a statistically significant difference between women with colostomy and those without colostomy. The sexual performance score is lower in women with a colostomy than those without a colostomy. Satisfaction and sexual pain have a statistical difference. In a quantitative comparison, there was a statistical difference in all dimensions of the FSFI, and this shows that women should be supported in all areas.

The passage of time is the most critical factor in successfully adapting to life with an ostomy. Many problems, such as changes in body appearance, anxiety about stool leakage from the ostomy bag, lousy odor, bowel sounds, and loss of libido, decrease over time(39). Also, in this case, some studies on supportive intervention Immediately after the ostomy surgery emphasize (35) the findings of the present study emphasize that the intervention after the surgery should be done immediately, so special care and attention to these cases should be done as soon as possible after the surgery.

Studies on cancer patients show that the severity of the disease and the mental pressure caused by the disease is related to the quality of life of these people(40). According to the WHO definition, sexual health is a fundamental issue for the general health and well-being of individuals, couples, and families and the social and economic development of societies and countries(41). Sexuality is recognized as one of the main aspects of being human and an integral part of the overall quality of life(38). In this background, sexual activity and sexual performance show an imperative role and directly affect the quality of life, unfortunately, immediately after the diagnosis of Cancer, most patients focus on anti-cancer treatment and its challenges, and the sexual dimension is taken as an unseen issue (42). A previous study has determined that older adults who are sexually active enjoy their life more and feel healthy than those who are sexually inactive (43). The field of sexual performance has not only improved one of the essential aspects of these people's lives but also indirectly improved their quality of life.

These findings show the importance of identifying and addressing sexual concerns in colon cancer patients in the early stages of attention to bound the adverse possessions on dear associations and patients' well-being. A previous study has shown that in comparison with men, women are meaningfully less likely to discuss their concerns about their sexual problems(44). Also, the study has determined that women with a colostomy are more likely than women without a colostomy. In terms of sexual performance, which is not the case for men; therefore, the adoption of interventions, significantly to help solve the sexual concerns of women undergoing cancer treatment needs particular attention, although it should be noted that some studies indicate that dysfunction Sex in cancer patients is related to gender. Men experience more sexual problems than women in this case(19, 35, 45), while other studies do not accept this issue depending on gender (46), so it is essential. Despite the present study's findings, patients should be evaluated regardless of gender, age, partner status, and treatment status.

For married women, there is a fear of rejection by the partner and difficulty maintaining the relationship, as both parties adjust. Several qualitative studies show that the refusal or acceptance of a life partner significantly contributes to the acceptance or rejection of a woman's stoma and adaptation to sexual problems and intimate relationships(45, 47). when supporting, providing services, and designing an intervention program to improve the quality of sexual life, they should not consider only the patient, and both couples should be taken care of.

Limitations of the study: In this research, the factors that affect sexual performance were not investigated, so it is suggested that researchers investigate the factors related to sexual performance in future studies. It seems that cultural factors influence the results of this research, so it is suggested that future research with the same title or with a similar title be conducted in another cultural context to reveal this issue. In this research, the items in the demographic information questionnaire were entered into a linear regression to make it clear that the results of the research are only due to the presence of the colostomy bag, and there is no confounding variable, so it is suggested to include more items in the future research than the ones in this research. It has been considered to enter the linear regression as a confounding variable. Because the researcher has extracted the present research from his thesis and because he was a student at the time of conducting the above study, there was a time limit, so it is suggested that researchers who do not have time limits should do the same or similar research with the number of Do more samples so that the obtained results are more generalizable than the current research.

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AMD, MHS designed the study. AMD collected the data. NG, AMD analyzed the data. MHS supervised the study. AMD involved in manuscript writing. MHS, NG involved in critical revisions for important intellectual content. All authors approved the manuscript.

· Acknowledgements

This study was conducted as part of the Master Thesis of the first author at the Tabriz University of Medical Sciences

No competing interests reported.

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