Rectal neoplasia is one of the most prevalent cancers in Spain, and the treatment of choice is total mesorectal excision (TME), as it has demonstrated significant oncological improvements. However, mesorectal excision is not without complications, and patients often experience altered bowel function in the form of low anterior resection syndrome (LARS), as well as erectile dysfunction. However, few studies evaluate faecal incontinence, as most focus on oncological outcomes. The aim of our study is to evaluate the efficacy and safety of posterior tibial nerve stimulation on fecal incontinence, sexual dysfunction, and quality of life in patients who underwent to rectal surgery for rectal neoplasia. It will be conducted a randomized clinical trial (1:1) with two arms: half of the patients will receive posterior tibial nerve stimulation, while the other half will undergo stimulation with subtherapeutic doses. Faecal incontinence will be assessed using the LARS and Wexner questionnaires, and quality of life and sexual function will be assessed using the Fecal Incontinence Quality of Life Scale (FIQLS) and the Colorectal Cancer Quality of Life Questionnaire (QLQ-CR38), at one month, six months and one year after surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
84
In the intervention group, Beurer EM-49 digital neurostimulator will be used, with CE marking, and a dose of 20 Hertz (Hz) - 200 microseconds (μs) will be applied. As the control group and the intervention group, the pelvic floor rehabilitator will program the neurostimulator for each case and then they will be trained on how to perform the neurostimulation. The first session will be carried out with the rehabilitator to learn how it works and resolve doubts about its use, and later the sessions will be carried out at home. In both groups, a program for carrying out sessions will be indicated according to the following scheme: * From the 1st month to the 3rd month post-surgery: stimulation 3 times a week * From the 4th month to the 6th month post-surgery: stimulation 2 times a week * From the 7th to the 12th month post-surgery: 1 time a week
In the intervention group, Beurer EM-49 digital neurostimulator will be used, with CE marking; and a dose of 80 Hertz (Hz) - 150 microseconds (μs) will be applied. As the control group and the intervention group, the pelvic floor rehabilitator will program the neurostimulator for each case and then they will be trained on how to perform the neurostimulation. In order to apply the therapy, the patient must sit down for the placement of the electrodes. It will be performed on 2 feet at the same time. The first session will be carried out with the rehabilitator to learn how it works and resolve doubts about its use, and later the sessions will be carried out at home. In both groups, a program for carrying out sessions will be indicated according to the following scheme: * From the 1st month to the 3rd month post-surgery: stimulation 3 times a week * From the 4th month to the 6th month post-surgery: stimulation 2 times a week * From the 7th to the 12th month post-surgery: 1 time a week
Althaia Xarxa Assistencial Universitària de Manresa
Manresa, Barcelona, Spain
RECRUITINGXarxa Assistencial Universitària de Manresa, Althaia
Manresa, Barcelona, Spain
RECRUITINGFaecal incontinence (FI) - LARS 1st month
Assessed by LARS questionnaire Low anterior resection syndrome (LARS): LARS scale consists of 5 questions: gas incontinence (0,4,7 points), liquid incontinence (0,3,3 points), stool frequency (4,2,0,5 points), defecation fractionation (0,9,11 points) and defecatory urgency (0, 11,16 points). The score range is between 0 and 42 points. Patients are categorized into three groups: no LARS (0 to 20 points), mild LARS (21 to 29 points) and severe LARS (30 to 42 points).
Time frame: 1st month post-surgery
Faecal incontinence (FI) - LARS 6th month
Assessed by LARS questionnaire Low anterior resection syndrome (LARS): LARS scale consists of 5 questions: gas incontinence (0,4,7 points), liquid incontinence (0,3,3 points), stool frequency (4,2,0,5 points), defecation fractionation (0,9,11 points) and defecatory urgency (0, 11,16 points). The score range is between 0 and 42 points. Patients are categorized into three groups: no LARS (0 to 20 points), mild LARS (21 to 29 points) and severe LARS (30 to 42 points).
Time frame: 6th month post-surgery
Faecal incontinence (FI) - LARS 12th month
Assessed by LARS questionnaire Low anterior resection syndrome (LARS): LARS scale consists of 5 questions: gas incontinence (0,4,7 points), liquid incontinence (0,3,3 points), stool frequency (4,2,0,5 points), defecation fractionation (0,9,11 points) and defecatory urgency (0, 11,16 points). The score range is between 0 and 42 points. Patients are categorized into three groups: no LARS (0 to 20 points), mild LARS (21 to 29 points) and severe LARS (30 to 42 points).
Time frame: 12th month post-surgery
Feacal incontinence (FI) - Wexner 1st month
Assessed by Wexner questionnaire. Wexner scale consists of 5 questions (range 0-4): incontinence of solid stools, incontinence of liquid stools, incontinence of gases, use of pads or diapers and alteration of social life. Depending on the frequency, a score of 0 to 4 is assigned. The score can range from 0 to 20 points, considering no incontinence as 0 to 2 points, mild incontinence as a result of 3 to 6 points, moderate incontinence as 7 to 11 points and severe incontinence as a result greater than or equal to 12 points.
Time frame: 1st month post-surgery
Faecal incontinence (FI) - Wexner 6th month
Assessed by Wexner questionnaire. Wexner scale consists of 5 questions (range 0-4): incontinence of solid stools, incontinence of liquid stools, incontinence of gases, use of pads or diapers and alteration of social life. Depending on the frequency, a score of 0 to 4 is assigned. The score can range from 0 to 20 points, considering no incontinence as 0 to 2 points, mild incontinence as a result of 3 to 6 points, moderate incontinence as 7 to 11 points and severe incontinence as a result greater than or equal to 12 points.
Time frame: 6th month post-surgery
Faecal incontinece (FI) - Wexner 12th month
Assessed by Wexner questionnaire. Wexner scale consists of 5 questions (range 0-4): incontinence of solid stools, incontinence of liquid stools, incontinence of gases, use of pads or diapers and alteration of social life. Depending on the frequency, a score of 0 to 4 is assigned. The score can range from 0 to 20 points, considering no incontinence as 0 to 2 points, mild incontinence as a result of 3 to 6 points, moderate incontinence as 7 to 11 points and severe incontinence as a result greater than or equal to 12 points.
Time frame: 12th month post-surgery
Sexual impairment 1st month
Assessed by QLQ-CR38 questionnaire (question 17-18 for both sexes, 20-21 for men and 22-23 for women). Each question can be answered from 1 to 4 points. And then is it calculated in the sexual impairment analysis (symptoms area)
Time frame: 1st month post-surgery
Sexual impairment - 6th month
Assessed by QLQ-CR38 questionnaire (question 17-18 for both sexes, 20-21 for men and 22-23 for women). Each question can be answered from 1 to 4 points. And then is it calculated in the sexual impairment analysis (symptoms area)
Time frame: 6th month post-surgery
Sexual impairment - 12th month
Assessed by QLQ-CR38 questionnaire (question 17-18 for both sexes, 20-21 for men and 22-23 for women). Each question can be answered from 1 to 4 points. And then is it calculated in the sexual impairment analysis (symptoms area)
Time frame: 12th month post-surgery
Quality of life (QoL) - FIQLS 1st month
Assessed by: -Fecal Incontinence Quality of Life Scale(FIQLS):composed of 29 items that evaluate 4 health dimensions:lifestyle(10 items),behavior(9 items),depression/self-esteem(7 items) and shame(3 items).Each item has a range from 1 to 5,with 1 being the minimum value for the quality of life state.
Time frame: 1st month post-surgery
Quality of life (QoL) - FIQLS 6th month
Assessed by: -Fecal Incontinence Quality of Life Scale(FIQLS):composed of 29 items that evaluate 4 health dimensions:lifestyle(10 items),behavior(9 items),depression/self-esteem(7 items) and shame(3 items).Each item has a range from 1 to 5,with 1 being the minimum value for the quality of life state
Time frame: 6th month post-surgery
Quality of life (QoL) - FIQLS 12th month
Assessed by: -Fecal Incontinence Quality of Life Scale(FIQLS):composed of 29 items that evaluate 4 health dimensions:lifestyle(10 items),behavior(9 items),depression/self-esteem(7 items) and shame(3 items).Each item has a range from 1 to 5,with 1 being the minimum value for the quality of life state
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Time frame: 12th month post-surgery
Quality of life (QoL) - QLQ-CR 38 1st month
Assessed by: -Colorectal Cancer Quality of Life Questionnaire(QLQ-CR38):organized into 2 areas: 1.Functioning area,which includes the body image and sexual functioning scales and the items on enjoying sex and worrying about the future.2.Symptom area with scales for problems with urination,gastrointestinal symptoms,chemotherapy side effects,problems with defecation,problems with the stoma,sexual problems in men and women,and the weight loss item. All scores ranged 1 to 4, and then are lineal transformation is done (0 to 100). In the functioning area,a higher score indicates a better quality of life,while in the symptom area, a higher score indicates a worse quality
Time frame: 1st month
Quality of life (QoL) - QLQ-CR38 6th month
Assessed by: -Colorectal Cancer Quality of Life Questionnaire(QLQ-CR38):organized into 2 areas: 1.Functioning area,which includes the body image and sexual functioning scales and the items on enjoying sex and worrying about the future.2.Symptom area with scales for problems with urination,gastrointestinal symptoms,chemotherapy side effects,problems with defecation,problems with the stoma,sexual problems in men and women,and the weight loss item. All scores ranged 1 to 4, and then are lineal transformation is done (0 to 100). In the functioning area,a higher score indicates a better quality of life,while in the symptom area, a higher score indicates a worse quality
Time frame: 6th month post-surgery
Quality of life (QoL) - QLQ-CR38 12th month
Assessed by: -Colorectal Cancer Quality of Life Questionnaire(QLQ-CR38):organized into 2 areas: 1.Functioning area,which includes the body image and sexual functioning scales and the items on enjoying sex and worrying about the future.2.Symptom area with scales for problems with urination,gastrointestinal symptoms,chemotherapy side effects,problems with defecation,problems with the stoma,sexual problems in men and women,and the weight loss item. All scores ranged 1 to 4, and then are lineal transformation is done (0 to 100). In the functioning area,a higher score indicates a better quality of life,while in the symptom area, a higher score indicates a worse quality
Time frame: 12th month post-surgery
Patient global impression of improvement (PGI-I)
Assessed by PGI-I questionnaire. The Patient Global Improvement Visual Analogue Scale (PGI-I) will be used to allow patients to comparatively assess their degree of global improvement after undergoing posterior tibial nerve stimulation therapy. The scale in question has only one question that asks the patient to classify the degree of symptom relief obtained with the treatment according to the 7-point Likert scale. The higher the score, the better the perception of quality of life.
Time frame: 1 year