Efficacy and Safety of Transcutaneous Posterior Tibial Nerve Stimulation on Fecal Continence in Patients Undergoing Surgery for Rectal Neoplasia
Randomized Clinical Trial Assessing the Efficacy and Safety of Transcutaneous Posterior Tibial Nerve Stimulation on Fecal Continence in Patients Undergoing Surgery for Rectal Neoplasia
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Meritxell Font
- Numer telefonu: +34 676131774
- E-mail: meritxell.fontprat@gmail.com
Lokalizacje studiów
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Barcelona
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Manresa, Barcelona, Hiszpania, 08243
- Rekrutacyjny
- Althaia Xarxa Assistencial Universitària de Manresa
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Kontakt:
- Anna Arnau, PhD
- Numer telefonu: 3414 +34 93 875 93 00
- E-mail: aarnau@althaia.cat
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Główny śledczy:
- Meritxell Font Prat, MD
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Manresa, Barcelona, Hiszpania, 08243
- Rekrutacyjny
- Xarxa Assistencial Universitària de Manresa, Althaia
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Kontakt:
- Meritxell Font, Medical doctor
- Numer telefonu: +34 676131774
- E-mail: meritxell.fontprat@gmail.com
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Główny śledczy:
- Ignasi Puig, Medical doctor
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Pod-śledczy:
- Meritxell Font, Medical doctor
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Pod-śledczy:
- Sheila Serra, Medical doctor
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Adult patients diagnosed with rectal neoplasia and who have undergone a high anterior rectal resection regardless of the surgical approach (open, laparoscopic, laparoscopic+TaTME or robotic+TaTME).
Exclusion Criteria:
- Patients not operated or within active surveillance strategy programs (watch & wait)
- Patients with ostomy
Patients with contraindications to the use of the neurostimulator:
- Pacemaker / Defibrillator / Other electronic devices
- History of heart problems
- Propensity to excessive bleeding (coagulopathies)
- Damage to the nervous system (epilepsy)
- Current pregnancy
- Infections or skin lesions
- Severe vascular disorders
- Active neoplasms.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Intervention group
Posterior tibial nerve stimulation with Beurer EM-49 digital neuroestimulator at complete doses
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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:
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Pozorny komparator: Control group
Posterior tibial nerve stimulation with Beurer EM-49 digital neuroestimulator at subtherapeutic doses
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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:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Faecal incontinence (FI) - LARS 1st month
Ramy czasowe: 1st month post-surgery
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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).
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1st month post-surgery
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Faecal incontinence (FI) - LARS 6th month
Ramy czasowe: 6th month post-surgery
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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).
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6th month post-surgery
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Faecal incontinence (FI) - LARS 12th month
Ramy czasowe: 12th month post-surgery
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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).
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12th month post-surgery
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Feacal incontinence (FI) - Wexner 1st month
Ramy czasowe: 1st month post-surgery
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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.
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1st month post-surgery
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Faecal incontinence (FI) - Wexner 6th month
Ramy czasowe: 6th month post-surgery
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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.
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6th month post-surgery
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Faecal incontinece (FI) - Wexner 12th month
Ramy czasowe: 12th month post-surgery
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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.
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12th month post-surgery
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Sexual impairment 1st month
Ramy czasowe: 1st month post-surgery
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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) |
1st month post-surgery
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Sexual impairment - 6th month
Ramy czasowe: 6th month post-surgery
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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)
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6th month post-surgery
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Sexual impairment - 12th month
Ramy czasowe: 12th month post-surgery
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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)
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12th month post-surgery
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Quality of life (QoL) - FIQLS 1st month
Ramy czasowe: 1st month post-surgery
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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. |
1st month post-surgery
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Quality of life (QoL) - FIQLS 6th month
Ramy czasowe: 6th month post-surgery
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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 |
6th month post-surgery
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Quality of life (QoL) - FIQLS 12th month
Ramy czasowe: 12th month post-surgery
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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 |
12th month post-surgery
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Quality of life (QoL) - QLQ-CR 38 1st month
Ramy czasowe: 1st month
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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 |
1st month
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Quality of life (QoL) - QLQ-CR38 6th month
Ramy czasowe: 6th month post-surgery
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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 |
6th month post-surgery
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Quality of life (QoL) - QLQ-CR38 12th month
Ramy czasowe: 12th month post-surgery
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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 |
12th month post-surgery
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Patient global impression of improvement (PGI-I)
Ramy czasowe: 1 year
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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. |
1 year
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Patient's characteristics
Ramy czasowe: At the enrollment
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Age at diagnosis (years), sex (man/woman), height (m), weight (kg), BMI (kg/m2), prior anorectal disease (yes and not, if yes should specify)
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At the enrollment
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Concomitant medication for stool
Ramy czasowe: At the enrollment
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methylcellulose, loperamide, ... (yes or no, if yes should specify)
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At the enrollment
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Tumor characteristics
Ramy czasowe: At the enrollment
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Date of diagnosis (exact day), clinical TNM stage (TNM), tumour height from the anal verge by colonoscopy (cm) and proctoscopy (cm) magnetic resonance imaging findings (TNM, cm to anal verge), neadjuvant treatment (yes or no, which type), CEA values (ng/mL), neutrophil and lymphocyte values pre and post-chemotherapy (absolut value x10e9)
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At the enrollment
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Surgical details
Ramy czasowe: At the enrollment
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Date of surgery, surgical approach (laparoscopic (LAP), robotic (ROB), LAP + transanal (TaTME), ROB + TaTME), transanal extraction of the specimen (yes or no), intraoperative complications (specify), type of anastomosis (mechanic, manual), height of anastomosis (cm), protective ileostomy (yes or no)
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At the enrollment
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Follow-up
Ramy czasowe: From the surgical day (day 1) to the end of the study (day 360)
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Days of hospital stay (days), days until intake (days), postoperative complications (yes or no, if yes specify and complete Clavien-Dindo clasification), treatment of postoperative complication (need of new surgery, yes or no, if yes specify surgical procedure), readmission (yes or no, specify why)
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From the surgical day (day 1) to the end of the study (day 360)
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Esphinteric funcionality
Ramy czasowe: At 1st month and 12th month from day 1 (surgery day)
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Rectal examination with basal tone and transperineal ultrasound (normal, insufficient expulsive maneuver, sphincter defect, anism, rectal hypersensitivity, rectal hyposensitivity, not performed), Oxford classification of esphinteric muscular strenght (0 to 5, being 5 good function).
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At 1st month and 12th month from day 1 (surgery day)
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Compliance diary
Ramy czasowe: 1 year
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Registration of the sessions done and observations
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1 year
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Współpracownicy i badacze
Publikacje i pomocne linki
Przydatne linki
- Sociedad Española de Oncología Médica (SEOM). Las cifras del càncer en España. 2024.
- El cáncer en España, datos y estadísticas. Epdata.
- Ma B, Gao P, Song Y, Zhang C, Zhang C, Wang L, et al. Transanal total mesorectal excision (taTME) for rectal cancer: A systematic review and meta-analysis of oncological and perioperative outcomes compared with laparoscopic total mesorectal excision.
- Muratore A, Mellano A, Marsanic P, De Simone M. Transanal total mesorectal excision (taTME) for cancer located in the lower rectum: Short- and mid-term results. European Journal of Surgical Oncology. 2015; 41(4): 478-83.
- Color II Study Group, Buunen M, Bonjer HJ, Hop WCJ, Haglind E, Kurlberg G, et al. COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer. Danish Medical Bulletin. 2009; 56(2): 89-91.
- Van der Pas MH, Haglind E, Cuesta MA, Fürst A, Lacy AM, Hop WC, et al. Laparoscopic versus open surgery for rectal cancer (COLOR II): short-term outcomes of a randomised, phase 3 trial. Lancet Oncology. 2013; 14(3): 210-8.
- Sanchon L., Bardají M., Labró M., Curto J., Soto C., Puig A., et al. Oncological monitoring after transanal total mesorectal excision (TaTME) for rectal neoplàsia. Techniques in Coloproctology. 2023: 27(9):739-746.
- Grass J. K., Chen C-C., Melling N., Lingala B., Kemper M., Scognamiglio P., et al. Robotic rectal resection preserves anorectal function: systematic review and meta-analysis. Int J Med Robot. 2021; 17(6):e2329.
- Emmertsen KJ, Laurberg S. Low anterior resection syndrome score: development and validation of a symptom-based scoring system for bowel dysfunction after low anterior resection for rectal cancer. Annals of Surgery. 2012; 255(5): 922-8.
- Sörensson M, Asplund D, Matthiessen P, Rosenberg J, Hallgren T, Rosander C, et al. Self-reported sexual dysfunction in patients with rectal cancer. Color Disease. 2020; 22(5): 500-12.
- Carrillo A, Enríquez-Navascués JM, Rodríguez A, Placer C, Múgica JA, Saralegui Y, et al. Incidencia y caracterización del síndrome de resección anterior de recto mediante la utilización de la escala LARS (low anterior resection score). Cirugía Españo
- Kauff DW, Roth YDS, Bettzieche RS, Kneist W. Fecal incontinence after total mesorectal excision for rectal cancer-impact of potential risk factors and pelvic intraoperative neuromonitoring. World Journal of Surgical Oncology. 2020; 18(1).
- Zhang, L., Hu C., Zhao J., Wu C., Zhang Z., Li R., et al. The effect of robotic surgery on low anterior resection syndrome in patients with lower rectal cancer: a propensity score-matched analysis. Surgical Endoscopy 2024; 38(4): 1912-1921.
- Vidal C., Romero G., Jané C., Vidal L., Arnau A., Rosal A., et al. Intervención no farmacològica para mejorar la calidad de vida de los pacientes intervenidos de resección anterior de recto. Revista Sociedad Española de Enfermería en Estomaterapia. 2
- Rosen H., Sebesta C.G., Sebesta C. Cancers (Basel). 2023; 15(3): 778
- Nguyen TH, Chokshi R V. Low Anterior Resection Syndrome. Current Gastroenterology Reports. Springer; 2020; 22(10): 48.
- Ciriza de los Ríos C, Ruiz de León A, García Durán F, Tomás Moros E, Carneros Martín JA, Muñoz Yagüe T, et al. Calidad de vida en pacientes con incontinencia fecal y su relación con la gravedad de la misma.Gastroenterología Hepatología. 2010; 33(9):621-8
- Efisioterapia. T.E.N.S. Estimulación nerviosa transcutánea. eFisioterapia.net. 2007.
- Medicina del Dolor. Hospital VITHAS Valencia.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby układu moczowo-płciowego
- Choroby narządów płciowych
- Powikłania pooperacyjne
- Procesy patologiczne
- Nowotwory według lokalizacji
- Nowotwory
- Choroby narządów płciowych, mężczyzna
- Choroby układu moczowo-płciowego u mężczyzn
- Choroby jelit
- Nowotwory przewodu pokarmowego
- Nowotwory Układu Pokarmowego
- Choroby Układu Pokarmowego
- Choroby przewodu pokarmowego
- Nowotwory jelita grubego
- Nowotwory jelit
- Choroby odbytu
- Choroby okrężnicy
- Zaburzenia seksualne, fizjologiczne
- Stany patologiczne, oznaki i objawy
- Zespół niskiej resekcji przedniej
- Zaburzenia wytrysku
- Nowotwory odbytnicy
- Nietrzymanie stolca
- Techniki śledcze
- Projekt badań epidemiologicznych
- Metody epidemiologiczne
- Projekt badań
- Metody
- Grupy kontrolne
Inne numery identyfikacyjne badania
- CEIm 25/080
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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