Digestive System Diseases

All Conditions

Neoplasms

Symptoms and General Pathology

Fecal Incontinence

Rectal Neoplasms

Anastomotic Leak

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Postoperative Complications

Patients who undergo modified PPS surgery in order to preserve anal sphincter function under the premise of radical resection of ultralow rectal cancer.

Patients who undergo conventional sphincter-preserving surgeries.

Cheng-Le Zhuang, MD, PhD

Zhong-Chen Liu, MD, PhD

RATIONALE: Colorectal cancer is one of the most common cancers. However, approaches to minimize surgical trauma, preserve anal function, avoid abdominal stoma, and improve quality of life for patients with ultralow rectal cancers were limited. Thus, new technologies are urgently needed to improve the anal preservation rate, reduce the incidence of anastomotic leakage and improve postoperative anal function in patients with ultralow rectal cancer.

PURPOSE: This one-arm multicenter prospective cohort study aims to collect the data of patients with ultralow rectal cancer who undergo sphincter-preserving surgeries, including modified PPS and conventional surgeries, then compare the effects of different operations on clinical outcomes and to see the efficacy and safety of modified PPS surgery when compared with conventional procedures in the treatment of ultralow rectal cancer.

Effects of Modified Precision Functional Sphincter-Preserving Surgery (PPS) on Ultralow Rectal Cancer

Effects of Modified Precision Functional Sphincter-Preserving Surgery (PPS) on Ultralow Rectal Cancer: A Multicenter Prospective Cohort Study

The percentage of patients who get temporary defunctioning stoma to limit the consequences of anastomotic leakage.

The percentage of patients who develop anastomotic leakage

Ranging from 0 (perfect continence) to 20 (complete incontinence)

Ranging from 0 (perfect continence) to 24 (complete incontinence)

The percentage of patients who preserve the anatomical structure of the anus

The number of grade II and higher postoperative complications according to the Clavien-Dindo classification

The time between the operation date and the discharge date.

Percentage of readmitted patients within 30 days after operation

Disease-free survival is defined as the time from surgery to recurrence of tumor or death

Overall survival is defined as the time from surgery until death from any cause.

Shanghai 10th People's Hospital

Investigator assistant

Behaviors and Mental Disorders

Syndrome

Low Anterior Resection Syndrome

Colonic Diseases

Quality of Life

BACKGROUND and RATIONALE Colorectal cancer, with 49,000 new diagnoses expected in 2019 (27,000 in men and 22,000 in women) represents, in Italy, the third neoplasm in men (14%) and the second in women (12%). Increasing attention has been recently paid to the outcomes of surgical treatment, in terms of patient's anorectal function and quality of life (QoL). Currently, the majority of patients affected by rectal carcinoma undergo a sphincter-sparing surgery, that is, a low anterior rectal resection (LAR).

It is known that about 50% - 90% of patients undergoing LAR will develop at least some degree of bowel dysfunction: for this reason, the definition of "anterior low rectal resection syndrome" (LARS) has been coined to describe this complex functional condition; the LARS usually includes incontinence to gas and/or liquid or solid stools, constipation, urgency, fragmentation and frequent bowel movements; a worsening of QoL has been also observed.

Due to the importance and high prevalence of this condition, but in the absence of a reliable tool for assessing its severity, the so-called "LARS score" has been introduced. The score has already been validated in several languages, even if this important tool has not been validated in Italian language.

AIMS of the STUDY The primary aim of this study will be the validation in Italian language of the LARS score in a population of Italian patients with a previous history of rectal cancer and treated by anterior rectal resection surgery. Moreover, the convergent and discriminatory validity, and the reliability of the score will be also assessed.

STUDY DESIGN The study will be a prospective observational study on patients affected by rectal cancer and treated by anterior rectal resection surgery with total or partial excision of the mesorectum (TME, total mesorectal excision, or PME, partial mesorectal excision) in the period January 2000 - April 2018. Any Unit of the Fondazione Policlinico Universitario "Agostino Gemelli" - IRCCS of Rome that deals with rectal cancer surgery could join the study.

METHODS The validated English version of the LARS questionnaire will be translated into Italian. The translation will be performed by two independent professional translators.

Based on previous validation studies conducted in other Countries, it has been calculated that the sample size will be 200 patients.

Patients will be assessed by administration of the LARS score questionnaire, of a single question on QoL, and of the EORTC-QLQ-C30 questionnaire.

Each Unit could choose to assess the patients in the preferred way (clinical follow-up visit, e-mail, ordinary mail); however, the method of administration of the questionnaire must be specified in the final communication of data to the coordinating Group. Each Unit joining the Study will be provided with an Excel data collection sheet which must then be completed.

A descriptive analysis of the data will be conducted, and the convergent validity, that is the concordance between the LARS score and the QoL, will be investigated. In addition, discriminatory validity, i.e. the ability of the LARS score to distinguish between subgroups of patients, which usually differ in the LARS score, will be assessed. Finally, the test-retest reliability of the LARS score will be examined, so all patients will receive a second LARS questionnaire 1-2 weeks after completing the first and the results of the two tests will be compared.

1. BACKGROUND and RATIONALE Colorectal cancer, with 49,000 new diagnoses expected in 2019 (27,000 in men and 22,000 in women) represents, in Italy, the third neoplasm in men (14%) and the second in women (12%). Among colorectal tumors, the rectum represents the site most frequently involved (about 35%).

   Thanks to an earlier diagnosis and to the greater effectiveness of an implemented multidisciplinary treatment, the locoregional control and the patients' overall survival significantly improved over the last decades.

   Increasing attention has been recently paid to the outcomes of surgical treatment, in terms of patient's anorectal function and quality of life (QoL). Currently, the majority of patients affected by rectal carcinoma undergo a sphincter-sparing surgery, that is, a low anterior rectal resection (LAR), therefore avoiding a permanent colostomy.

   It is known that about 50% - 90% of patients undergoing LAR will have at least some degree of bowel dysfunction: for this reason, the definition of "anterior low rectal resection syndrome" (LARS) has been coined to describe this complex functional condition. The main symptoms included in this syndrome are: incontinence to gas and/or liquid or solid stools, constipation, urgency, fragmentation and frequent bowel movements. In addition, a worsening of QoL has been observed in patients with severe LARS symptoms.

   Due to the importance and high prevalence of this condition, in order to identify a reliable tool for assessing its severity, the so-called "LARS score" has been introduced. The score has already been validated in several languages, including English, Chinese, Lithuanian, Swedish, Spanish, German, Danish (as consolidated international validation), and finally Dutch.

   However, this important tool has not been validated in Italian language.
2. AIMS The primary aim of this study will be the validation in Italian language of the LARS score in a population of Italian patients with a previous history of rectal cancer, and treated by anterior rectal resection surgery. Moreover, the study will give the possibility to investigate the convergent and discriminatory validity, and to re-test the reliability of the score.
3. STUDY DESIGN The study will be a prospective observational study on patients affected by rectal cancer, and treated by anterior rectal resection surgery with total or partial excision of the mesorectum (TME, total mesorectal excision, or PME, partial mesorectal excision) in the period January 2000 - April 2018. Any Surgical Unit of the Fondazione Policlinico Universitario "Agostino Gemelli" - IRCCS of Rome that deals with rectal cancer surgery could join the study. Each Unit will identify a Study Manager, and possibly a collaborator.
4. METHODS

   The study will provide different phases:
   * TRANSLATION OF THE QUESTIONNAIRE The validated English version of the LARS questionnaire will be translated into Italian. The translation will be performed by two independent professional translators. Translators will discuss any discrepancies between their translations until an agreed version is reached. A third native English translator will translate the Italian version into English. Subsequently, the two English versions (the initial one and the new one) will be compared and the final version in Italian will be elaborated.
   * CONVERGENT VALIDITY To study the "convergent validity", the LARS score will be correlated with the single QoL question and with the EORTC-QLQ-C30 questionnaire, in order to test how the LARS score correlates with the QoL.
   * DIVERGENT VALIDITY To study discriminative validity, we will evaluate the ability of the LARS score to identify different patient subgroups, which generally differ in the LARS score. Similar to previous validation studies, the clinically relevant subgroups will be based on: preoperative radiotherapy, type of surgery (TME / PME), age (cut-off at 69 years).
   * TEST- RETEST RELIABILITY Test-retest reliability is one of the key measures of all health measures. To examine the test-retest reliability of the LARS score, all patients will receive a second LARS questionnaire 1-2 weeks after completing the first one, and will be invited to reply to the questionnaire again.

   Each Unit could choose to assess the patients in the preferred way (clinical follow-up visit, e-mail, ordinary mail); however, the method of administration of the questionnaire must be specified in the final communication of data to the coordinating Group.

   Each Unit will be responsible for the truthfulness of the data collected and provided.
5. DATA COLLECTION

   Each Unit joining the Study will be provided with an Excel data collection sheet which must then be completed. The collection of data and their transmission to the Study Coordinator Group must occur within 3 months from the beginning of the Study. For each patient we ask to provide:
   * 2 LARS questionnaires, administered 1-2 weeks apart;
   * 1 EORTC-QLQ-C30 questionnaire;
   * 1 single QoL question.
6. STATISTICAL ANALYSIS and DATA EVALUATION The quality control of the collected data and the statistical analysis of the results will be conducted by a specialist in Medical Statistics, who will be guaranteed co-authorship in the scientific publications derived from the study. No financial compensation will be provided for this activity.

   Concerning the "convergent validity", the correspondence between the QoL categories (no impact, minor or major impact of intestinal function on QoL) and the three LARS scoring categories will be assessed. The correspondence between these two measures will be considered perfect when: patients have not reported LARS and any impact on QoL; patients have reported minor LARS and a minor impact on QoL; in case of major LARS and major impact on QoL. Correspondence will be defined as moderate in case of a difference in one category, for example no LARS but a minor impact on QoL. In case of difference in two categories, the two measures will be considered not corresponding at all.

   LARS score data will be presented as median (with interquartile range) and the differences will be tested by the Kruskal-Wallis test. The same test will be used to test the null hypothesis in the study of the association between the LARS score and the five functional scales and the global QoL scale of the EORTC-QLQ-C30 questionnaire. Wilcoxon's rank test will be applied to investigate the "discriminatory validity".

   The correspondence between the two tests to measure the reliability of the LARS score will be presented as proportions with 95% confidence intervals (95% CI). A Bland-Altman diagram will be calculated with 95% agreement limits and intraclass correlation (ICC). An ICC lower than 0.50 will indicate poor reliability, an ICC between 0.50 and 0.75 will reflect moderate reliability, between 0.75-0.90 good reliability and an ICC greater than 0.90 will indicate excellent reliability.
7. PUBLICATION POLICY and AUTHORSHIP The results of the study will be the subject of a group publication. The co-authorship of the manager and a collaborator will be guaranteed to each Unit participating in the study. The first, second and last Author of the publication will be respectively the principal investigator and the two collaborators (junior and senior) of the promoter / coordinator Center.

Italian Validation of the LARS Score

Italian Validation of the Low Anterior Resection Syndrome Score

The LARS score, originally developed in Denmark, aims to assess the intestinal dysfunction in a population of rectal cancer patients. The sum of the scores of the five subscales allows to calculate a total score ranging from 0 to 42 points. So, the total score is classified into three groups: 0-20 points: no LARS; 21-29 points: minor LARS; 30-42 points: major LARS.

The EORTC-QLQ-C30 questionnaire is a validated and specific tool to evaluate the QoL of cancer patients. It consists of 30 questions that provide a global QoL scale, five functional scales (i.e. physical, role-playing, emotional, cognitive, social), three symptom scales (fatigue, nausea and vomiting, pain) and six individual factors (dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties). The scores of each scale are calculated in a score ranging from 0 to 100. For the purpose of this study, only the functional scales and the global QoL scale will be used. A high score on a functional scale represents a good level of function.

A single question on QoL will be added to the LARS score for the purpose of investigating convergent validity. The question is: "Overall, how does bowel function affect your quality of life?"; it will be possible to give only one of the following answers: "not at all", "a little", "enough", "a lot". This question had previously been used for the development and validation of the LARS score in other countries. The score ranges from 0 to 4.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Associate Professor

Garazi Elorza, Medical Doctor

Garazi Elorza, MD

Patients with sphincter saving procedures of rectal cancer usually experience intestinal dysfunction, including difficulty emptying the bowel and faecal incontinence, leading to a detriment in the quality of life. A prospective study is proposed to measure de feasibility and the impact of a continuous care programme for the prevention or reduction of intestinal dysfunction disorders. The intervention lies on prehabilitation and rehabilitation with physiotherapy, biofeedback and neuromodulation, is assisted by a telematic information system (APP for the monitoring of education on physiotherapy and surveillance).

-Study design: A single-arm, non-randomized prospective study that will initially evaluate the compliance and feasibility of a prehabilitation and / or functional rehabilitation program in patients with anterior rectal resection with mesorectal excision for rectal cancer. In addition, clinical outcome variables will be obtained to evaluate the possibility of a subsequent efficacy study.

-Patient selection: Participation in this study will be proposed to all consecutive patients with rectal cancer who are expected to perform a low anterior resection of the rectum with mesorectal excision and colorectal anastomosis with or without protective ileostomy, older than 18 years, who give their informed consent, and who can carry out a pelvic floor physiotherapy program and be susceptible to tibial neurostimulation.

Exclusion criteria will be a POLARS score less than 20 (LARS-minor or non-LARS), the existence of residual or distant locoregional disease, the presence of inflammatory bowel disease (IBD), a previous known diagnosis of irritable bowel syndrome (IBS) , patients with intestinal resections other than the rectum, existence of anastomotic complications, or inability to perform pelvic muscle physiotherapy, presence of trophic disorders in the ankles (post-febile syndrome), known diabetic neuropathy, carriers of pacemakers or implantable defibrillators, and with previous SNS or PTNS.

-Interventions:

The package of interventions consists on:

1. Educational session: colorectal nursing consultation, in which the inclusion / exclusion criteria are checked, the preoperative data relative to the outcome measures scales (POLARS, Vaizey and QLQ-C30) and the pre and postoperative clinical variables are filled in of interest to the study.

   After explaining the components, phases and duration of the prehabilitation or rehabilitation program, the informed consent of the patients is obtained.

   In this first visit, the pelvic floor muscle rehabilitation exercises to be performed are shown and supervised, recording the baseline data of the modified Oxford scale and the PERF scheme (Power, Endurance, Repetition, Fast).
2. Pelvic Floor Physical Therapy (FTSP) and Biofeedback: Patients will complete three sets of muscle exercises per day: slow pelvic floor contractions, maximum sustained contractions, and rapid pelvic floor contractions; performing 10 repetitions of each modality per series, with an approximate duration of 2-3 minutes each. These exercises can be performed in any position, moment or circumstance at the convenience of the patients.

   At each visit to the nursing consultation, the exercises will be supervised and on specific dates (see program diagram) the contraction force will be quantified using the modified Oxford scale, the PERF scheme and an anal manometry.

   For anal manometry, the Anopress device (THD SpA, Correggio (RE), Italy) will be used, a portable and wireless manometer that uses high resolution air to fill the probes that register pressures generated in the anal canal. A standard protocol was followed for all patients. Resting pressure data are recorded, with voluntary contractions, involuntary contractions (eg, with coughing) and resistance pressures (the duration of up to 50% of the maximum effort pressure is defined in a maximum of ten seconds). A second catheter with a distensible balloon is used to measure rectal sensitivity to distension and the inhibitory anorectal reflex. There will be 2 biofeedback sessions.

   As controls of adherence to the program, patients will keep either a diary with the exercises performed or the records of the pelvic floor exercise program app.
3. Percutaneous neurostimulation of the posterior tibial nerve: For the PTNS, an Urgent PC® device (Uroplasty, NL) is used; the procedure will be performed in outpatient consultations by colorectal nurses, following the standard technique recommended by the manufacturer. Stimulation is carried out using a 34 G needle electrode inserted at a cranial point 3-4 cm and 2 cm posterior to the medial malleolus, and another adhesive electrode near the arch of the foot of the same leg. The electrostimulation parameters are as follows: a pulse width of 200 ms, a frequency of 20 Hz, and an increased current until flexion of the fingers was first noticed (0-18 mA). The program includes a total of 20 sessions of 30 minutes each, once a week for 12 consecutive weeks, followed by 4 additional sessions once every 15 days for the next 2 months and 4 additional sessions once a month.
4. APP that allows physiotherapy education and monitoring of results.

   * Clinical variables and outcome measures:

The outcome measures will be the POLARS predictive score of the LARS, Vaizey (St. Mark's) of fecal incontinence and the EORTC QLQ-30 of quality of life, obtained perioperatively, and the LARS, Vayzey and QLQ-30 scales at 6 months and year of surgery or closure of the protective stoma. As measurements of the FTSP, the results of the anal manometries, the modified Oxford scale and the PERF scheme will be obtained. Adherence to the FTSP program will be evaluated by the percentage of compliance with the exercises according to the patients' diary or from the records of the pelvic floor app.

To assess the degree of acceptability to the program, the percentage of patients who leave it voluntarily, totally or partially, will be evaluated, as well as using a visual analog scale (VAS) obtained at the end of the program.

The following data will be recorded as clinical variables: 1) sex; 2) age; 3) BMI; 4) date of rectal resection; 5) performance or not of protection stoma and, where appropriate, date of stoma closure; 6) administration or not of radiochemotherapy or neoadjuvant short-course radiotherapy; 7) Height of tumor measured by MRI; 8) Open, laparoscopic, taTME or mixed approach (abdominal part by laparoscopy and open pelvic part); 9) Total or partial mesorectal excision; 10) Quality of mesorectal resection; 11) Height of the anastomosis (from anal margin); 12) type of anastomosis (manual or mechanical, end-to-end or lateral-end or pouch-end); 13) Administration of adjuvant chemotherapy; 14) Postoperative complications according to the Clavien-Dindo classification; 15) Postoperative staging; and 16) Astringent medication, forming fecal mass or hygienic-dietary modifications throughout the study.

RESULTS:

The feasibility and adherence to the program will be initially analyzed through the percentage of compliance with the PTNS sessions and the proposed FSTP exercises performed in the first 15 cases, in order to be able to adjust the program scheme and estimate a representative sample size.

The main objective of the study will be to compare the estimated preoperative LARS score (POLARS) with the postoperative LARS score observed at 6 months and one year after radical surgery (or closure of the ileostomy) for rectal cancer, considering it as clinically relevant descending at least one category from POLARS- major to LARS- minor (or not LARS) in at least 50% of patients. Secondary objectives will be to assess the effect of the interventions on fecal incontinence (Vaizey), quality of life (QLQ-C30) and pelvic floor contractility (anal manometry, Oxford scale and PERF).

Feasibility and Impact of a Prehabilitation and Rehabilitation Program for the Continuity of Care in Severe Low Anterior Resection Syndrome.

Feasibility and Impact of a Trimodal Prehabilitation and Rehabilitation Program to Reduce the Predicted Low Anterior Resection Syndrome After Radical Rectal Cancer Treatment. A Non-Randomized Prospective Study Phase II. PRELARS Study

To analyze the feasibility of the introduction of a multimodal package of integrated interventions (educational, pelvic floor physiotherapy, biofeedback and posterior tibial neurostimulation-PTNS-) with the objective of reducing the severity of predictable intestinal dysfunction after the radical surgery for rectal cancer, measured by the number of patients that complete the treatment.

Compliance comprehensive outpatient therapeutic program, supported by the introduction of an APP device; measured by the proportion of patients that use the APP and the use that gives each patient.

To assess the effect of multimodal interventions on aspects of fecal incontinence, measured by the Vaizey Faecal Incontinence score (Vaizey Score 0-24; 0 perfect continence and 24 is total incontinence).

To analyze the correlation between the estimated preoperative POLARS score and the postoperative LARS score collected at 6 months and one year after radical surgery or closure of the derivative stoma. (LARS score 0-42; 0-20 No LARS; 21-29 Minor LARS; 30-42 Major LARS)

To assess the effect of multimodal interventions on aspects of quality of life, measured by the EORTC QLQ-30 quality of life score (0-100; higher measures mean better quality of life).

To assess the effect of multimodal interventions on pelvic floor contractility with the results of anal manometries, the modified Oxford scale (0-5; 0 means No contraction and 5 means Strong contraction).

Hospital Donostia

PhD; Head of service

Subjects should have received surgery for rectal cancer (low anterior resection).

Subjects should have received curative surgery for rectal cancer (low anterior resection) with/with-out adjuvant (radiation/chemo) therapy.

Low Anterior Resection for Rectum Cancer

Søren T Skou, PhD

Ismail Gögenur, PhD

Background:

Patients treated for rectal cancer are in high risk of developing poor quality of life and faecal incontinence. Faecal incontinence has a negative impact on quality of life. However, there is limited knowledge on how to prevent it. Known exposures are ; age at surgery, gender, tumor height, pre-operative radiotherapy, surgical technique and temporary stoma. In order to evaluate the underlying mechanisms of faecal incontinence, it is central to evaluate the anorectal muscle function for sensory and motor impairment. Exposures representing different constructs in the biopsychosocial model are likewise likely to be associated with quality of life and faecal incontinence. These exposures include sexual dysfunction, urinary incontinence, fatique, physical inactivity and finding meaning in life. There are to our knowledge, no records on these relationships from prior to surgery to 2 years after. These biopsychosocial exposures are central to include when developing strategies that can prevent poor quality of life and faecal incontinence for patients treated for rectal cancer.

Purpose:

The primary purpose of the EDFI-Cohort study is to determine how several variables (surgical technique, anorectal muscle function, faecal incontinence, urinary incontinence, sexual dysfunction, fatigue, physical activity and finding meaning in life) develop over time and predicts quality of life. Secondary how it predicts LARS-score in patients with rectal cancer from prior to surgery to 2 years after primary treatment.

Methods:

We will include subjects diagnosed with rectal cancer and have received curative surgery (low anterior resection) with/without adjuvant (radiation/chemo) therapy. The cohort aim to recruit all eligible patients in a one year period. We estimate to recruit 70 patients.

Self-reported outcomes will be collected with a series of validated questionnaires that subjects will be asked to complete 6 times during the two year study at 3, 6, 12, 26 78 and 104 weeks. Outcomes include: Quality of life using (EORTC QLQ-C30) (primary outcome), (CR29) and (FA12), bowel related quality of life (LARS-score) (secondary outcome), faecal incontinence (Vaizey score), urinary incontinence (ICIQ-UI), (MLUTS/FLUTS) and (MLUTSsex/FLUTSsex), physical activity level from Danish National Health Profile and finding meaning in life (SOME).

Objective measures will be collected at 6 weeks, 6 months, 12 months and 24 months and include: Anorectal manometry that measures anorectal muscle function and rectal perception, a digital examination of anorectal muscle function using the Digital Rectal Examination Scoring System (DRESS) and the six-minute walk test a measure of submaximal exercise capacity.

We plan to analyze the EDFI-Cohort study as repeated measures with both simple and multiple linear regression models for the continuous data. We plan to adjust for known confounders and variables related to treatment.

Determining Early Development of Faecal Incontinence and Anorectal Muscle Function After Surgery for Rectal Cancer.

The EDFI-Cohort: Determining Early Development of Faecal Incontinence and Anorectal Muscle Function After Curative Surgery for Rectal Cancer.

Reseachers whom are interested in study data, are welcome to contact study PI.

International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)

International Consultation on Incontinence Questionnaire - Male/female Lower Urinary Tract Symptoms (ICIQ-MLUTS og ICIQ-FLUTS)

International Consultation on Incontinence Questionnaire - Male/female Sexual Matters associated with Lower Urinary Tract Symptoms (ICIQ-MLUTSsex or ICIQ-FLUTSsex)

European Organisation for Research and Treatment of Cancer's generic core set on quality of life (EORTC QLQ-C30)

European Organisation for Research and Treatment of Cancer's colorectal cancer module (EORTC QLQ-CR29)

European Organisation for Research and Treatment of Cancer's fatigue module (EORTC QLQ-FA12)

European Organisation for Research and Treatment of Cancer's information about disease and treatment module (EORTC QLQ-INFO25)

Maximal resting pressure Maximal squeeze pressure Endurance squeeze - max squeeze pressure or longest time Latency (rate of force development), number of rectal muscle contractions/squeezes in 15 sec test.

Maximal resting pressure Maximal squeeze pressure Maximal squeeze pressure duration

Volume capacity measurements:

Maximal tolerated volume Conscious rectal sensitivity threshold Conscious rectal sensitivity Constant sensation

Self-reported questionnaire - St. Marks Incontinence score (Vaizey score)

Self-reported questionnaire - Low anterior resection symptom - score (LARS-score)

physical activity section of the Danish National Health Profile

Sources of Meaning and Meaning in Life Questionnaire (SoMe)

Zealand University Hospital

Association of Danish Physiotherapists

Slagelse Hospital

Physiotherapist and PhD

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

volumetric modulated moderately fractionated arc therapy

hypofractionated radiotherapy

Joan Lozano, MD

The objective of the study is to determine the incidence of faecal incontinence in prostate cancer survivors treated with moderately hypofractionated radiation therapy and correlate the dose received by the anal sphincter with the degree of faecal incontinence.

The investigators know that high doses of irradiation in the anal sphincter are associated with more chronic fecal leaks in survivors irradiated by normofractionated radiotherapy prostate cancer.

The safe dose of irradiation of the anal sphincter with radiotherapy modern techniques (volumetric modulated arc therapy with moderately hypofracctionation) is unknown.

Urgency and faecal incontinence greatly affects the quality of life of these patients.

Therefore, it is interesting to implement strategies to protect the anatomical structures involved in fecal continence.

The objective of the study is to determine the incidence of faecal incontinence in prostate cancer survivors treated with modern moderately hypofractionated radiation therapy and correlate the dose received by the anal sphincter with the degree of faecal incontinence.

The investigators also want to evaluate the quality of life of these patients

Faecal Incontinence in Prostate Cancer Survivors Treated Whith Radiotherapy

Faecal Incontinence in Prostate Cancer Survivors Treated With Moderately Hypofractionated Radiotherapy

grade of faecal incontinence in prostate cancer patients

grade of faecal incontinence in prostate cancer survivors

Quality of life in prostate cancer survivors comparing continents patients and incontinents patients

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effects of Modified Precision Functional Sphincter-Preserving Surgery (PPS) on Ultralow Rectal Cancer	NCT05245565	Rectum Cancer Stoma Colostomy Faecal Incontin... Leakage, Anasto...		18 Years -	Shanghai 10th People's Hospital
Italian Validation of the LARS Score	NCT04406311	Rectal Cancer		18 Years -	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Feasibility and Impact of a Prehabilitation and Rehabilitation Program for the Continuity of Care in Severe Low Anterior Resection Syndrome.	NCT04612569	Rectal Cancer Low Anterior Re... Faecal Incontin...		18 Years -	Hospital Donostia
Feasibility and Impact of a Prehabilitation and Rehabilitation Program for the Continuity of Care in Severe Low Anterior Resection Syndrome.	NCT04612569	Rectal Cancer Low Anterior Re... Faecal Incontin...		18 Years -	Hospital Donostia
Determining Early Development of Faecal Incontinence and Anorectal Muscle Function After Surgery for Rectal Cancer.	NCT03257332	Rectum Cancer Quality of Life Faecal Incontin... Low Anterior Re...	Low Anterior Re...	18 Years -	Slagelse Hospital
Feasibility and Impact of a Prehabilitation and Rehabilitation Program for the Continuity of Care in Severe Low Anterior Resection Syndrome.	NCT04612569	Rectal Cancer Low Anterior Re... Faecal Incontin...		18 Years -	Hospital Donostia
Italian Validation of the LARS Score	NCT04406311	Rectal Cancer		18 Years -	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Faecal Incontinence in Prostate Cancer Survivors Treated Whith Radiotherapy	NCT04262609	Faecal Incontin... Prostate Cancer	hypofractionate...	18 Years -	Consorci Sanitari de Terrassa

Spots Global Cancer Trial Database for faecal incontinence