Rectal CancerNCT04406311
Italian Validation of the LARS Score
An observational study of Rectal Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
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%). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2020to 10 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a previous diagnosis of rectal neoplasia, who underwent anterior rectal resection surgery with total or partial mesorectal excision (TME or PME) at "Fondazione Policlinico Agostino Gemelli IRCCS" in Rome
Who may be able to join
- rectal neoplasia (between 0 and 15 cm from the anal verge);
- anterior rectal resection surgery with total or partial mesorectal excision (TME or PME) in the period January 2000 - April 2018;
- if a stoma had been created, intestinal continuity must have been restored for at least 24 months (by April 2018);
Who cannot join
- dementia;
- metastatic or recurrent disease;
- other intestinal diseases (including Crohn's disease, ulcerative colitis);
- patients with a stoma or with intestinal continuity restored for less than 24 months;
- patients with problems of understanding the Italian language.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico universitario Agostino Gemelli
Roma, RM, 00168
About this study
Official title: Italian Validation of the Low Anterior Resection Syndrome Score
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.
Read more
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.
Read the detailed description
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Conditions
- Rectal Cancer
- Keywords
- low anterior resection syndrome, Faecal incontinence, Quality of life, Soiling
- Medical subject headings
- Rectal Neoplasms, Low Anterior Resection Syndrome, Encopresis
What is being measured
The primary outcome is the main question the study is designed to answer.
Lars 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.
Measured: June 2020- August 2020
Secondary outcomes (2)
EORTC-QLQ-C30 questionnaire
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.
Measured: June 2020- August 2020
Single question on QoL
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.
Measured: June 2020- August 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start1 Oct 2020
- Primary completion30 Nov 2020
- Study completion10 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Ratto, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406311
- Sponsor's protocol ID
- LARS21052020
- Status last verified
- Dec 2020
- First submitted
- 23 May 2020
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Emmertsen KJ, Laurberg S. Bowel dysfunction after treatment for rectal cancer. Acta Oncol. 2008;47(6):994-1003. doi: 10.1080/02841860802195251.
PubMed 18607875Bryant CL, Lunniss PJ, Knowles CH, Thaha MA, Chan CL. Anterior resection syndrome. Lancet Oncol. 2012 Sep;13(9):e403-8. doi: 10.1016/S1470-2045(12)70236-X.
PubMed 22935240Juul T, Ahlberg M, Biondo S, Espin E, Jimenez LM, Matzel KE, Palmer GJ, Sauermann A, Trenti L, Zhang W, Laurberg S, Christensen P. Low anterior resection syndrome and quality of life: an international multicenter study. Dis Colon Rectum. 2014 May;57(5):585-91. doi: 10.1097/DCR.0000000000000116.
PubMed 24819098Emmertsen 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. Ann Surg. 2012 May;255(5):922-8. doi: 10.1097/SLA.0b013e31824f1c21.
PubMed 22504191Juul T, Battersby NJ, Christensen P, Janjua AZ, Branagan G, Laurberg S, Emmertsen KJ, Moran B; UK LARS Study Group. Validation of the English translation of the low anterior resection syndrome score. Colorectal Dis. 2015 Oct;17(10):908-16. doi: 10.1111/codi.12952.
PubMed 25807963Hou XT, Pang D, Lu Q, Yang P, Jin SL, Zhou YJ, Tian SH. Validation of the Chinese version of the low anterior resection syndrome score for measuring bowel dysfunction after sphincter-preserving surgery among rectal cancer patients. Eur J Oncol Nurs. 2015 Oct;19(5):495-501. doi: 10.1016/j.ejon.2015.02.009. Epub 2015 Mar 23.
PubMed 25813530Samalavicius NE, Dulskas A, Lasinskas M, Smailyte G. Validity and reliability of a Lithuanian version of low anterior resection syndrome score. Tech Coloproctol. 2016 Apr;20(4):215-20. doi: 10.1007/s10151-015-1424-0. Epub 2016 Jan 12.
PubMed 26754654Juul T, Ahlberg M, Biondo S, Emmertsen KJ, Espin E, Jimenez LM, Matzel KE, Palmer G, Sauermann A, Trenti L, Zhang W, Laurberg S, Christensen P. International validation of the low anterior resection syndrome score. Ann Surg. 2014 Apr;259(4):728-34. doi: 10.1097/SLA.0b013e31828fac0b.
PubMed 23598379Hupkens BJP, Breukink SO, Olde Reuver Of Briel C, Tanis PJ, de Noo ME, van Duijvendijk P, van Westreenen HL, Dekker JWT, Chen TYT, Juul T. Dutch validation of the low anterior resection syndrome score. Colorectal Dis. 2018 Oct;20(10):881-887. doi: 10.1111/codi.14228. Epub 2018 May 16.
PubMed 29679514Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.
PubMed 8433390Fayers PM. Interpreting quality of life data: population-based reference data for the EORTC QLQ-C30. Eur J Cancer. 2001 Jul;37(11):1331-4. doi: 10.1016/s0959-8049(01)00127-7. No abstract available.
PubMed 11435060Klee M, Groenvold M, Machin D. Using data from studies of health-related quality of life to describe clinical issues examples from a longitudinal study of patients with advanced stages of cervical cancer. Qual Life Res. 1999 Dec;8(8):733-42. doi: 10.1023/a:1008903818379.
PubMed 10855347Bregendahl S, Emmertsen KJ, Lous J, Laurberg S. Bowel dysfunction after low anterior resection with and without neoadjuvant therapy for rectal cancer: a population-based cross-sectional study. Colorectal Dis. 2013 Sep;15(9):1130-9. doi: 10.1111/codi.12244.
PubMed 23581977Polit DF. Getting serious about test-retest reliability: a critique of retest research and some recommendations. Qual Life Res. 2014 Aug;23(6):1713-20. doi: 10.1007/s11136-014-0632-9. Epub 2014 Feb 7.
PubMed 24504622Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74.
PubMed 843571
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Validation of the Low Anterior Resection Syndrome Score
- ClinicalTrials.gov ID
- NCT04406311
- Acronym / sponsor ID
- LARS21052020
- Conditions
- Rectal Cancer
- Keywords
- low anterior resection syndrome, Faecal incontinence, Quality of life, Soiling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a previous diagnosis of rectal neoplasia, who underwent anterior rectal resection surgery with total or partial mesorectal excision (TME or PME) at "Fondazione Policlinico Agostino Gemelli IRCCS" in Rome
Key inclusion criteria (3 listed)
- rectal neoplasia (between 0 and 15 cm from the anal verge);
- anterior rectal resection surgery with total or partial mesorectal excision (TME or PME) in the period January 2000 - April 2018;
- if a stoma had been created, intestinal continuity must have been restored for at least 24 months (by April 2018);
Key exclusion criteria (5 listed)
- dementia;
- metastatic or recurrent disease;
- other intestinal diseases (including Crohn's disease, ulcerative colitis);
- patients with a stoma or with intestinal continuity restored for less than 24 months;
- patients with problems of understanding the Italian language.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lars score
Time frame: June 2020- August 2020
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.
2 secondary outcomes
EORTC-QLQ-C30 questionnaire
Time frame: June 2020- August 2020
Single question on QoL
Time frame: June 2020- August 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
- Background: PubMed 18607875Emmertsen KJ, Laurberg S. Bowel dysfunction after treatment for rectal cancer. Acta Oncol. 2008;47(6):994-1003. doi: 10.1080/02841860802195251.
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- Background: PubMed 24819098Juul T, Ahlberg M, Biondo S, Espin E, Jimenez LM, Matzel KE, Palmer GJ, Sauermann A, Trenti L, Zhang W, Laurberg S, Christensen P. Low anterior resection syndrome and quality of life: an international multicenter study. Dis Colon Rectum. 2014 May;57(5):585-91. doi: 10.1097/DCR.0000000000000116.
- Background: PubMed 22504191Emmertsen 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. Ann Surg. 2012 May;255(5):922-8. doi: 10.1097/SLA.0b013e31824f1c21.
- Background: PubMed 25807963Juul T, Battersby NJ, Christensen P, Janjua AZ, Branagan G, Laurberg S, Emmertsen KJ, Moran B; UK LARS Study Group. Validation of the English translation of the low anterior resection syndrome score. Colorectal Dis. 2015 Oct;17(10):908-16. doi: 10.1111/codi.12952.
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- Background: PubMed 23598379Juul T, Ahlberg M, Biondo S, Emmertsen KJ, Espin E, Jimenez LM, Matzel KE, Palmer G, Sauermann A, Trenti L, Zhang W, Laurberg S, Christensen P. International validation of the low anterior resection syndrome score. Ann Surg. 2014 Apr;259(4):728-34. doi: 10.1097/SLA.0b013e31828fac0b.
- Background: PubMed 29679514Hupkens BJP, Breukink SO, Olde Reuver Of Briel C, Tanis PJ, de Noo ME, van Duijvendijk P, van Westreenen HL, Dekker JWT, Chen TYT, Juul T. Dutch validation of the low anterior resection syndrome score. Colorectal Dis. 2018 Oct;20(10):881-887. doi: 10.1111/codi.14228. Epub 2018 May 16.
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- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lars score (time frame: June 2020- August 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04406311, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2020.