Italian Validation of the LARS Score

NCT04406311 | Completed

• 1 other identifier: LARS21052020
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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%). 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.

Conditions

Rectal Cancer

Keywords

low anterior resection syndrome; Faecal incontinence; Quality of life; Soiling

Outcome Measures

Primary Outcomes (1)

• 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.

  June 2020- August 2020

Secondary Outcomes (2)

• EORTC-QLQ-C30 questionnaire

  June 2020- August 2020

• Single question on QoL

  June 2020- August 2020

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico universitario Agostino Gemelli

Roma, RM, 00168, Italy

Location

Related Publications (16)

• Emmertsen KJ, Laurberg S. Bowel dysfunction after treatment for rectal cancer. Acta Oncol. 2008;47(6):994-1003. doi: 10.1080/02841860802195251.

  PMID: 18607875 BACKGROUND

• Bryant 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.

  PMID: 22935240 BACKGROUND

• Juul 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.

  PMID: 24819098 BACKGROUND

• 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. Ann Surg. 2012 May;255(5):922-8. doi: 10.1097/SLA.0b013e31824f1c21.

  PMID: 22504191 BACKGROUND

• Juul 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.

  PMID: 25807963 BACKGROUND

• Hou 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.

  PMID: 25813530 BACKGROUND

• Samalavicius 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.

  PMID: 26754654 BACKGROUND

• Juul 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.

  PMID: 23598379 BACKGROUND

• Hupkens 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.

  PMID: 29679514 BACKGROUND

• Aaronson 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.

  PMID: 8433390 BACKGROUND

• Fayers 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.

  PMID: 11435060 BACKGROUND

• Klee 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.

  PMID: 10855347 BACKGROUND

• Bregendahl 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.

  PMID: 23581977 BACKGROUND

• Polit 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.

  PMID: 24504622 BACKGROUND

• Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74.

  PMID: 843571 BACKGROUND

• De Simone V, Litta F, Persiani R, Rizzo G, Sofo L, Menghi R, Santullo F, Biondi A, Coco C, Sacchetti F, Longo F, Attalla El Halabieh M, Moroni R, Ratto C. Effectiveness and Validation of the Italian Translation of the Low Anterior Resection Syndrome Score in an Italian High-Volume University Hospital. Front Surg. 2022 Jun 20;9:917224. doi: 10.3389/fsurg.2022.917224. eCollection 2022.

  PMID: 35795231 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Rectal Neoplasms; Low Anterior Resection Syndrome; Encopresis

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Colonic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 23, 2020
• First Posted: May 28, 2020
• Study Start: October 1, 2020
• Primary Completion: November 30, 2020
• Study Completion: December 10, 2020
• Last Updated: December 14, 2020

Record last verified: 2020-12

Locations

IT (1)