WHAT IS LARS? LOW ANTERIOR RESECTIONSYNDROME Sophie Pilkington Colorectal Surgeon University Hospital Southampton
INTRODUCTION UK Bowel cancer 2013 41,100 new cases
INTRODUCTION UK Bowel cancer 2013 41,100 new cases Major improvements in surgical and oncological treatment
INTRODUCTION UK Bowel cancer 2013 41,100 new cases Major improvements in surgical and oncological treatment Increased survival rate
PATIENT EXPECTATION Ø Cancer cure Ø Quality of Life Rectal function Sexual function Bladder function
LOW ANTERIOR RESECTION SYNDROME Anal incontinence Emptying difficulties Frequency Urgency Precise definition and incidence? Risk factors? Treatment? Ø Preoperative or baseline bowel function
WHAT IS LARS? Sensible questions Published questionnaires Development of specific questionnaire
WHAT IS LARS? Anorectal physiology Morphological changes Defined by endoanaluss, CT, Proctography?
FUNCTIONAL RESULTS AFTER LOW ANTERIOR RESECTION Karanjia, Schache, Heald BJS 1992; 79: 114-116 Personal series 232 anterior resections over 10 years Compared stapled anastomosis at 3cm (n=26) and 6cm (n=42) Ø Frequency of defaecation Ø Differentiating wind and bowel motion Ø Hold urge for 15mins Ø Soiling
FUNCTIONAL RESULTS AFTER LOW ANTERIOR RESECTION Deterioration in function in both groups NB retrospective assessment of preoperative function Preservation distal rectum in 6cm group Improved Ability to defer call to stool Soiling
RECTAL FUNCTION BEFORE ANTERIOR RESECTION UK Department of Health Criteria for high risk of colorectal cancer Persistent change in bowel habit to looser stools or increased frequency of defaecation in patients older than 60 years
SOUTHAMPTON STUDY 120 patients undergoing major rectal resection for suspected cancer Assessment of continence with Cleveland Clinic score Gender Male 71 (59%) Female 50 (41%) Radiotherapy None 85 (70%) Short 19 (16%) Long 17 (14%) Temporary Ileostomy 48 (40%) Age Years 67 years Incontinence CCI 4 Physiology MRP 60mmHg MSP 112mmHg
SOUTHAMPTON STUDY Cleveland Clinic Incontinence score (Wexner DCR 1993) Never <1/month <1/week <1/day Every day Solid stool 0 1 2 3 4 Liquid stool 0 1 2 3 4 Flatus 0 1 2 3 4 Requires pad 0 1 2 3 4 Lifestyle restriction 0 1 2 3 4
SOUTHAMPTON STUDY Before surgery 45% no anal incontinence 17% severe anal incontinence Ø Risk factor for 1 year
SOUTHAMPTON STUDY Before surgery 45% no anal incontinence 17% severe anal incontinence Ø Risk factor for 1 year Severe anal incontinence over first year 27% at 3 months Ø 59% got better Ø 41% severe anal incontinence at 1 year
SOUTHAMPTON STUDY Before surgery 45% no anal incontinence 17% severe anal incontinence Ø Risk factor for 1 year Severe anal incontinence over first year 27% at 3 months Ø 59% got better Ø 41% severe anal incontinence at 1 year At one year 13/89 (15%) severe anal incontinence
DEFINING ANTERIOR RESECTION SYNDROME Symptom scoring systems Quality of life scoring systems Specific questionnaires
DEFINING ANTERIOR RESECTION SYNDROME Symptom scoring systems Cleveland Clinic Wexner Score (1993) Fecal Incontinence Severity Index (FISI 2004) Vaizey Score (1999) Quality of life scoring systems Specific questionnaires
DEFINING ANTERIOR RESECTION SYNDROME Symptom scoring systems Cleveland Clinic Score (Wexner 1993) Fecal Incontinence Severity Index (FISI 2004) Vaizey Score (1999) Quality of life scoring systems SF-36 (Ware 1992) or EQ5D (1990) EORTC QLQ-CR39 (2009) FIQL (Rockwood 2000) Specific questionnaires
DEFINING ANTERIOR RESECTION SYNDROME Symptom scoring systems Cleveland Clinic Score (Wexner 1993) Fecal Incontinence Severity Index (FISI 2004) Vaizey Score (1999) Quality of life scoring systems SF-36 (Ware 1992) or EQ5D (1990) EORTC QLQ-CR39 (2009) FIQL (Rockwood 2000) Specific questionnaires MSKCC bowel function instrument (Temple 2005) LARS (2012)
MSKCC BOWEL FUNCTION INSTRUMENT Temple et al DCR 2005; 48: 1353-1365 18 item questionnaire 184 patients sent questionnaire 70% response rate 129 completed questionnaires
MSKCC BOWEL FUNCTION INSTRUMENT Temple et al DCR 2005; 48: 1353-1365 5 most common symptoms Incomplete evacuation Clustering Food affecting frequency Un-formed stool Flatus incontinence
Asymptomatic patient
LARS SCORE Emmertsen and Laurberg Annals of Surgery 2012 Vol 255 (5): 922-928 Draft questionnaire Danish rectal cancer survivors 2009 Item selection Validity testing Final bowel function questionnaire: LARS score
LARS SCORE Development of basic questionnaire Literature review Draft questionnaire: 27 questions Inclusion of published scoring systems Wexner score, St Marks incontinence score, Cleveland clinic constipation score Additional relevant questions eg FISI, FIQL Expert review Pilot testing Test-Retest reliability Semistructured interviews
LARS SCORE Anchor question Overall how much is your quality of life affected by your bowel dysfunction? ü Not at all ü A little ü Some ü A lot
PATIENT CHARACTERISTICS Participants n = 1143 All had undergone low anterior resection 2 to 8 years earlier 92.8% responded (n = 1061) 42 had reoperation with permanent colostomy Total 961 completed draft questionnaire 405 (42%) women Mean age 68.5 (range 36 to 93 years) Mean follow up 55.5 months (range 24 to 96) 573 (60%) underwent TME
LARS SCORE Anchor question Item selection and score developed on the basis of questionnaire results from a randomly selected half of the study population N = 483
LARS SCORE Anchor question Item selection and score developed on the basis of questionnaire results from a randomly selected half of the study population N = 483 Validity Tested on the other half of the study population N = 478
ITEM SELECTION Development group (n=482) 5 most important items Incontinence for flatus Incontinence for liquid stool Frequency of bowel motions Clustering of stools Urgency Significant correlation to impact on quality of life Calculated importance & occurrence of each item
VALIDATION Validation group (N=478) No impact on quality of life reported (n=121) LARS score 13 Minor impact (n=164) LARS score 23 Some / major impact (n=193) LARS score 33 Significant difference between all groups (P<0.001)
LARS SCORE QUESTIONNAIRE Clear instructions
LARS SCORE Emmertsen and Laurberg Annals of Surgery 2012
LARS SCORE Designated score 0 to 42 No LARS 0-20 Minor LARS 21-29 Major LARS 30-42
LARS SCORE Quick and easy to use Valid Specific for population of rectal cancer survivors Includes bowel emptying difficulties and urgency Incorporates bother caused by symptom rather than just incidence Score is based on calculated importance of each item and occurrence, rather than a linear scale Rigorous methodology Developed in one population, validated on separate similar population High response rate 93%
LARS SCORE Daily clinical practice Scientific study
VALIDATION OF ENGLISH TRANSLATION Juul et al Colorectal Disease 2015 17, 908-916 12 UK centres Data collection July 2013 to February 2014 Participants Rectal cancer at 0 to 15cm from anal verge Surgery with partial or total mesorectalexcision January 2001 to January 2012 and bowel continuity for at least 12 months
VALIDATION OF ENGLISH TRANSLATION Postal questionnaire EORTC QLQ-C30 LARS score Anchor question for validation: overall how much does your bowel function affect your quality of life? Not at all Very little Somewhat A lot
VALIDATION OF ENGLISH TRANSLATION Response rate 463 / 579 (80%)
VALIDATION OF ENGLISH TRANSLATION
VALIDATION OF ENGLISH TRANSLATION Discriminative variability
LARS BOWEL DYSFUNCTION Bregendahl et al CRD 2013: 15, 1130-1139 Danish rectal cancer registry Major LARS 41% Associated with Neoadjuvant therapy (independent of preoperative radiotherapy regime) Total mesorectal excision Anastomotic leakage Age <= 64 years Female gender 64% minor LARS 3% no LARS
LARS BOWEL DYSFUNCTION But No baseline scores: LARS score in preoperative patients is unknown Emphasis on flatus incontinence Anchor question
ACPGBI 2016 ORAL PRESENTATION Lynes, Thaha Multicentre study Response rate 53% Ø 41% Major LARS Ø 22% Minor LARS Ø 37% No LARS 1093 patients Risk factors Neoadjuvant chemotherapy Female gender Open surgery
LOW ANTERIOR RESECTION SYNDROME LARS score assessment of bowel dysfunction Daily clinical practice Scientific study
LOW ANTERIOR RESECTION SYNDROME LARS score assessment of bowel dysfunction Daily clinical practice Scientific study But No baseline scores: LARS score in preoperative patients is unknown Emphasis on flatus incontinence Anchor question Anorectal physiology Other tests: endoanal USS, CT or proctography
LOW ANTERIOR RESECTION SYNDROME Persistent problems with anal incontinence, urgency and frequency of defaecation (fragmented) following anterior resection Negative impact on quality of life for rectal cancer survivors LARS score: symptom-based scoring system correlated with quality of life