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MCC 2011 - Slide 15
 

MCC 2011 - Slide 15

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    MCC 2011 - Slide 15 MCC 2011 - Slide 15 Presentation Transcript

    • Quality of life after rectal surgery Emmanuel Tiret Hôpital Saint-Antoine, AP-HP Université Pierre et Marie Curie, Paris VI
      • WHO
        • An individual’s perception of their position in life in the context of the cultures and value systems in which they live and in relation to their goals, expectations, standarts and concerns.
        • It is a broad ranging concept affected in a complex way by the persons’s physical health, psychological state, personal beliefs, social relationships and their relationship to salient features of their environment.
      • Wikipedia
        • QoL is used in health care to refer to an individual’s emotional, social and physical well being, including their ability to function in the ordinary tasks of living
      Definition of Quality of Life
    • Patient diagnosed with rectal cancer
      • Mean age 67 years, male or female
      • Cancer
      • Rectal cancer (survival, recurrence)
      • Treatment and side effects (stoma, multimodal treatment)
      • Bowel dysfunction +++
      • Sexual impairment ++
    • Quality of life questionnaires Are they adapted to rectal cancer surgery?
      • Medical Outcomes Study Short-Form 36-item questionnaire (MOS SF 36)
      • General health questionnaire
      • EORTC Quality of Life Questionnaire Core-30 item (EORTC QLQ C-30)
        • Generic Cancer questionnaire
      • EORTC Quality of life Questionnaire Colorectal 38-item Questionnaire (EORTC QLQ-CR-38)
      • Colorectal cancer specific module
      • Other scores
      • No specific questionnaire for rectal cancer
    • Medical Outcomes Study Short-Form-36 item questionnaire MOS SF-36 General health questionnaire
      • The SF-36 questionnaire is a generic measure of health that is used to measure quality of life.
      • The 36-item questionnaire accrues scores from eight distinct health domains:
      • Physical functioning assesses limitations to daily activities
      • Role-physical identifies limitations in work or activities caused by physical health
      • Bodily pain grades pain and limitations therefrom
      • General health examines health perception
      • Vitality comprises fatigue and energy scales
      • Social functioning assesses social limitations
      • Role-emotional identifies limitation in work or activities due to emotional health
      • Mental health grades feelings of anxiety and depression
      • These eight scores ranges from 0-100 , with a higher score indicating better health .
      • A difference of 5 points in a particular domain is considered a minimal clinically and socially relevant change, whereas a 10-point difference indicates moderate change.
      • The SF-36 has been shown to have very good internal consistency and correlates well with other quality of life instruments.
    • Medical Outcomes Study Short-Form-36 item questionnaire MOS SF-36 General health questionnaire Non specific for colorectal surgery
    • EORTC Quality of Life Questionnaire Core-30 item (EORTC QLQ C-30) Generic cancer questionnaire
      • 5 functioning scales, 3 symptom scales, 6 single-item measures,
      • 1 global QOL assessment
      • 11 minutes
      • No assistance needed
      • Translated in multiple languages
      • Supplemented by Colorectal module EORTC Quality of life Questionnaire Colorectal 38-item (EORTC QLQ-CR-38)
    • EORTC QLQ C-30 Functioning scales Physical (1-5) 1. Do you have any trouble doing strenuous activities, like carrying a heavy shopping bag or a suitcase? 2. Do you have any trouble taking a long walk? 3. Do you have any trouble taking a short walk outside of the house? 4. Do you need to stay in bed or a chair during the day? 5. Do you need help with eating, dressing, washing yourself or using the toilet? Not at All : 1 A Little : 2 Quite a Bit : 3 Very Much : 4
    • EORTC QLQ C-30 Functioning Scales Role (6,7) Cognitive (20,25)
      • During the past week:
      • 6. Were you limited in doing either your work or other daily activities?
      • 7. Were you limited in pursuing your hobbies or other leisure time activities?
      • 20. Have you had difficulty in concentrating on things, like reading a newspaper or watching television?
      • 25. Have you had difficulty remembering things?
      • Not at All : 1 A Little : 2 Quite a Bit : 3 Very Much : 4
    • EORTC QLQ C-30 Functioning Scales Emotional (21-24), Social (26,27)
      • During the past week:
      • 21. Did you feel tense?
      • 22. Did you worry?
      • 23. Did you feel irritable?
      • 24. Did you feel depressed?
      • 26. Has your physical condition or medical treatment
      • interfered with your family life?
      • 27. Has your physical condition or medical treatment
      • interfered with your social activities?
      • Not at All : 1 A Little : 2 Quite a Bit : 3 Very Much : 4
    • EORTC QLQ C-30 Symptom scales and/or items
      • During the past week:
      • 8. Were you short of breath? (dyspnea)
      • 9. Have you had pain? (pain)
      • 19. Did pain interfere with your daily activities?
      • 10. Did you need to rest? (fatigue)
      • 12. Have you felt weak?
      • 18. Were you tired? (sleep disturbance)
      • 11. Have you had trouble sleeping?
      • 13. Have you lacked appetite?
      • 14. Have you felt nauseated? (nausea and vomiting)
      • 15. Have you vomited?
      • 16. Have you been constipated? (constipation)
      • 17. Have you had diarrhea? (diarrhea)
      • 28. Has your physical condition or medical treatment
      • caused you financial difficulties? (finacial impact)
      • Not at All : 1 A Little : 2 Quite a Bit : 3 Very Much : 4
    • EORTC QLQ C-30 Global quality of life
      • For the following questions please circle the number between 1 and 7 that best applies to you:
      • 29. How would you rate your overall health during the past week?
      • 1 2 3 4 5 6 7
      • Very poor Excellent
      • 30. How would you rate your overall quality of life during the past week?
      • 1 2 3 4 5 6 7
      • Very poor Excellent
      • Functional scales
        • Body image
        • Sexual functioning
        • Sexual enjoyment
        • Future perspective
      • Symptoms scale
        • Micturition problems
        • General gastrointestinal symptoms
        • Defecation problems
        • Stoma-related problems
        • Sexual dysfuntion of males
        • Sexual dysfunction of females
        • Weight loss
      EORTC Quality of life Questionnaire Colorectal 38-item (EORTC QLQ-CR-38)
    • Quality of life after rectal surgery
      • Functional result after sphincter saving resection
      • Impact of preoperative radiotherapy
      • Impact of laparoscopy
      • Sphincter saving procedure versus Abdominoperineal resection
    • Straight Colo-anal Anastomosis
      • Anterior resection syndrome in > 50%
      • increased stool frequency
      • fragmentation or clustering
      • urgency
      • incontinence
    • Colo-anal Anastomosis with a Colonic J-Pouch
      • The benefit of a colonic J pouch has been shown in at least
      • 7 randomised trials 1 and 1 meta-analysis 2
      • Function and quality of life are improved 3
      • The benefit is present immediately after surgery and persists
      • over time 4
      • Halböök et al. Ann Surg 1996; 224: 58-65
      • Heriot et al Br J Surg 2006; 93: 19-32
      • Sailer et al. Br J Surg 2002; 89: 1108-17
      • Harris et al. Br J Surg 2001; 88: 1623-7
    • Functional results at follow-up (55 months) 83 patients with colonic J-pouch Stool frequency (per 24 hours) 2.3 ± 1.3
        • ≤ 2
      50 (60%)
        • 3 to 5
      30 (36%)
        • > 5
      3 (4%) Nocturnal defaecation 24 (29%) Urgency 16 (19%) Pad wear 38 (46%) Intestinal transit regulators 22 (26,5%) Feces-flatus discrimination 21 (25,3%) Stool fragmentation (clustering) 40 (41%) Alimentary restriction 30 (36%)
    • Day:1   Mon Tue   Wed Thurs   Fri Sat   Sun   Bowel diary Michelassi F et al. Arch Surg 1993; 128: 889-94 Day and date Details of bowel function Instructions: Please fill the face of the clock at the time you went to the bathroom for one week (7 days). Fill day and date. On any day please write (see example) B L if you had a liquid stool, B P if you had a pasty stool B F if you had a formed stool. Also write… Sx if you were incontinent of the entire bowel movement Sm if you had a mild to moderate leakage in your underwear or pad E if you went to the bathroom and did not evacuate or E D .if you had difficulty evacuating   Comments on evacuation difficulty or incomplete evacuation
    • Ann Surg 2007; 246: 481-90
      • 364 patients randomized intraoperatively to :
        • coloplasty or straight anastomosis if J-pouch not feasible
        • coloplasty or J-pouch if feasible
    • J-pouch versus coloplasty and straight anastomosis Total daily bowel movemements over 24 months J-pouch vs coloplasty : 0.03 at 4 months 0.03 at 12 months 0.007 at 24 months Ann Surg 2007; 246: 481-90
    • J-pouch versus coloplasty and straight anastomosis Comparison of Fecal Incontinence Severity Index (FISI) over 24 months J-pouch vs coloplasty : 0.001 at 4 months 0.04 at 24 months Ann Surg 2007; 246: 481-90
    • Clustering at 12 and 24 months was more often seen in the CP group than in the J group, but not different in the SA group and CP group Clustering at 24 months CP SA p CP J p Never 7% 16% 0.21 21% 10% <0.03 1-4 / per month 38% 37% 39% 27% >2 per week 22% 22% 20% 24% 1 or >1 per day 33% 25% 20% 39%
    • J-pouch versus coloplasty and straight anastomosis Comparison of Quality of Life with SF-36 Ann Surg 2007; 246: 481-90 No difference at 24 months (score SF 36) Relative insentivity of the SF-36 ??
    • Quality of life at median of 13 years of 97 patients in relation to chemoradiotherapy EORTC QLQ C-30 EORTC QLQ C-38 C Hoerske BJS 2010; 97: 1295-03
    • MRC CR07/NCIC CTG C016 trial PreopRT 25 Gy vs selective postoperative CRT 45 Gy + Fufol Baseline quality of life: no difference RJ Stephens et al. J Clin Oncol 2010
    • MRC CR07/NCIC CTG C016 trial Baseline quality of life
    • MRC CR07/NCIC CTG C016 trial Bowel problems RJ Stephens et al. J Clin Oncol 2010
    • MRC CR07/NCIC CTG C016 trial Unintentional release of stools RJ Stephens et al. J Clin Oncol 2010
    • MRC CR07/NCIC CTG C016 trial Male sexual dysfunction RJ Stephens et al. J Clin Oncol 2010
    • General health No difference RJ Stephens et al. J Clin Oncol 2010
    • Impact of preoperative radiotherapy for rectal cancer on Patients’ Quality of life
      • Increase in sexual dysfunction and aspects of bowel dysfunction
      • However, no evidence of differences in terms of overall physical function or overall quality of life
      • Lack of sensitivity of the quality of life instruments?
      • Adaptation to symptoms?
      • Age of the patients with rectal cancer (67 years), minimizing the impact of sexual dysfunction on health related quality of life?
    • COREAN trial: Laparoscopic versus open rectal resection EORTC QLQ-C30 scores Better physical functioning, less fatigue Lancet Oncol 2010; 1: 637-45 p<0.01 p<0.05
    • COREAN trial: Laparoscopic versus open rectal resection EORTC QLQ-C38 scores Fewer micturition, gastro-intestinal and defecation problems Lancet Oncol 2010; 1: 637-45 p<0.05 p<0.05 p<0.01
    • Quality of life with laparoscopy and open colorectal surgery
      • Meta analyses did not show clinically relevant difference in HRQoL following laparoscopic and open colorectal surgery.
      • There is a trend towards improved QoL outcomes with laparoscopy in early postoperative period.
      • The COREAN study reported a better short-term quality of life after neoadjuvant chemoradiotherapy and laparoscopic rectal resection.
    • APER versus Sphincter-saving procedure EORTC QLQ C-30 function scales 212 patients No significant difference C Schmidt. Ann Surg Oncol 2005; 12: 117-23
    • APER versus Sphincter-saving procedure EORTC QLQ C-30 symptom scales 212 patients C Schmidt. Ann Surg Oncol 2005; 12: 117-23 Symptoms worse in the group of SSR
    • APER versus Sphincter-saving procedure Colorectal cancer specific module scales C Schmidt. Ann Surg Oncol 2005; 12: 117-23 Significant differences
    • Quality of life at median of 13 years of 97 patients in relation to need for a colostomy/ileostomy EORTC QLQ C-30 EORTC QLQ C-38 C Hoerske BJS 2010; 97: 1295-03
      • It is not possible to draw conclusions whether the QoL measures of stoma patients are poorer than for non-stoma patients. However, the results challenge the assumption that people with stoma fare less well than non-stoma patients.
      • There is an additional need for exploring the influence of a wide variety of co-variables and their influence on patients’ QoL.
      • As one cannot expect that randomised trials will be performed in this field, we need large prospective cohort studies in which patients’ QoL measurements are recorded preoperatively and postoperatively.
      Quality of life APER vs Sphincter-saving procedures Pachler J, Wille J Ø rgensenP. Cochrane review 2010
    • Conclusion
      • Lack of specific Score of Quality of Life for patients with rectal cancer.
      • Lack of a standardized tool to assess bowel function in rectal cancer patients.
      • Combining items into subscales can disguise or dilute major important difference in individual item.
      • At baseline, likely related to the presence of tumor, bowel function and quality of life are altered.
      • Patients adapt both physically and psychologically to their postoperative status, and perhaps physical well being which is generally improved is the main determinant of outcome.
      • Surgeons’ view is not representative of patients’ one.
    • Do patients consider preoperative chemoradiotherapy for primary rectal cancer worthwile? Kennedy ED, Cancer 2011 online
    • Do patients consider preoperative chemoradiotherapy for primary rectal cancer worthwile? Kennedy ED, Cancer 2011 online
    • Do patients consider preoperative chemoradiotherapy for primary rectal cancer worthwile? 50 healthy well educated individuals attending screening colonoscopy Kennedy ED, Cancer 2011 online
    • Do patients consider preoperative chemoradiotherapy for primary rectal cancer worthwile? Kennedy ED, Cancer 2011 online
    • Do patients consider preoperative chemoradiotherapy for primary rectal cancer worthwile? 27 patients required a risk of LR≤5% (-10%) before they would choose pre-CRT+surgery Kennedy ED, Cancer 2011 online