Quality-of-life assessment after ileoanal pull-through for ulcerative colitis and familial adenomatous polyposis

Quality-of-Life Ulcerative By Robert

C. Shamberger,

Assessment After Colitis and Familial

Bruce J. Masek, Alan M. Leichtner, Boston, Massachusetts

Background/Purpose: The ileoanal pull-through procedure (IAP) is gaining increasing favor and use in the surgical treatment of children with ulcerative colitis (UC) and familial adenomatous polyposis (FP). Although physiological studies have been performed to assess the outcome of these children, no long-term quality-of-life assessment after the procedure has been performed. Methods: Forty-three patients were identified who had an IAP at our institution in the last 10 years and were at least 6 months postsurgery. Thirty-four were contacted, and 32 agreed to participate in the survey, which was approved by the Human Studies Committee. Participants completed the standardized Medical Outcome Study Short Form-36 (SF-36), which has well-established normative values. Several supplemental questions were prepared in a similar format dealing with issues specific to the ileoanal pull-through procedure. Results: Of the 32 participants, 19 (59%) were girls and 26 (81%) had ulcerative colitis. Mean age at the time of survey was 18.1 years with 12 less than 18 years and 20 218 years. Data from the latter group could be compared with national normative values for this age. The study group was not statistically different from age-appropriate US population

T

HE ILEOANAL PULL-THROUGH procedure has been used extensively in children and young adults since Martin reported successful results from the method in 1977. Good physiological’ and functional result@ have been reported in the pediatric population, but no quality-of-life analysis has been performed. MATERIALS

AND

METHODS

Forty-three patients were identified who underwent an ileoanal pull-through procedure at our institution by previously described methods in the last 10 years and who were at least 6 months postsur;?cry.’ Thirty-four were aucce\sfully contacted, and 32 agreed to participate in the survey. which was approved by the Committee on Clinical Investigation at Children‘s Hospital. Consent wax given by the patients and by the parents of minor children. Nineteen patients 159%) were girls. 76 (81%) had ulcerative colitis, and six ( 19%) had familial polyposis. Patient characteristics are summarized in Table I, Participants completed the standardized Medical Outcomes Study Short Form-36 (SF-36). a widely accepted tool that has well-established normative values.” The SF-36 is a 36.item self-report measure of physical, social. and psychological functioning and well being. Quality of Itfe i\ reflected in an eight-scale profile: physical functioning. role limitations-physical. general health. bodily pain (physical health dimension). vitality. social functioning, role limitations+emotional. and men tal health (mental health dimension). Scale scores range from 0 to 100. A better health status i\ indicated by a higher score. We compared the Journal

ofPediatric

Surgery,

Ileoanal Pull-Through for Adenomatous Polyposis

Vol 34, No 1 (January),

1999: pp 163-166

Harland

S. Winter,

and

Craig

W. Lillehei

normal values on all assessable scales of physical and mental health in the SF-36 survey including physical functioning, role limitations-physical, bodily pain, general health, vitality, social functioning, role limitations-emotional, and mental health (all P> .05 or mean difference SD units 10.8). The supplemental questionaire demonstrated little adverse effect of the surgery. There was limited consumption of medications to control bowel frequency and little restriction of activity because of the frequency of bowel movements or fear of incontinence. The surgical scar was the sole negative factor of significance. Conclusions:The ileoanal pull-through procedure is an excellent surgical option for children with ulcerative colitis or familial adenomatous polyposis, and it produced minimal, if any, adverse effects on their long-term quality of life. J Pediatr Surg ders Company.

INDEX WORDS: ial adenomatous study SF-36.

34:163-166.

Copyright

lleoanal pull-through, polyposis, quality

o

1999

by

W.B.

Saun-

ulcerative colitis, familof life, medical outcomes

SF-36 scale score means for the study sample of the 70 patients who were 18 years of age or older with the means for the same age group from the general US population using a one-tail I test.” We also transformed the mean differences in each scale score into SD units as recommended by Moateller et al. “I According to conventional standards. differences of 0.8 SD units or larger can be considered Ggnihcant.” The SF-36 scale scores were compared between the 20 patients who wfere I8 years of age or older and the 12 children under 18 years of age using the two-tail I test. A comparison of the frequency of concealing the surgical scar between boys and girls was performed with the two-tail t test. A supplement to the SF-36 questionaire was also completed by all participants. Questions were in the same format as the SF-36 queationaire and dealt with issues specific to the ileoanal pull-through identified in prior interviews and follow-up of patients including continence. stool frequency. medications. and surgical scars.

163

164

SHAMBERGER

Table

1. Patient

Variable

NO.

Table 3. Patient

SD

Percent

32 32

13.6 18.1

4.1 5.0

12 20

13.1 20.8

3.5 2.8

32 32

4.5 4.3

2.8 2.8

3-20 5-28 38 62

(yr) 0.75-10.3 0.50~10.1

The results of the SF-36 survey of the 20 patients who were 18 years of age or older at the time of evaluation are shown in Table 2. They reported no differences in the eight scales (one-tail t test; P > .lO). Transforming mean differences (sample mean minus norm group mean) for each scale into SD units resulted in no differences greater than 0.25 SD units, whereas the cutoff for significant difference is 0.8 SD, further evidence from a more conservative statistical method that our sample perceives their health-related quality of life to be no different from US age-related normal values. National normative values have not been established for individuals under 18 years of age. However, there were no differences in mean SF-36 scale scores between the group of 12 children under 18 years and those 18 years or older (two-tail t test, P > .lO). The results of our supplemental questionaire dealing with specific issues pertinent to the ileoanal pull-through procedure are summarized in Table 3. The majority of patients are not taking any medications to control the frequency of their bowel movements, and those who do, take only what they rate as a small or moderate amount. There is essentially no limitation of activities by this Differences General

in SF-36 Scale US Population

Scores

Ages

Sample Mean*

95% Cl

Physical functioning Role-physical

96.5 86.2

93.5 to 99.5 71.3 to 100

Bodily pain General health Vitality

85.7 73.2 60.5

Social functioning Role-emotional Mental health

79.2 88.3 70.6

77.9 to 62.2 to 49.8 to 68.lto

01001

NOTE. standard

Symptoms

and Symptom

General US population deviations (n = 173).

Compared

t4.4 -2.9 +4.9

93.4 84.1 71.2 90.3

-3.5 -2.0 -4.6

77.9 to 98.8 60.1 to 80.1

-4.1

ages

+0.23 -0.19 -0.10 -0.22 +0.17 -0.22

18 to 24 SF-36 scale

US population

ages

SD

Unit* +0.24 -0.11

t5.3

*Patients older than or equal to 18 Years (n = 20). tDifference between sample mean and US normative mean. *Difference divided by general standard deviation (n = 1731. Data from Ware et al.9

With

18-24 Mean Differencet

means

Yes

No

Little

Moderate

ALot

6

25

3

3

0

1

30

1

0

0

10

21

6

1

3

7

24 19 7

1. Have You used medication in the past 4 weeks to control bowel

5-17 18-28

RESULTS

SF-36 Scale

of Current Management

Question

movements? If Yes, how much medication? 2. Did You limit activity in the past 4 weeks

for fear of bowel

If Yes, how ited?

Table 2. Mean

Self-Report

Range

Patient Response (n = 31)

Age (Yr) At time of surgery At time of survey cl8 218 iTme since surgery Pull-through Closure

Characteristics Mean

ET AL

and

population 18 to 24 scale

much

3. Did the number ments interfere

were

of bowel movewith daily activity

in the past 4 weeks? much? 4. Do You conceal

accident? You lim-

If, Yes, how

Your surgical

scar? 5. Are You dissatisfied

with Your

body image? 6. If Yes, because

of bowel

disease?

12 2*

7. If Yes, because

of surgical

scar?

9*

*One

patient

did not respond

to questions

3 6 and 7.

group for fear of bowel accidents and limited interference of daily activity because the number of bowel movements. Seven of the patients admit to concealing their surgical scars and 12 were not satisfied with their body image related primarily to the surgical scar. There was a trend toward higher frequency of concealment of the surgical scar in the girls (P < .lO). DISCUSSION

The importance of assessment of quality-of-life issues for determination of successful outcome in health care is increasingly accepted.r2 These issues are particularly relevant in inflammatory bowel disease in which the alternatives are chronic medical therapy with bowel dysfunction or surgical intervention with its potential sequelae.t3 Previously reported analyses in adults have compared populations of patients treated with chronic medical therapy versus those who undergo surgery. They have suggested that the patients who undergo ileoanal pull-through procedures do as well if not better than the chronic colitis group.14,15Kohler et alI6 compared adults with ileoanal pull-through with a group of controls who had a cholecystectomy performed. They found the quality of life and performance scores were similar between these two groups. Evaluations in adults also have compared the quality of life of patients who have undergone various operations including proctocolectomy with a Brooke ileostomy or Kock pouch with those with an ileoanal pull-through. These studies have shown that the latter procedure resulted in higher quality-of-life ratings,r’-r9 although some studies have suggested that this difference is limited.‘O Awad et al” evaluated a group of

QUALITY

OF LIFE AFTER

ILEOANAL

PULL-THROUGH

165

adults who underwent colectomy and Brooke ileostomy and found a remarkable adaptation to life with an ileostomy and a preference to continue with the ileostomy rather than proceed with a restorative ileoanal pull-through procedure. Weinryb et al” found that the major improvement in quality of life in adults with colitis resulted from colectomy, and a lesser improvement resulted from the ileoanal pull-through procedure. Provenzale et alZ3recently have completed an evaluation of adults who underwent ileoanal pull-through procedure for ulcerative colitis. Evaluation by the SF-36 was correlated with several other tools including the Sickness Impact Profile (SIP), Rating Form of Inflammatory Bowel Disease (IBD), Patients Concerns (RFIPC), and the time trade-off (TTO), which all assess healthrelated quality-of-life issues. The validity of these methods was confirmed by the close correlation between appropriate scales in the various tools. The quality of life of adults after the ileoanal pull-through procedure was found to be better than that of a national sample of patients with inflammatory bowel disease and that it was similar to that of a normal population by the SF-36, findings similar to those in our cohort. The SF-36 survey has been validated previously for evaluation of surgical results in adult populations. These studies have applied the survey before and after surgery in such diverse areas as coronary artery bypass. hemorrhoidectomy, cholecystectomy, herniorrhaphy. Rouxen-Y bypass for obesity, and debridement for necrotizing

pancreatitis.‘4,Z5 In these studies the tool has generally shown a marked improvement in quality of life in many of the survey’s scales. Quality of life assessment has not been reported previously in individuals who underwent an ileoanal pull-through procedure in childhood or adolescence. In this analysis, we did not compare the cohort after surgery with individuals with colitis, as had been done in many of the preceding adult studies, but with a healthy agematched US population. The results are even more striking in that the study group rated themselves equal to the US normal values. This is strong support for the use of the ileoanal pull-through procedure for children with medically intractable ulcerative colitis and for familial adenomatous polyposis. The supplemental questionaire was designed to address specific issues that may arise after an ileoanal pull-through procedure including stool frequency, continence, medications taken to control bowel frequency. and the surgical scar. This portion of the questionaire also demonstrated little adverse effect of the surgery on the quality of life of the respondents. There was limited consumption of medications to control bowel frequency, and little restriction of activity because of the fear of bowel accidents or the frequency of bowel movements. Twenty-three percent of the respondents attempt to conceal their surgical scars from others, and the majority of the 39% who are not satisfied with their body image attribute this to their surgical scar.

REFERENCES I. Shamberger RC, Lillehei CW, Nurko S, et al: Anorectal function in children after ileoanal pull-through. J Pediatr Surg 29:329-333, 1994 2. Odigwe L. Sherman PM. Filler R. et al: Straight ileoanal snastomosis and ileal pouch-anal anastomosis in the surgical management of idiopathic ulcerative colitis and familial polyposis coli in children: Follow-up and comparative analysis. J Pediatr Gastroenterol Nutr 6:4X419. 1987 3. C‘oran AC: A personal experience with 100 consecutive total colectomiea and straight ileoanal endorectal pull-throughs for benign disease of the colon and rectum in children and adults. Ann Surg 2 12:212-218, I990 3. Telander RL. Spencer M. Perrault J. et al: Long-term followup of the ileoanal anastomosis in children and young adults. Surgery 108:717725. lYY0 5. Fonkalsrud EW. Loar N: Long-term results after colectomy and endorcctal ileal pullthrough procedure in children. Ann Surg 215:57-62, 1992 6. Davis C. Alexander F. Lavery I. et al: Results of mucosal proctectomy versus extrarectal dissection for ulcerative colitis and familial polyposis in children and young adults. J Pediatr Surg ‘9:X)5-309. 1991 7. Rintala RJ. Lindahl H: Restorative proctocolectomy for ulcerative colitis in children-Is the J-pouch better than straight pull-through? J Pediatr Surp 3 1530.533. 1996 8. Romanos J. Stebbing JF. McC. Mortensen NJ McC, et al:

Restorative proctocolectomy in children and adolescents. J Pediatr Surg 31:1655-1658. 1996 9. Ware JE, Snow KK, Kosinski M. et al: SF-36 Health Survey Manual and Interpretation Guide. Boston, MA, New England Medical Center. The Health Institute, 1993 10. Mosteller E Ware JE. Levine S: Final panel: Comments on the conference on advances in health status assessment. Medical Care 27:S282-294. 1989 11. Cohen J: Statistical Power for the Behavioral Sciences. Hillsdale. NJ. Lawrence Earlbaum Associates, 1988 12. Testa MA. Simonson DC: Assessment of quality-of-life outcomes. N Engl J Med 334:835-840. 1996 13. Ktinsebeck HW, Kijrber J, Freyberger H: Quality of life in patients with inflammatory bowel disease. Psychother Psychosom S4:110-116, 1990 14. McLeod RS. Churchill DN. Lock AM, et al: Quality of life of patients with ulcerative colitis preoperatively and postoperatively. Gastroenterology IO1 : I307- I3 13, 199 1 15. Sagar PM. Lewjis W. Holdsworth PJ. et al: Quality of life after restorative proctolectomy with a pelvic ileal reservoir compares favorably with that of patients with medically treated colitis. Dis Colon Rectum 36:584-593. 1993 16. Kiihler LW. Pemberton JH. Hodpe DO. et al: Long-term functional results and quality of life after ileal pouch-anal anastomosis and cholecystectomy. World J Surg 16: 1116-l 131. 1992 17. Pemberton JH, Phillips SF. Ready RR. et al: Quality of life after

SHAMBERGER

Brooke ileostomy and ileal pouch-anal anastomosis. Ann Surg 209:620628, 1989 18. Skarsgard ED, Atkinson KG. Bell GA. et al: Function and quality of life results after ileal pouch surgery for chronic ulcerative colitis and familial polyposis. Am J Surg 157:467-47 1, 1989 19. Kohler LW, Pemberton JH, Zinsmeister AR, et al: Quality of life after proctocolectomy: A comparison of Brooke ileostomy, Kock pouch, and ileal pouch-anal anastomosis. Gastroenterology lOl:679-684, I99 I 20. Kiihler L. Troidl H: The ileoanal pouch: A risk-benefit analysis. Br J Surg 82:443-447. 1995 21. Awad RW, El-Gohary TM. Skilton JS. et al: Life quality and p sychological morbidity with an ileostomy. Br J Surg 80:252-253. 1993

ET AL

22. Weinryb RM, Gustavsson JP, Liljeqvist L, et al: A prospective study of the quality of life after pelvic pouch operation. J Am Coll Surg 180:589-595, 1995 23. Provenzale D, Shearin M, Phillips-Bum BG. et al: Health-related quality of life after ileoanal pull-through: Evaluation and assessment of new health status measures. Gastroenterology 113:7-13, 1997 24. Temple PC, Travis B, Sachs L, et al: Functioning of patients before and after elective surgical procedures. I : 17-25. 1995

and well-being J Am Co11 Surg

25. Burney RE. Jones KR. Coon JW. et al: Core outcomes measures for inguinal hernia repair. J Am Coil Sug 185509.515, 1997

Discussion K. Georgeson (Birmingham, AL): I enjoyed the paper. I did not hear whether you did a J pouch or just a straight pipe, or did you do both, and if so, were there differences between the two? R.C. Shamberger (response): All of our patients had J pouches so we could not look at any difference between the straight or the J pouch. D. Wesson (Houston, 7x): First, I would like to compliment Bob for doing this study. I think that our specialty needs to do more work along these lines. I have another technique question. It has to do with the technique that you use for doing the dissection. Did you do a typical endorectal dissection the way we do for Hirschsprung’s disease or did you do a total proctectomy with the double stapled anastomosis that the adult colorectal surgeons now seem to be favoring? R.C. Shamberger (response): These were all done with a mucosal endorectal dissection performed primarily from the distal end of the anus.

D. Wesson: Do you have any comments or thoughts about the functional outcomes comparing those two techniques? R.C. Shamberger (response): We cannot comment because we do not have any patients who were stapled. We have had very good success with this technique, so we have not switched over to the stapled method. A. Hebra (Charleston, SC): I enjoyed your presentation Dr Shamberger. That is great work. I would like you to comment, given your final observation that the surgical scar has such a major impact on these children, would you recommend that we should proceed with doing more of these operations using a minimally invasive technique. R.C. Shamberger (response): That conclusion could certainly be drawn from our results. A limited number of patients felt that the surgical scar was a significant concern, and doing this procedure through a laparoscopic technique would obviate that issue, but we have not adopted that technique.