The development of a validated instrument to evaluate bowel function after sphincter-preserving surgery for rectal cancer Journal Article


Authors: Temple, L. K.; Bacik, J.; Savatta, S. G.; Gottesman, L.; Paty, P. B.; Weiser, M. R.; Guillem, J. G.; Minsky, B. D.; Kalman, M.; Thaler, H. T.; Schrag, D.; Wong, W. D.
Article Title: The development of a validated instrument to evaluate bowel function after sphincter-preserving surgery for rectal cancer
Abstract: PURPOSE: Sphincter-preserving surgery is technically feasible for many rectal cancers, but functional results are not well understood. Therefore, the purpose of this study was to develop an instrument to evaluate bowel function after sphincter-preserving surgery. METHODS: A 41-item bowel function survey was developed from a literature review, expert opinions, and 59 patient interviews. An additional 184 patients who underwent sphincter-preserving surgery between 1997 and 2001 were asked to complete the survey and quality-of-life instruments (Fecal Incontinence Quality of Life, European Organization for Research and Treatment of Cancer QLQ 30/Colorectal Cancer 38). A factor analysis of variance was performed. Test-retest reliability was evaluated, with 20 patients completing two surveys within a mean of 11 days. Validity testing was done with clinical variables (gender, age, radiation, length of time from surgery), surgical variables (procedure: local excision, low anterior resection, coloanal anastomosis), reconstruction (J-pouch, straight), anastomosis (handsewn, stapled), and quality-of-life instruments. RESULTS: The survey response rate was 70.1 percent (129/184). Among the 127 patients with usable data, 67 percent were male, the median age was 64 (range, 38-87) years, and the mean time for restoration of bowel continuity after sphincter-preserving surgery was 22.9 months. Patients had a median of 3.5 stools/day (range, 0-30), and 37 percent were dissatisfied with their bowel function. Patients experienced a median of 22 symptoms (range, 7-32), with 27 percent reported as severe, 37 percent as moderate, and 36 percent as mild. The five most common symptoms were incomplete evacuation (96.8 percent), clustering (94.4 percent), food affecting frequency (93.2 percent), unformed stool (92.8 percent), and gas incontinence (91.8 percent). The factor analysis identified 14 items that collapsed into three subscales: FREQUENCY (α = 0.75), DIETARY (α = 0.78), and SOILAGE (α = 0.79), with acceptable test-retest reliability for the three subscales and total score (0.62-0.87). The instrument detected differences between patients with preoperative radiation (n = 67) vs. postoperative radiation (n = 15) vs. no radiation (n = 45) (P = 0.02); local excision (n = 10) vs. low anterior resection (n = 55) vs. coloanal anastomosis (n = 62) (P = 0.002); and handsewn (n = 18) vs. stapled anastomosis (n = 99) (P = 0.006). The total score correlated with 4 of 4 Fecal Incontinence Quality of Life (P < 0.01) and 9 of 17 European Organization for Research and Treatment of Cancer subscales (all P < 0.01). CONCLUSIONS: Patients undergoing sphincter-preserving surgery for rectal cancer have impaired bowel function, and those treated with radiation, coloanal anastomoses, or handsewn anastomoses have significantly worse function. This reliable and valid instrument should be used to prospectively evaluate bowel function after sphincter-preserving surgery in patients undergoing rectal cancer therapy. © The American Society of Colon and Rectal Surgeons.
Keywords: adult; controlled study; treatment outcome; aged; aged, 80 and over; middle aged; patient satisfaction; cancer surgery; functional assessment; major clinical study; review; fluorouracil; validation process; cancer adjuvant therapy; cancer radiotherapy; postoperative care; preoperative care; combined modality therapy; radiotherapy, adjuvant; reproducibility of results; quality of life; health survey; information retrieval; cancer research; age; self report; questionnaires; postoperative complications; medical instrumentation; symptom; diet; correlation analysis; disease severity; experience; scoring system; medical society; rating scale; interview; organ preservation; reliability; gender; analysis of variance; rectal neoplasms; intestine function; rectum cancer; rectum resection; rectal cancer; fecal incontinence; anus sphincter; colon anastomosis; surgical stapling; hand; factorial analysis; frequency analysis; feces incontinence; defecation; bowel function; validated instrument; gas
Journal Title: Diseases of the Colon and Rectum
Volume: 48
Issue: 7
ISSN: 0012-3706
Publisher: Lippincott Williams & Wilkins  
Date Published: 2005-07-01
Start Page: 1353
End Page: 1365
Language: English
DOI: 10.1007/s10350-004-0942-z
PUBMED: 15868235
PROVIDER: scopus
DOI/URL:
Notes: --- - "Cited By (since 1996): 35" - "Export Date: 24 October 2012" - "CODEN: DICRA" - "Source: Scopus"
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MSK Authors
  1. Philip B Paty
    496 Paty
  2. Bruce Minsky
    306 Minsky
  3. Jose Guillem
    414 Guillem
  4. Deborah Schrag
    229 Schrag
  5. Martin R Weiser
    532 Weiser
  6. Larissa Temple
    193 Temple
  7. Douglas W Wong
    178 Wong
  8. Howard T Thaler
    245 Thaler
  9. Jennifer M Bacik
    46 Bacik
  10. Michelle Kalman
    1 Kalman