The national polyp study design, methods, and characteristics of patients with newly diagnosed polyps Conference Paper


Authors: Winawer, S. J.; Zauber, A. G.; O'Brien, M. J.; Gottlieb, L. S.; Sternberg, S. S.; Stewart, E. T.; Bond, J. H.; Schapiro, M.; Panish, J. F.; Waye, J. D.; Kurtz, R. C.; Shike, M.; Ho, M. N.; National Polyp Study Workgroup
Contributors: Lightdale, C. J.; Edelman, M.; Cohen, A.; Fleisher, M.; McMahan, A. R.; Koskella, K.
Title: The national polyp study design, methods, and characteristics of patients with newly diagnosed polyps
Conference Title: American Cancer Society National Conference on Colorectal Cancer
Abstract: The National Polyp Study (NPS) is a multicenter prospective randomized trial designed to evaluate follow‐up surveillance strategies in patients who have undergone polypectomy for the control of large bowel cancer. The study design was developed by a joint research committee from American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy, and the American College of Gastroenterology. Subjects who met the eligibility criteria were randomized into two different treatment arms. Eligibility criteria included: removal of one or more adenomas; complete colonoscopy; no prior polypectomy, inflammatory bowel disease, or familial polyposis; and no history of colon cancer. The treatment arms consisted of a frequent follow‐up (1 and 3 years after initial polypectomy) and a less frequent follow‐up (3 years). Follow‐up examinations included fecal occult blood tests, air‐contrast barium enema, and colonoscopy. The latter was done on 9112 referred patients at the seven participating centers from November 1980 until February 1990 who had no history of polypectomy, colon cancer, familial polyposis, or inflammatory bowel disease. Of these patients, 4763 (52.3%) had no polyps; 549 (6.0%) had an invasive cancer; 776 (8.5%) had nonadenomatous polyps; 208 (2.3%) had incomplete examinations; 184 (2.0%) had other findings; and 2632 (28.9%) had one or more adenomas, of which 1418 (53.9%) were randomized to one of the two treatment arms. This article reports the background, rationale, objectives, methods, and organization of this study and includes patient characteristics on initial presentation. Future data provided by the NPS may help in the development of recommendations for surveillance guidelines for such patients. This study also provides a framework to address questions regarding the natural history of adenomas and their relationship with colorectal cancer. Copyright © 1992 American Cancer Society
Keywords: adult; controlled study; aged; major clinical study; clinical feature; clinical trial; patient selection; united states; follow up; follow-up studies; prospective studies; demography; randomized controlled trial; colorectal neoplasms; adenoma; colonoscopy; colorectal tumor; evaluation studies; polypectomy; colon polyp; colonic polyps; patient referral; occult blood; sample; colon adenoma; rectum adenoma; barium enema; middle age; enema; rectum polyp; colorectal adenomas; large intestine cancer; barium sulfate; national polyp study; colorectal polyps; human; male; female; priority journal; article; support, u.s. gov't, p.h.s.
Journal Title Cancer
Volume: 70
Issue: Suppl. 3
Conference Dates: 1991 Mar 20-22
Conference Location: New Orleans, LA
ISBN: 0008-543X
Publisher: Wiley Blackwell  
Date Published: 1992-09-01
Start Page: 1236
End Page: 1245
Language: English
DOI: 10.1002/1097-0142(19920901)70:3+<1236::Aid-cncr2820701508>3.0.Co;2-4
PUBMED: 1511370
PROVIDER: scopus
DOI/URL:
Notes: Article -- Export Date: 30 July 2019 -- Source: Scopus
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MSK Authors
  1. Moshe Shike
    168 Shike
  2. Alfred M Cohen
    244 Cohen
  3. Martin Fleisher
    312 Fleisher
  4. Robert C Kurtz
    196 Kurtz
  5. Ann G Zauber
    314 Zauber
  6. Sidney J Winawer
    274 Winawer
  7. May Nah Ho
    13 Ho