학술논문
Preventive Effects of Bioabsorbable Anti-Adhesion Barriers on Bowel Obstruction After Colectomy in Colon Cancer Patients: A Retrospective Cohort Study Using an Insurance Claims Database.
Document Type
Academic Journal
Author
Iwata R; Global Regulatory Science, Gifu Pharmaceutical University, Gifu, Japan. iwata-risa@pmda.go.jp.; Medical Device Unit, Pharmaceuticals and Medical Devices Agency, Kasumigaseki 3-3-2, Chiyoda-ku, 100-0013, Tokyo, Japan. iwata-risa@pmda.go.jp.; Mochizuki S; Medical Device Unit, Pharmaceuticals and Medical Devices Agency, Kasumigaseki 3-3-2, Chiyoda-ku, 100-0013, Tokyo, Japan.; Hasegawa T; Division of Pharmacoepidemiology, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.; Ishii K; Medical Device Unit, Pharmaceuticals and Medical Devices Agency, Kasumigaseki 3-3-2, Chiyoda-ku, 100-0013, Tokyo, Japan.; Matsumaru N; Global Regulatory Science, Gifu Pharmaceutical University, Gifu, Japan.; Tsukamoto K; Global Regulatory Science, Gifu Pharmaceutical University, Gifu, Japan.
Source
Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: MEDLINE
Subject
Language
English
Abstract
Purpose: Postoperative adhesions can be prevented by the use of bioabsorbable anti-adhesion barriers. Although the occurrence of postoperative bowel obstruction is an important concern for patients, at the time of approval of anti-adhesion barriers, its effectiveness in preventing postoperative bowel obstruction had not been evaluated. We aimed to retrospectively evaluate the incidence of bowel obstruction after colectomy in patients with colon cancer using an insurance claims database.
Methods: This retrospective cohort study analyzed the data of colon cancer patients (between 2005 and 2017 from a national insurance claims database) who underwent colectomies to compare the proportion of individuals with postoperative bowel obstruction between the barrier and no barrier groups.
Results: Of the 587 patients who met the inclusion criteria, 308 and 279 patients were identified as the barrier and no barrier groups, respectively. The incidence of postoperative bowel obstruction was significantly lower in the barrier group (log-rank test, P = 0.0483). The cumulative incidence of postoperative bowel obstruction 37 months after the initial colectomy was 6.1% and 10.9% in the barrier and no barrier groups, respectively. Moreover, consistent results were obtained in the matched cohort.
Conclusion: In colectomies for patients with colon cancer, the use of anti-adhesion barriers could significantly reduce the incidence of postoperative bowel obstruction. Evaluations using insurance claims databases could provide important information on outcomes following implementation of medical devices.
(© 2024. The Author(s), under exclusive licence to The Drug Information Association, Inc.)
Methods: This retrospective cohort study analyzed the data of colon cancer patients (between 2005 and 2017 from a national insurance claims database) who underwent colectomies to compare the proportion of individuals with postoperative bowel obstruction between the barrier and no barrier groups.
Results: Of the 587 patients who met the inclusion criteria, 308 and 279 patients were identified as the barrier and no barrier groups, respectively. The incidence of postoperative bowel obstruction was significantly lower in the barrier group (log-rank test, P = 0.0483). The cumulative incidence of postoperative bowel obstruction 37 months after the initial colectomy was 6.1% and 10.9% in the barrier and no barrier groups, respectively. Moreover, consistent results were obtained in the matched cohort.
Conclusion: In colectomies for patients with colon cancer, the use of anti-adhesion barriers could significantly reduce the incidence of postoperative bowel obstruction. Evaluations using insurance claims databases could provide important information on outcomes following implementation of medical devices.
(© 2024. The Author(s), under exclusive licence to The Drug Information Association, Inc.)