Affiliation:
1. Pharmaceuticals and medical devices agency
2. Gifu Yakka Daigaku
Abstract
Abstract
Purpose
Postoperative adhesions can be prevented by the use of bioabsorbable anti-adhesion barriers. Patient-focused development is a worldwide requirement, but its implementation in medical device development is not sufficient. 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 colectomy 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.
Conclusion
In colectomy 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 to achieve patient-focused evaluation of medical devices.
Publisher
Research Square Platform LLC