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A Randomized Controlled Trial of Thermo-Sensitive Sol–Gel Anti-Adhesion Agent after Gynecologic Surgery
- Source :
- Journal of Clinical Medicine, Vol 9, Iss 7, p 2261 (2020)
- Publication Year :
- 2020
- Publisher :
- MDPI AG, 2020.
-
Abstract
- Postoperative abdominal adhesions can lead to several adverse consequences such as pelvic pain, bowel obstruction, and infertility. We aimed to explore the anti-adhesion efficacy and safety of a thermo-sensitive sol–gel agent in patients who receive abdominopelvic surgery for benign gynecologic disease. This study was a randomized, controlled, single-blind clinical trial of women undergoing benign gynecologic surgery between January 2017 and December 2017. The patients were randomly assigned to three groups with a 1:1:1 ratio: experimental group (received the thermo-sensitive sol–gel agent), control group (untreated), and comparator group (received 4% icodextrin). Patients were followed for 4 weeks postoperatively, and efficacy was evaluated by performing the visceral slide test to identify adhesion formation. In total, 183 patients were enrolled in the study, and 178 (97.3%) completed the trial. The incidence rate of abdominal adhesion formation was significantly lower in the experimental group than in the control group (7.9% vs. 21.1%, p = 0.040); however, it was similar between the experimental and comparator groups (7.9% vs. 13.8%. p = 0.299). At 4 weeks, no differences in adhesion-related symptoms were observed between the experimental and control groups. Adverse events were mostly mild and did not differ significantly among the three groups (p = 0.375). In conclusion, use of a thermo-sensitive sol–gel agent was safe and effective to prevent abdominal adhesions after benign gynecologic surgeries.
Details
- Language :
- English
- ISSN :
- 20770383
- Volume :
- 9
- Issue :
- 7
- Database :
- Directory of Open Access Journals
- Journal :
- Journal of Clinical Medicine
- Publication Type :
- Academic Journal
- Accession number :
- edsdoj.b96d247c3d13474e84fff1be76d2205f
- Document Type :
- article
- Full Text :
- https://doi.org/10.3390/jcm9072261