A Randomized Controlled Trial of Thermo-Sensitive Sol–Gel Anti-Adhesion Agent after Gynecologic Surgery

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.

Anti-adhesive effect and safety of a thermosensitive adhesion barrier (Mediclore) for thyroid surgery: a double-blinded randomized controlled trial

“…Similar to several previous studies, this study confirmed that Mediclore could be used safely [ 9 10 11 12 ]. Inflammatory assessment by questionnaire confirmed the absence of Mediclore-associated inflammatory response.…”

“…Mediclore acts as an external barrier to prevent adhesion until absorbed for approximately 20 days. Anti-adhesive and antibacterial effects of Mediclore have been reported in various studies [ 9 10 11 12 21 22 ].…”

“…Mediclore (CGBio Co., Ltd., Seongnam, Korea) is a thermosensitive sol-gel anti-adhesion solution mixed with a highly biocompatible and water-soluble polymer formulation capable of sol-gel transition. Mediclore exists as a sol (liquid) at room temperature; it becomes a high-viscosity gel when it reaches body temperature after application inside the human body, and it is expected to have an excellent anti-adhesive effect compared to conventional anti-adhesion agents [ 9 ]. Several studies have reported on the anti-adhesive effect of Mediclore for the following surgeries: (1) intranasal dacryocystectomy; (2) transurethral resection for benign prostatic hyperplasia; (3) rotator cuff repair; and (4) abdominal gynecological surgery [ 9 10 11 12 ].…”

“…Mediclore exists as a sol (liquid) at room temperature; it becomes a high-viscosity gel when it reaches body temperature after application inside the human body, and it is expected to have an excellent anti-adhesive effect compared to conventional anti-adhesion agents [ 9 ]. Several studies have reported on the anti-adhesive effect of Mediclore for the following surgeries: (1) intranasal dacryocystectomy; (2) transurethral resection for benign prostatic hyperplasia; (3) rotator cuff repair; and (4) abdominal gynecological surgery [ 9 10 11 12 ]. However, no studies analyzing the effect of Mediclore on thyroid surgery have not been conducted.…”

Thermosensitive Hydrogels and Advances in Their Application in Disease Therapy

“…In a randomized, controlled, single-blinded clinical trial conducted by Kim et al [93], the subjects were women who underwent benign gynecological surgery from January to December 2017. Patients were randomly divided (1:1:1) into a test group (received thermosensitive hydrogel treatment), control group (nontreatment), or a comparator group (received 4% icodextrin treatment), with four weeks of follow-up.…”