Abstract
Background/Objectives: Surgical removal of deep endometriosis lesions is an established method of reducing patient symptoms, but it often results in iatrogenic adhesions that lead to further problems. This pilot study presents the safety evaluation of a novel self-cross-linked hyaluronic acid gel used to reduce adhesions after non-bowel deep endometriosis surgery. Methods: A single cohort, single-center, non-randomized pilot study was conducted in patients diagnosed with non-bowel deep endometriosis who underwent a three-stage treatment regimen consisting of first surgery, hormone therapy and second surgery. The present report is limited to an analysis of the inflammatory parameters, pain and complications occurring within a 72 h period following the initial laparoscopy (FLL) utilizing the anti-adhesion gel. Results: 60 patients (28.48 ± 5.9 years old) were included. 24 h after the intervention, a slight elevation in C-reactive protein levels was observed in 38.33% of cases (0.98 ± 1.46 mg/dL), with a statistically significant difference after FLL (0.98 ± 1.46 mg/dL before FLL vs. 1.03 ± 1.29 mg/dL after FLL; p =< 0.001); there were no patients with levels above 10 mg/dL before or after surgery. 24 h after FLL, 29.33% of patients had a leukocyte count greater than 11 Thous/μL, with a maximum observed value of 16.2 Thous/μL. The count was found to be statistically significantly higher after FLL (6.03 ± 1.91 Thous/μL before FLL vs. 9.15 ± 2.61 Thous/μL after FLL; p =< 0.001). At 72 h post-intervention, postoperative pain was reported in up to 63.33% of cases, and one urinary tract infection with fever occurred but was not considered to be related to the product. No serious adverse events were observed. Conclusions: The results of this exploratory study showed a safe range of inflammatory response within a 24 h period following the application of the novel self-cross-linked hyaluronic acid antiadhesion gel (HyaRegen(®)) in patients who underwent laparoscopic surgery for non-bowel deep endometriosis.