The effect of new cross linked hyaluronan gel on quality of life of patients after deep infiltrating endometriosis surgery: a randomized controlled pilot study

Abstract

In this prospective randomised placebo-controlled study, we aimed to evaluate the effect of New Cross linked Hyaluronan Gel (NCH gel) on the quality of life of patients who underwent laparoscopic surgery due to Deep Infiltrating Endometriosis (DIE). The intervention group received 40 mL of NCH gel, and the control group had a 40 mL sterile saline solution instilled into the peritoneal cavity following standard laparoscopic procedures. The patients were called in the third and sixth postoperative months and requested to fill the Visual Analogue Scale (VAS), Endometriosis Health Profile (EHP-5), and Short Form for Mental and Physical Health (SF-12) questionnaires. There was a significant reduction in dysmenorrhoea, dyschezia, dyspareunia VAS scores at 3rd, and 6th-month visits in NCH gel group. The postoperative 6th-month EHP-5 scores were significantly lower (1.16 ± 1.51, p-value: .02) in NCH gel group. Besides, NCH gel group had higher SF-12 mental and SF-12 physical scores.

Clinical Trials registration number: NCT04023383

IMPACT STATEMENT

• What is already known on this subject? Application of solid or liquid physical barriers is believed to be a promising strategy to reduce adhesions after laparoscopic endometriosis surgery. However, comparable data regarding the effects of adhesion barriers are still lacking.

• What the results of this study add? We revealed that there was a significantly higher decrease in VAS and EHP-5 scores and an increase in SF-12 physical-mental ratings after surgery in NCH gel group.

• What are the implications of these findings for clinical practice and/or further research? Using NHC gel in addition to standard surgical procedure improves postoperative VAS scores, and provides better quality of life scores.

Keywords:

• Endometriosis
• hyaluronic acid
• quality of life
• tissue adhesions
• adhesion barriers

Disclosure statement

No potential conflict of interest was reported by the author(s).

Additional information

Funding

This study is supported partly (providing New Crosslinked Hyaluronan Gel) by grants from Bilar Medical, Istanbul, Turkey (Bioregen Medical Changzhou Co Ltd).