drugset / Trial / NCT04023383

New Cross Linked Hyaluronan Gel After Deep Infiltrating Endometriosis Surgery

NCT04023383 ↗

RandomizedParallel-groupDouble-blindSupportive care

Summary

Hyaluronan, a glycosaminoglycan found in connective tissues and extracellular matrix, has been postulated to reduce postoperative adhesions, because of its unconditioned biological functions at tissue repair but unfortunately it has a fluid nature that causes rapid degradation, and it cannot effect long enough to work as an adhesion barrier.(10,11) For this reason a New cross-linked hyaluronan (NCH) gel, that has higher viscosity compared to natural hyaluronan has been developed by BioRegen Biomedical (Changzhou, Jiangsu, China). It has the ability for gradually absorption within 1 to 2 weeks in vivo, which are the acquired repair period and the critical time for adhesion formation. Although it seems evident that endometriosis has a serious impact on the daily Quality of Life of women; comparable data for the effect of adhesion barriers to patients who have had laparoscopic (Deep infiltrating endometriosis) DIE surgery is missing. Therefore a pilot randomised controlled study was conducted to evaluate the effect of NCH gel on short term quality of life in patients who had undergone laparoscopic surgery due to DIE.

Timeline

Start
2017-01-01
Primary completion
2019-01-01
Completion
2019-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject HyaRegen NCH Other / unclassified 40 ml Other

Indications