New Cross Linked Hyaluronan Gel After Deep Infiltrating Endometriosis Surgery

• Status: Completed
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Treatments: Hyaluronic Acid

Criteria

Inclusion Criteria:

• aged 18 to 45 years

• undergoing laparoscopic surgery for suspicious of DIE

• persistent pain irrespective to any medical treatment

Exclusion Criteria:

• acute or severe infection

• autoimmune disease

• known/suspected intolerance or hypersensitivity to hyaluronan or its derivatives

• concurrent use of a systemic anti-inflammatory or hormonal drug at least 3 months prior to the surgery

• clinical evidence of cancer

• use of anticoagulant, fibrin glue, other thromboembolic agents

• use of any other anti-adhesion agent during the procedure

• patients with surgically diagnosed bowel involvement or need bowel resection

• patients who want to receive any postoperative hormonal treatment