The Efficacy and Safety Study of a New Cross-linked Hyaluronan Hydrogel in the Reduction of Postsurgical Peritoneal Adhesions

BioRegen Biomedical (CHangzhou) Co., Ltd216 enrolled

Overview

The purpose of this study was to determine whether the new crosslinked hyaluronan hydrogel was safe to use, and was effective for the prevention/reduction of adhesion formation following gynecological surgery

Postsurgical adhesions are a common medical complication of gynecologic and pelvic surgeries, and are frequently associated with chronic or recurrent pelvic pain, intestinal obstruction and infertility. This randomized, controlled, multicenter, clinical study was designed to evaluate the safety and performance of the new crosslinked hyaluronan hydrogel versus the standard of care for the reduction of postoperative adhesions in subjects undergoing laparoscopic surgeries. Subjects were scheduled to return at 9 weeks after the initial surgical procedure. At that time, a second-look laparoscopy was performed for postsurgical adhesion assessment. Adhesions were graded using a modified American Fertility Society (mAFS) scoring system.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

216

Conditions

Myomas Ovary Cysts Endometriotic Cysts Adhesions

Interventions

SalineOTHER

On the day of initial surgery

Cross-linked Hyaluronan HydrogelDEVICE

On the day of the initial surgery

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female. * Aged 18-45 years. * Been scheduled for removal of myomas, ovary cysts, endometriotic cysts or adhesions. * Been willing to comply with all aspects of the treatment and evaluation schedule. * Agreed to a second-look laparoscopic procedure to assess and lyse any adhesions formed at 9 weeks following the primary surgery. * Provided voluntary written informed consent. Exclusion Criteria: * Acute or severe infection. * Autoimmune diseases such as diabetes etc. * Abnormal liver/renal and cardiovascular function * Abnormal blood coagulation * Medical histories of peripheral vascular disease, alcohol or drug abuse, and mental illness. * Known or suspected intolerance or hypersensitivity to hyaluronan or its derivatives. * Concurrent use of systemic antiinflammatory drugs. * Clinical evidence of cancer. * Use of anticoagulant, fibrin glue, other thrombogenic agents, or any other anti-adhesion agent during the procedure. * Concurrent peritoneal grafting or tubal implantation.

Locations (7)

Beijing Chao-Yang Hospital

Beijing, Beijing Municipality, China

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Peking University First Hospital

Beijing, Beijing Municipality, China

Beijing Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

The adhesion incidence under moderate/severe category

The patient percentage with modified American Fertility Society (mAFS) score (ovaries and tubes) more than 4 points.