Clinical trial NCT02166554: The Efficacy and Safety Study of a New Cross-linked Hyaluronan Hydrogel in the Reduction of Postsurgical Peritoneal Adhesions
Official title: The Efficacy and Safety of a New Cross-linked Hyaluronan Hydrogel in the Reduction of Postsurgical Adhesions After Laparoscopic Gynecological Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Myomas
Ovary Cysts
Endometriotic Cysts
Adhesions
Keywords: Adhesions
Hyaluronan
Gynaecological surgery
Clinical outcomes
Lead sponsor: BioRegen Biomedical (CHangzhou) Co., Ltd
Sponsor class: INDUSTRY
First posted: 2014-06-18
Enrollment: 216
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The adhesion incidence under moderate/severe category
timeFrame: 9 weeks following primary laparoscopic gynecological surgery
Secondary outcomes:
measure: modified American Fertility Society (mAFS) score
timeFrame: 9 weeks following primary laparoscopic gynecological surgery
measure: Adhesion extent
timeFrame: 9 weeks following primary laparoscopic gynecological surgery
measure: Adhesion severity
timeFrame: 9 weeks following primary laparoscopic gynecological surgery
measure: The adhesion incidence under moderate/severe category
timeFrame: 9 weeks following primary laparoscopic gynecological surgery
measure: modified American Fertility Society (mAFS) score
timeFrame: 9 weeks following primary laparoscopic gynecological surgery
measure: Adhesion extent
timeFrame: 9 weeks following primary laparoscopic gynecological surgery
measure: Adhesion severity
timeFrame: 9 weeks following primary laparoscopic gynecological surgery
measure: Adverse events
timeFrame: Up to 9 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital
state: Beijing
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Changsha
country: China
facility: The Third Xiangya Hospital
state: Hunan
city: Jinan
country: China
facility: Qilu Hospital
state: Shandong
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Zhenyu Zhang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu C, Lu Q, Zhang Z, Xue M, Zhang Y, Zhang Y, Wang H, Li H, Zhou Y, Zhang Z, Li W; HyaRegen Adhesion Study Group. A Randomized Controlled Trial on the Efficacy and Safety of a New Crosslinked Hyaluronan Gel in Reducing Adhesions after Gynecologic Laparoscopic Surgeries. J Minim Invasive Gynecol. 2015 Jul-Aug;22(5):853-63. doi: 10.1016/j.jmig.2015.04.011. Epub 2015 Apr 20.