Adhesions, Endometriotic Cysts, Myomas, Ovary Cysts
Conditions
Keywords
Adhesions, Hyaluronan, Gynaecological surgery, Clinical outcomes
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.
Interventions
OTHERSaline
On the day of initial surgery
DEVICECross-linked Hyaluronan Hydrogel
On the day of the initial surgery
Sponsors
BioRegen Biomedical (CHangzhou) Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The adhesion incidence under moderate/severe category | 9 weeks following primary laparoscopic gynecological surgery | The patient percentage with modified American Fertility Society (mAFS) score (ovaries and tubes) more than 4 points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| modified American Fertility Society (mAFS) score | 9 weeks following primary laparoscopic gynecological surgery | modified American Fertility Society (mAFS) score of ovaries/tubes |
| Adhesion extent | 9 weeks following primary laparoscopic gynecological surgery | Adhesion extent of ovaries/tubes |
| Adhesion severity | 9 weeks following primary laparoscopic gynecological surgery | Adhesion severity of ovaries/tubes |
| The adhesion incidence under moderate/severe category | 9 weeks following primary laparoscopic gynecological surgery | The patient percentage with modified American Fertility Society (mAFS) score (throughout abdominopelvic cavity) more than 4 points. |
| Adverse events | Up to 9 weeks | Safety evaluation was based on clinical laboratory tests, the type and severity of adverse events recorded throughout the study, etc. |
Countries
China
Outcome results
None listed