The Efficacy and Safety Study of a New Cross-linked Hyaluronan Hydrogel in the Reduction of Postsurgical Peritoneal Adhesions
BAP
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
1 other identifier
interventional
216
1 country
7
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2011
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 13, 2014
CompletedFirst Posted
Study publicly available on registry
June 18, 2014
CompletedJune 18, 2014
June 1, 2014
1.8 years
June 13, 2014
June 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The adhesion incidence under moderate/severe category
The patient percentage with modified American Fertility Society (mAFS) score (ovaries and tubes) more than 4 points.
9 weeks following primary laparoscopic gynecological surgery
Secondary Outcomes (8)
modified American Fertility Society (mAFS) score
9 weeks following primary laparoscopic gynecological surgery
Adhesion extent
9 weeks following primary laparoscopic gynecological surgery
Adhesion severity
9 weeks following primary laparoscopic gynecological surgery
The adhesion incidence under moderate/severe category
9 weeks following primary laparoscopic gynecological surgery
modified American Fertility Society (mAFS) score
9 weeks following primary laparoscopic gynecological surgery
- +3 more secondary outcomes
Study Arms (2)
Control Arm
PLACEBO COMPARATORStandard of care for post-operative adhesion prevention included irrigation of tissues and lavage of all fluids with saline placebo following surgery
Cross-linked Hyaluronan Hydrogel Arm
EXPERIMENTALHyaRegen
Interventions
On the day of the initial surgery
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Beijing Chao-Yang Hospital
Beijing, Beijing Municipality, 100020, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Beijing Hospital
Beijing, Beijing Municipality, 100730, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
The Third Xiangya Hospital
Changsha, Hunan, 410013, China
Qilu Hospital
Jinan, Shandong, 250012, China
Related Publications (1)
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.
PMID: 25906706DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhenyu Zhang, MD, PhD
Beijing Chao Yang Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2014
First Posted
June 18, 2014
Study Start
June 1, 2011
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
June 18, 2014
Record last verified: 2014-06