Status:
COMPLETED
New Cross Linked Hyaluronan Gel After Deep Infiltrating Endometriosis Surgery
Lead Sponsor:
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Conditions:
Endometriosis
Adhesion
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief 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...
Detailed Description
A prospective 1:1 randomised placebo-controlled study was conducted in our department during the study period January 2017-January 2019. All patients were included after obtaining written, signed info...
Eligibility Criteria
Inclusion
- aged 18 to 45 years
- undergoing laparoscopic surgery for suspicious of DIE
- persistent pain irrespective to any medical treatment
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04023383
Start Date
January 1 2017
End Date
June 1 2019
Last Update
March 15 2021
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