Assess the feasibility of CollaGUARD following Hysteroscopic Adhesiolysis.
Intrauterine adhesions following gynaecological surgery is a major complication which may cause a range of severe clinical symptoms in women. IUA's can result in menstrual abnormalities, dysmenorrhea and infertility. In pregnancy, adhesions are related to miscarriage, ectopic pregnancy, abnormal placentation, premature labor and delivery and possibly birth defects. CollaGUARD adhesion barrier is a transparent bioresorbable film approved in Europe for the prevention of postoperative adhesions in patients undergoing abdomino-pelvic laparotomy or laparoscopy. This study will assess the feasibility of using CollaGUARD adhesion device in hysteroscopic surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Sint Lucas Andreas Ziekenhuis
Amsterdam, Netherlands
Spaarne Ziekenhuis
Hoofddorp, Netherlands
Feasibility of using CollaGUARD in hysteroscopic adhesiolysis: Surgeon completed questionnaire
surgeon completed questionnaire
Time frame: following initial hysteroscopy
Number of de novo adhesion and adhesion reformation
assessed during follow-up hysteroscopy
Time frame: 9 weeks post initial hysteroscopy
Change in severity of adhesions
European Society Gynecological Endoscopy (ESGE) classification of IUA's; modified American Fertility Society (mAFS)
Time frame: 9 weeks post initial hysteroscopy
Degradation of CollaGUARD
assessed via ultrasound
Time frame: 2 weeks post initial hysteroscopy
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