Assessment of the Manageability and Safety of ADBLOCK Adhesion Barrier System in Laparoscopic Gynaecological Surgery

Inclusion Criteria: * Female * 18-45 years * Indication for laparoscopic myomectomy according to the medical standard * Negative pregnancy test before study entry * Using adequate forms of contraception for 12 weeks following surgery (e.g. oral contraceptive pill, condom, no sexual intercourse) * In good health including an ASA (American Society of Anesthesiologists) score of 2 or less * No clinically significant and relevant abnormalities as evaluated by satisfactory medical assessment * Planned de novo removal of myoma (includes mural and combination of mural and pedunculated myoma) * Willing, able and likely to fully comply with study procedures and restrictions * Given written, personally signed and dated informed consent to participate in the study as approved by the Institutional Review Board/Ethics Committee of the respective Clinical Study Site. Exclusion Criteria: * Pre-Operative Exclusion Criteria: * Women who have completed their family planning * Current pregnancy including ectopic pregnancy * Breastfeeding * 6 weeks post-partum * Participation in another clinical study currently or within the last 30 days prior to enrolment * SGOT, SGPT and/or bilirubin \> 20% above the upper range of normal and considered clinically significant * BUN and creatinine \> 30% above the upper range of normal and considered clinically significant * Concurrent use of systemic corticosteroids, antineoplastic agents and/or radiation * Previous radiation therapy * Diabetes * Clinically relevant haemochromatosis, hepatic, renal, autoimmune, lymphatic, haematological or coagulation disorders * Active pelvic or abdominal infection, or other infection with fever (\>38°C) * Extensive keloid scarring * Known allergy to starch-based polymers * Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of the stated ingredients -Additional surgical procedure non-obstetrics and gynaecology (non- OB/GYN) planned to be performed during the laparoscopic procedure -\>4 myoma larger than 2 cms on preoperative ultrasound screen * Largest myoma \< 2 cms or \> 8 cms diameter on pre-operative screen -GNRH agonist/antagonist treatment (except oral contraceptive - combined oestrogen/progesterone) in the 4 weeks prior to study * Prior surgery for myoma * Previous bowl surgery, excluding appendectomy * Prior intra-abdominopelvic adhesive complications Intraoperative Exclusion Criteria * Clinical evidence of cancer * Clinical evidence of pregnancy including ectopic pregnancy * Clinical evidence of rectovaginal endometriosis * Clinical evidence of endometriosis American Fertility Society (AFS) class III or IV * Use, during this procedure, of any approved or unapproved product or strategy for the purpose of preventing adhesion formation including use of O2 enhanced insufflation * If the procedure needs to be performed by a laparotomy (decision made after laparoscopy has commenced) the patient must be withdrawn * Any unplanned surgery which involves opening of the bowel or urinary tract * Where hysteroscopy is required and it cannot be delayed until after removal of fibroid * Only pedunculated fibroids * Extensive pelvic adhesions (AFS severe adhesion score) or frozen pelvis * Adhesions that would require lysing during planned myomectomy surgery Other than inconsequential filmy adhesions that do not require specific lysing to access operative site * If pneumoperitoneum exceeds 90 minutes duration the patient will be assessed as a separate surgical covariate group for secondary endpoints only * Use of fibrin glue * Detection of myoma which are not suitable for surgery during the study procedure