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

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