A Randomized Multi-centre Study to Assess the Safety and Manageability of a Laparoscopic Adhesion Barrier in Women Undergoing Gynecologic Laparoscopic Surgery Followed by Second Look Laparoscopy

PREOPERATIVE INCLUSION

Preoperatively the patient must:

• understand and be able to follow the requirements of the protocol including signing and dating an Ethics Committee approved Informed Consent prior to undergoing any protocol related procedures
• be a premenopausal female who is > 18 and < 46 years old
• be thought to have gynaecologic pathology requiring laparoscopic surgery - including uterine fibroids (including those with only anterior fibroid or repeat myomectomy/previous uterine artery embolization for fibroid), adhesions, and/or endometriosis with or without associated pathology such as ovarian cysts
• wish to retain her fertility
• and thus be considered to clinically benefit from a second-look laparoscopic procedure;
• have a willingness to undergo a second-look surgical procedure if clinically indicated
• have a negative pregnancy test within 5 days of surgery
• agree to avoid pregnancy using adequate forms of contraception through the time of performance of second-look laparoscopy (oral contraceptive pill, condom, no sexual intercourse), and if the patient is undergoing myomectomy that she is aware that it is good advice to avoid pregnancy for a 12 week period to allow healing of the uterine scar before becoming pregnant
• be in good health including an ASA (American Society of Anaesthesiologists) score of 2 or less
• following physical and medical assessment have no clinically significant or relevant abnormalities.

PREOPERATIVE EXCLUSION

Preoperatively a patient must not:

• be unable to give their own written informed consent,
• have completed her family planning with no desire to maintain fertility,
• be considered to have no potential clinical benefit from a second look laparoscopy,
• be breastfeeding,
• be within 6 weeks post-partum
• have received or is expected to receive another anti-adhesive treatment within 30 days prior to enrolment or during enrolment up to adhesion evaluation at second look laparoscopy,
• be currently enrolled in another clinical study or has been in another study within the last 30 days,
• have received or is expected to receive any other investigational product or technique within 30 days prior to or during enrolment,
• have had cancer within 5 years of the initial surgery with the exception of basal cell carcinoma,
• have known allergy to dextran, PEG, or FD\&C Blue #1,
• be scheduled to undergo concomitant non-gynaecological surgery,
• be currently pregnant (including ectopic pregnancy),
• have received GNRH agonist/antagonist, Depo Provera, danocrine, ulipristal acetate or similar treatment (except oral contraceptives - and including progesterone only) in the 4 weeks prior to study,
• on pre-operative imaging have
• Largest fibroid < 2 cms
• Or largest fibroid > 10 cms diameter intramural
• Or more than 5 large fibroids (large = >8 cms diameter)
• And/or adenomyoma >10cm identified
• have a history where it is expected that complete adhesiolysis will not be possible,
• preoperatively have clinically significant abnormal blood results including:
• SGOT, SGPT and/or bilirubin > 20% above the upper range of normal and/or
• BUN and creatinine > 30% above the upper range of normal,
• have clinically relevant hemochromatosis, hepatic, renal, autoimmune, lymphatic, haematological or coagulation disorders,
• have insulin dependent diabetes mellitus,
• be receiving concurrent systemic corticosteroids, antineoplastic agents and/or radiation therapy,
• have had previous radiation therapy,
• have active pelvic or abdominal infection, or other active infection with fever >38°C.

INTRAOPERATIVE INCLUSION

During surgery the patient must have:

• treatment of uterine fibroids, endometriosis, and or adhesions, with or without associated pathology such as ovarian cysts, and meets all intraoperative inclusion/exclusion criteria prior to randomisation, including that a SLL is clinically indicated

Additionally for the myomectomy sub study, during surgery it must be confirmed that:

• the patient underwent a laparoscopic myomectomy with at least (1) posterior uterine serosal incision of > 3 cm in length
• that the major portion of the procedure (in the opinion of the surgeon) was related to myomectomy
• that the patient meets all intraoperative inclusion/exclusion criteria prior to randomisation. and
• at the completion of the procedure, prior to randomisation, the surgeon continues to believe that the patient will clinically benefit from second- look laparoscopy.

INTRAOPERATIVE EXCLUSION

Intraoperatively a patient must not:

• have cancer detected at surgery,
• be pregnant, including ectopic pregnancy,
• have a non-gynaecological surgical procedure or entry into the bowel, bladder, or ureter,
• have a hysterectomy or other gynaecological procedure that would render the patient unable to conceive
• receive the administration of a product that will interfere with the application of LABS™ Adhesion Barrier Material,
• receive the use of an approved or unapproved product or strategy for the purpose of preventing adhesion development,
• receive fibrin glue, surgical sealant, or other haemostatic agent,
• undergo an open procedure
• undergo a posterior colpotomy,
• undergo insufflation with a gas other than CO2,
• undergo Laprolift or similar device for elevation of the abdominal wall, as an alternative to CO2 insufflation,
• undergo abdominal cavity humidification or oxygenation,
• undergo robotic surgery,
• receive irrigants containing, glucocorticoids, antihistamines, heparin or antiseptic additives.
• have a postoperative drain
• does not have complete lysis of any adhesions to the posterior uterus
• has deep infiltrating endometriosis that is not treated during surgery
• patient had ovarian cysts with no other pathology
• be considered to have no clinical indication for a SLL

For the myomectomy sub study the patient:

• does not undergo laparoscopic myomectomy with at least (1) posterior uterine serosal incision of > 3 cm in length,
• has only pedunculated fibroids removed from the posterior aspect of the uterus
• has adenomyoma alone without fibroids
• has therapeutic hysteroscopy with treatment of congenital malformation, myomectomy or treatment of Asherman's syndrome
• excepting diagnostic hysteroscopy or polypectomy with lactated Ringer's solution (LRS) undertaken prior to laparoscopy and all fluid removed prior to laparoscopic filming.