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.