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