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
Condition: Tissue Adhesions
MeSH terms: Tissue Adhesions
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to obtain data on the safety and manageability of applying LABS™
      to the uterus and other areas of surgical trauma in the pelvis and abdomen following
      laparoscopic gynaecologic surgery. In addition, performance data following a clinical
      indicated second look laparoscopy will be collected for the purpose of determining sample
      size predictions for future trials.
    

Detailed description: 
      Women undergoing laparoscopic uterine myomectomy, adhesiolysis, treatment of endometriosis or
      ovarian cystectomy with associated adhesions and/or endometriosis, and planned, clinically
      indicated second look laparoscopy within 4-12 weeks will be enrolled into one of two sub
      studies in which the major component of the surgery (as determined by the surgeon) was due
      to:

        1. Myomectomy Or

        2. Other Gynaecology Pathology (repeat myomectomy, adhesiolysis, and/or treatment of
           endometriosis, ovarian cystectomy with associated adhesions or endometriotic pathology,
           removal of adenomyoma without myomectomy.

      The myomectomy sub study will include two arms:

        1. Pure Myomectomy -myomectomy with no endometriosis and no adhesions/few filmy uterine
           adhesions - blunt dissection only

        2. Hybrid Myomectomy - myomectomy with (+/-) adhesions and/or (+/-) endometriosis and/or
           (+/-) adenomyomectomy Patients in each sub study (1 or 2) and each arm of the myomectomy
           study (a or b) will be randomized to receive LABS™ following their laparoscopic surgery
           or current standard of care: surgery only control. All patients will be blinded to their
           treatment status until study completion.

      Sub study and sub-group allocation as well as randomisation will occur once the initial
      laparoscopy is completed but before removal of the laparoscope. Myomectomy patients
      randomized to receive LABS™ will then have the device sprayed to the entire surface of the
      uterus and other areas of surgical trauma. In all treated patients all sites of surgical
      trauma should be completely covered with LABS™ allowing a sprayed margin of at least 3 cm
      around the operated or traumatised site.

      Patients receiving LABS™ will be compared to patients who have had the current standard of
      care: surgery alone. In addition to an overall comparison, they will be compared to patients
      in the same sub study (1 or 2) and same arm of the myomectomy study (1a or 1b).

      The first two patients entered by each operating surgeon will be allocated to LABS™ and
      assessed for the application of LABS™. They will not be counted as fully evaluable randomized
      patients. These patients will be sequentially assigned and evaluated. With confirmatory
      evaluation of and application of LABS™ on the first patient, the surgeon will be advised to
      assign the second. With the same confirmatory evaluation on the second patient and both
      patients discharged from hospital the surgeon will be permitted to proceed with the study and
      randomise patients.

      Both the initial laparoscopic procedure and the clinically indicated second look laparoscopy
      will be video recorded to allow for a blinded evaluation of LABS™ application and a separate
      blinded evaluation of adhesions and other pathology in all patients - treated and controls.
      This evaluation will be cross checked with the operating surgeon's own evaluations and
      reconciled according to a specified protocol.

      Where, during initial surgery, a second look laparoscopy is no longer considered clinically
      indicated but the surgeon randomizes the patient, they will be followed for safety
      evaluations only.
    

Intervention name(s): LABS™; Surgical Control
Intervention type(s): Device; Procedure
Intervention description(s): hydrogel sprayed laparoscopically over all pelvic areas of surgical trauma; Surgery only
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention