Case Study: Phase lllB/lV #1
The primary objectives of this study were to assess:
• A comparative study looking at the impact and potential efficacy of an intra-operative washing solution with a 1 litre post-operative instillate in the reduction of post-operative de novo adhesion formation within the abdominal cavity following 'virgin' laparoscopic surgery for fibroids or endometriotic cysts.
• The potential impact of --- in reducing the extent and severity of de novo adhesion formation within the abdominal cavity following 'virgin' laparoscopic surgery for fibroids or endometriotic cysts, compared with lactated Ringer's solution (LRS).
The secondary objectives of this study were to assess the potential impact in reducing reformation of any pre-existing and lysed adhesions (around the ovarian fossa) following 'virgin' laparoscopic gynaecological surgery on patients with endometriotic cysts.
Allow the investigator sites (key prescribers) to have hands-on experience in 330 patients in 29 sites in Belgium, France, Germany, Greece, Italy and UK.
• Capturing the video images was the big challenge (technical and logistical).
• Client's request to work with a third party vendor to select sites.
• The video technology initially proved difficult for the investigators to use but was quickly addressed by provision of additional training to achieve data gathering targets.
• Clear allocation of roles and responsibilities with a client specified third party vendor who selected the sites and were involved in the CRO selection process.
Resourcing well managed by allocation of appropriately experienced key team members at start up. Start-up of projects crucial to overall success so even though study looks simple and straightforward, assigning higher level key team members was justified in building credibility with this new client.