None listed
Conditions
Brief summary
A randomised trial to determine whether using a sprayable adhesion barrier onto the operative field during removal of a gastric band will make a future laparoscopic sleeve gastrectomy quicker and safer due to reduced scar formation where the gastric band used to be.
Interventions
The intervention is performed at the end of the laparoscopic gastric band removal before removing all the laparoscopic ports. It is a Polymer Kit containing two precursor solutions, a polyethylene glycol (PEG) ester trilysine amine solution and a borate buffer solution. These are mixed together causing the precursors to link forming a synthetic, absorbable, hydrogel adhesion barrier. The reconstituted Polymer Kit syringes are attached to an applicator to allow the polymer to be sprayed onto the operative field. Upon spraying, the polymer liquids mix and rapidly cross-link to form a thin, flexible, tissue adherent, hydrogel adhesion barrier.
Sponsors
Study design
Eligibility
Inclusion criteria
Patients undergoing a staged conversion of a gastric band to a laparoscopic sleeve gastrectomy who meet the following criteria: 1 Any sex 2 Aged over 18 3 Proficient at speaking and understanding written English 4 Ability to understand the consent process
Exclusion criteria
1 Band erosion as reason for gastric band removal 2 Previous major surgery with suspicion of pre-existing adhesions 3 Pregnant or lactating 4 Renal or hepatic impairment 5 Known allergy to blue food colourings