Short Course Endocavitational Vacuum Therapy for Ileal Pouch Leaks
Research type
Research Study
Full title
Short Course Endo-Cavitational Vacuum Therapy to Facilitate Sepsis Control and Early Closure in Ileal Pouch Anastomotic Leaks
IRAS ID
208746
Contact name
Omar Faiz
Contact email
Sponsor organisation
London North West Healthcare NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
For patients who require removal of the entire large bowel and rectum, an ileoanal pouch allows them to live without a permanent stoma (bag) and pass bowel content in the normal fashion. To make a pouch the last part of small bowel is folded back on itself to form a reservoir which functions like the rectum that was removed, this pouch is then joined to the anus. As with any surgical procedure, pouch surgery is not without complications. A leak from the join between the pouch and anus is a major cause of pouch failure, which means a permanent stoma.
Historically, leaks were managed by radiologically or surgically guided drainage. Both have their disadvantages. More recently, vacuum therapy has been used to manage pouch leaks with encouraging results. This technique has the advantage over traditional drainage because the infection is suctioned away, rather than relying on gravity or pressure to drain infected fluid. As the cavity is drained, the suction encourages it to collapse in on itself, thereby closing the space and decreasing the likelihood of an abscess re-forming.
Since 2014 a novel method of using vacuum therapy has been trialled. Rather than changing the vacuum sponge regularly over the course of several months, gradually reducing the size over time, the new method relies on only a small number of changes to clean the cavity and encourage healing before the leaking join is surgically closed. This should reduce the pouch inflammation and reduce the chance of failure. The results so far have been promising.
This study aims to establish the safety, feasibility and effectiveness of short-course vacuum therapy to allow early closure of ileoanal pouch defects in patients with pouch leaks.
REC name
London - Brent Research Ethics Committee
REC reference
18/LO/1189
Date of REC Opinion
9 Oct 2018
REC opinion
Further Information Favourable Opinion