Background

Adhesive small intestine occlusion [ASIO] is an important cause of hospital admission placing a substantial burden on healthcare systems worldwide. Often times, ASIO is associated with significant morbidity and mortality.

Icodextrin 4% solution [Adept, Shire Pharmaceuticals, UK] is a high-molecular-weight a-1,4 glucose polymer that is approved in Europe for use as an intra-operative lavage and a post-operative instillate to reduce the occurrence of post-surgery intra-abdominal adhesions.

There are no randomized trials on the use of this solution to prevent adhesions after ASIO operation in current medical literature.

The current clinical study evaluates the safety and effectiveness of Icodextrin 4% for decreasing the incidence, extent, and severity of adhesions in patients after abdominal surgery for ASIO.

Design

The study project is a prospective, randomized controlled investigation performed in the Department of Transplant, General and Emergency Surgery of St. Orsola-Malpighi University Hospital [Bologna, Italy]. The study is designed and conducted in compliance with the principles of Good Clinical Practice regulations.

The study compares the results of Icodextrin 4% against a control group who does not receive anti-adhesion treatment. This randomized study uses a double-blind procedure to evaluate efficacy end points. In other words, designated third party individuals who are unaware of the treatment assigned to the patients to assess adhesion formation.

Trial Registration Number

ISRCTN22061989

Prospective controlled randomized trial on Prevention of Postoperative Abdominal Adhesions by Icodextrin 4% solution after laparotomic operation for small bowel obstruction caused by adherences

[POPA study: Prevention of Postoperative Adhesions]