A Trial Protocol to Investigate the Incidence of Postoperative Bowel Obstruction after Laparoscopic Colorectal Cancer Surgery Using an Absorbable Adhesion Barrier Material (INTERCEED^®) (Balsam CEED Study): A Prospective, Multicenter, Observational Study

Abstract

Background: Some studies have reported that adhesion prevention barriers (APBs) reduce adhesion after abdominal surgery; however, evidence showing that APBs reduce the incidence of postoperative small bowel obstruction (SBO), one of the most serious complications after abdominal surgery, is little. One concern is that APBs are usually applied only under the midline incision, although adhesion can occur at any place in the peritoneum where an incision is made during surgery. INTERCEED Ⓡ is an APB that reportedly prevents postoperative SBO after surgery. This study aims to assess the clinical utility of INTERCEED Ⓡ for the prevention of SBO after laparoscopic colorectal cancer surgery and determine whether the application site of INTERCEED Ⓡ affects the incidence of SBO. Methods/Design: This study is a prospective, multicenter, observational study conducted in Japan. The primary end point is the incidence of postoperative SBO 2 years after laparoscopic colorectal cancer surgery. The secondary end points include whether the site of the application of INTERCEED Ⓡ affects the incidence of SBO. Each surgeon selects one of the following three procedures: 1) INTERCEED Ⓡ is placed only under the midline incision; 2) INTERCEED Ⓡ is placed at the site of bowel mobilization and/or lymph node dissection, but not under the midline incision; and 3) INTERCEED Ⓡ is placed at both sites. Discussion: This is the first study to assess whether the placement of APBs affects the incidence of SBO. The study results may lead to a subsequent randomized study.

Clinical impact of laparoscopic surgery and adhesion prevention material for prevention of small bowel obstruction

“…Considering the effect of APMs in terms of reduction of adhesions, proper application of APMs, eg, a patch applied not only just under the incision, but also over the surgical dissection layer including sites of lymph node dissection, can be extremely important. We have started a prospective study to test this hypothesis 33 …”

“…We have started a prospective study to test this hypothesis. 33 This study has several limitations. First, because it was a retrospective study some patients had to be excluded for insufficient data.…”