- Design
- Multicentre randomised trial, open label with blinded endpoint assessment
- Population
- 118 adults after open rectal cancer resection with planned ileostomy closure
- Primary outcome
- Adhesions under the incision at second surgery
- Effect
- 45% (26/58) vs 93% (56/60); P < .001
A multicentre randomised trial in JAMA Surgery (1 October) enrolled patients having open rectal resection for cancer at 53 Japanese hospitals, all with a planned later ileostomy closure. Before abdominal closure, the intervention group received 2 to 3 g of a cross-linked, powdered chondroitin sulfate barrier sprayed into the abdomen and pelvis; controls received nothing. Adhesions were assessed at the second operation by blinded central reviewers.
In the 118 patients who had the second operation, adhesions under the incision were found in 45% (26 of 58) with the barrier versus 93% (56 of 60) without it. Adhesion severity and extent were also lower, and no safety concerns were identified.
This is a pivotal device trial with an anatomical endpoint, not one of bowel obstruction or reoperation, and the product is not yet widely available. It is worth knowing about for units planning staged procedures, but there is no outcome evidence yet to change routine closure.
- Note that adhesion barriers have not yet been shown to reduce bowel obstruction or reoperation in this trial.
- Consider adhesion burden when planning staged procedures such as later stoma reversal.
- Check local availability and regulatory status before considering this barrier outside a trial.
- Continue standard measures that limit adhesions, such as gentle tissue handling and minimally invasive access where suitable.
Why it matters
A spray-on barrier that coats uneven pelvic surfaces could make second operations easier, if clinical outcomes follow.
Don't overread it
The endpoint was adhesions seen at reoperation, not obstruction, pain or operative time.
The statistics, in plain English
45% versus 93% is an absolute reduction of about 48 percentage points in adhesions under the incision. The trial was open-label for surgeons but used blinded assessors, which limits bias in judging adhesions.
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