- Design
- Randomised controlled trial, 1:1, retrospectively registered
- Population
- 200 patients with stage II or III middle or lower third rectal cancer undergoing laparoscopic low anterior resection
- Primary outcome
- Stoma-free status through 12 months
- Effect
- Ileostomy 22.0% vs 100.0% (p < 0.001); leak 0% vs 1.0%; complications 31.0% vs 32.0%
Diverting ileostomy is routine after low anterior resection for rectal cancer even though few patients develop a true anastomotic leak. This randomised trial assigned 200 patients with stage II or III middle or lower third rectal cancer, all undergoing laparoscopic resection, to routine ileostomy or a selective strategy. In the selective arm CRP was measured daily from day 1, and a day 3 value of 114 mg/L or a rise of more than 15 mg/L a day triggered contrast CT. An ileostomy was formed only if the CT was suspicious for leak.
Ileostomy formation was 22.0% in the selective arm and 100% in the routine arm. Confirmed leakage was 0% versus 1.0% and overall complications were 31.0% versus 32.0%. Stoma-related complications were 3.0% versus 30.0%, and patient-reported global health and physical and emotional functioning scores were better in the selective arm.
Leaks were so rare in both arms that the trial cannot show the selective approach is as safe for leak consequences; it was also retrospectively registered, and the protocol includes daily CRP and ready CT access. It supports further study and local audit more than a switch away from routine diversion.
- Selective diversion used daily CRP from day 1, with CT triggered at CRP 114 mg/L on day 3 or a rise over 15 mg/L a day.
- Ileostomy was formed in 22% of the selective arm against all patients in the routine arm.
- Leak was 0% versus 1.0%, too few events to show equal safety.
- The approach assumes daily bloods, rapid CT and surgeons able to return to theatre for a stoma.
- Consider discussing it in your unit's rectal cancer meeting; do not adopt it on this trial alone.
Why it matters
It challenges the assumption that every low anastomosis needs a stoma to protect it.
Don't overread it
Retrospective trial registration and very few leaks mean the safety of omitting diversion is not established.
The statistics, in plain English
Zero leaks in one arm and one in the other means the study had almost no information on leak itself, so 'no difference' here means 'too few events to tell', not 'equally safe'. The large drop in stomas is a robust finding because the control arm was 100% by design.
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