POCERMust knowCD · Surgery
Crohn's disease management after intestinal resection: a randomised trial
De Cruz P, et al.
Lancet 2015 · PMID 25542620 (PubMed, opens in a new tab) · doi 10.1016/S0140-6736(14)61908-5 (full paper, opens in a new tab)
| Endpoint | Active care | Standard care | Difference |
|---|---|---|---|
| Endoscopic recurrence, Rutgeerts ≥i2 at 18 months · lower is better (primary endpoint) | 49% (60/122) | 67% (35/52) | P=0.03 |
| Complete mucosal normality, 18 months | 22% (27/122) | 8% (4/52) | P=0.03 |
Even with active care, about half had recurrence by 18 months, so monitoring continues after the first colonoscopy.
Source: De Cruz 2015, abstract (central reading blind to group).
Structured abstract
BackgroundMost patients with Crohn's disease need a resection, and many have recurrence afterwards. Whether to give drug prophylaxis alone or to monitor endoscopically and escalate was unknown.
MethodsRandomised trial (17 centres, Australia and New Zealand), 2:1 allocation, central endoscopy reading blinded to group. 174 patients. Primary endpoint: Endoscopic recurrence (Rutgeerts score ≥i2) at 18 months.
ResultsPrimary result. 49% (60/122) with active care vs 67% (35/52) with standard care; P=0.03.
Take-homeAfter resection, treating by risk and scoping at 6 months with step-up for recurrence beats drug prophylaxis alone; this is why we do a postoperative colonoscopy.
| Patients | 174 |
|---|---|
| Population | Patients having resection of all macroscopic Crohn's disease with an endoscopically accessible anastomosis; 83% were high risk for recurrence. |
| Comparison | Colonoscopy at 6 months with step-up for recurrence (active care) vs no 6-month colonoscopy (standard care) |
| Drugs | metronidazole, thiopurine, adalimumab |
| Classes | Antibiotic, Thiopurine, Anti-TNF |
| Published | De Cruz P, et al. Lancet 2015;385:1406–17. |
Key points
- All patients received 3 months of metronidazole; high-risk patients also received a thiopurine, or adalimumab if thiopurine-intolerant. Recurrence (Rutgeerts ≥i2) at 6 months triggered step-up to a thiopurine, fortnightly adalimumab plus thiopurine, or weekly adalimumab.
- Complete mucosal normality at 18 months: 22% (27/122) vs 8% (4/52); P=0.03.
- 39% (47/122) of the active-care group stepped up treatment at 6 months; 38% (18/47) of these were in remission 12 months later.
- Of those in remission at 6 months who did not change therapy, 41% (31/75) had recurrence by 18 months, so monitoring must continue.
- Smoking increased the risk of recurrence (OR 2.4, 95% CI 1.2–4.8; P=0.02).
- Adverse events (82% vs 87%) and serious adverse events (27% vs 35%) did not differ significantly.
Limitations
- Open-label to patients and physicians.
- Mostly high-risk patients; the strategy used thiopurines and adalimumab only.
- Some patients with recurrence at 6 months were not rescued by step-up, and early remission did not prevent later recurrence.
Commentary
POCER is the basis of the standard postoperative pathway in Crohn’s disease: stratify risk at surgery (for example smoking, penetrating disease, previous resection), start prophylaxis in high-risk patients, and perform ileocolonoscopy 6 to 12 months after surgery, escalating therapy for Rutgeerts i2 or worse.
Drug trials in the postoperative setting include PREVENT (infliximab) and REPREVIO (vedolizumab). Intestinal ultrasound and calprotectin are increasingly used between colonoscopies.
Journal club
Design
Randomised trial (17 centres, Australia and New Zealand), 2:1 allocation, central endoscopy reading blinded to group. 174 patients.
Primary result. 49% (60/122) with active care vs 67% (35/52) with standard care; P=0.03.
Validity and applicability
- Open-label to patients and physicians.
- Mostly high-risk patients; the strategy used thiopurines and adalimumab only.
- Some patients with recurrence at 6 months were not rescued by step-up, and early remission did not prevent later recurrence.
Where it sits now
After resection, treating by risk and scoping at 6 months with step-up for recurrence beats drug prophylaxis alone; this is why we do a postoperative colonoscopy.
- PREVENT (2016): In patients at increased risk, postoperative infliximab roughly halves endoscopic recurrence but did not significantly reduce clinical recurrence by week 76, so endoscopic monitoring is still needed.
- REPREVIO (2025): Starting vedolizumab within 4 weeks of ileocolonic resection reduces early endoscopic recurrence in patients at risk.
- SPICY (2024): Removing more mesentery at primary ileocolic resection did not reduce 6-month endoscopic recurrence, and leaks were numerically more common.
- LIR!C (2017): For limited (40 cm or less), non-stricturing terminal ileal Crohn's disease that has failed conventional therapy, laparoscopic resection is a reasonable alternative to starting an anti-TNF.
Questions for discussion
- Patients and physicians knew the allocation, but endoscopy was read centrally and blind to group. Which biases remain?
- How would you combine POCER's strategy with newer postoperative options such as infliximab (PREVENT) or vedolizumab (REPREVIO)?
- Some patients in remission at 6 months later had recurrence. How would you schedule monitoring after the first postoperative colonoscopy?