Crohn’s Extent of Resection Trial (CERT) v1.04

  • Research type

    Research Study

  • Full title

    Crohn’s Extent of Resection Trial (CERT): A randomised controlled trial comparing anastomotic disease recurrence following 2cm versus 10cm resection margins for patients with ileocolic Crohn’s disease

  • IRAS ID

    113518

  • Contact name

    Richard E Lovegrove

  • Contact email

    r.lovegrove@me.com

  • Research summary

    Crohn’s disease is a chronic inflammatory bowel condition. Up to 80% of patients will require abdominal surgery during their lifetime. Unfortunately, recurrence of Crohn’s disease is common after surgical resection, with more than 50% having clinical recurrence within 5 years. Endoscopic recurrence at the surgical join may be detected in 70-80% of patients 6 months post surgery.

    The question of the extent of surgical resection has been addressed previously. Many studies showed that microscopic inflammation at the resection margins is not predictive of subsequent recurrence. However, one study found that inflammation around nerves (plexitis) at the resection margin was a risk factor for endoscopic recurrence.

    The conventional surgical principle is to resect the minimum length of bowel consistent with obtaining healthy margins for anastomosis. The landmark study by Fazio et al (1996) showed no difference in surgical recurrence between a margin of 2cm compared to a margin of 12cm. Their results however showed a trend towards lower surgical recurrence in those with a 12cm margin, however, this study may have been too small to demonstrate a significant difference.

    The aim of this study is to compare the conventional minimal resection margin (2cm) with a modest resection margin (10cm). Eligible patients would be randomised intra-operatively to one of the above groups. Surveillance colonoscopy at 6 months postoperatively, which is routine practice, would be used to assess disease recurrence at the surgical join. Patients would be followed up as per routine clinical practice thereafter.

  • REC name

    South Central - Berkshire B Research Ethics Committee

  • REC reference

    13/SC/0235

  • Date of REC Opinion

    5 Jul 2013

  • REC opinion

    Further Information Favourable Opinion