Mesenteric excision surgery or conservative limited resection in Crohn’s disease: study protocol for an international, multicenter, randomized controlled trial

Abstract

Background: The structures of the mesentery including adipose tissue, nerves, and lymphatics play an important role in the pathogenesis and disease progression of Crohn's disease (CD). Conventional surgical resection for CD usually does not involve resecting the mesentery en bloc with the specimen. This contrasts with complete mesocolic excision (CME) in colorectal cancer, which involves radical resection of the mesentery. Preliminary evidence from smaller studies suggests that applying the principle of mesocolic excision to CD surgery may reduce the risk of postoperative recurrence. This randomized controlled trial is designed to test whether applying the principles of mesocolic excision to CD results in reduced postoperative recurrence. It also aims to evaluate intra-and postoperative morbidity between the two approaches.Methods: This international, multicenter, randomized controlled trial will randomize patients (n = 116) scheduled to undergo primary ileocolic resection to either receive extensive mesenteric excision (EME) or conventional ileocolic resection with limited mesenteric excision (LME). Five sites will recruit patients in three countries. In the EME group, the mesentery is resected following CME, while avoiding the root region, i.e., 1 cm from the root of the ileocolic artery and vein. In the LME group, the mesentery is retained, i.e., "close shave" or < 3 cm from the border of bowel. The primary end point will be surgical recurrence after surgery. The secondary end points will be the postoperative endoscopic and clinical recurrence, and intra-and postoperative morbidity. Demographics, risk factors, laboratory investigations, endoscopy, postoperative prophylaxis and imaging examination will be assessed. Analysis of the primary outcome will be on an intention-to-treat basis.Discussion: If mesocolic excision in CD reduces postoperative disease recurrence and does not increase morbidity, this trial has the potential to change practice and reduce recurrence of CD after surgical resection.

The role of Kono‐S anastomosis and mesenteric resection in reducing recurrence after surgery for Crohn’s disease: a systematic review

“…Endoscopic recurrence was defined using the Rutgeerts score. Patients with a score of i,1, or less have low‐grade mucosal inflammation and are deemed at low risk of symptom recurrence [31]. Endoscopic recurrence was significantly lower in the Kono‐S group compared to the standard anastomosis group.…”

“…Nevertheless, our data do include one higher quality trial which, although follow‐up was too short for conclusions to be drawn about surgical recurrence, does mirror other studies that suggest endoscopic recurrence is reduced substantially with a Kono‐S anastomosis. We have identified two quality trials that are ongoing and these may allow more robust conclusions to be drawn [30,31].…”

“…Twenty-two citations underwent a full-text assessment with a further 11 records excluded. Of the 11 remaining included studies there were two incomplete RCTs [30,31]. All studies are summarized in Table 1 but Michelassi [30] and Li et al [31] have been excluded from subsequent text and tables.…”

“…Of the 11 remaining included studies there were two incomplete RCTs [30,31]. All studies are summarized in Table 1 but Michelassi [30] and Li et al [31] have been excluded from subsequent text and tables. A total of 896 patients were included.…”

Pathophysiology of Crohn’s disease inflammation and recurrence

“…These results suggested a pathogenic role for the mesorectal tissue in CD. In the footsteps of these assumptions, an international, multicenter, randomized controlled trial [ 95 ] is ongoing about the mesenteric excision surgery versus conservative limited resection in CD. Moreover, our group is running the PANACEA study (Pathophysiological, Nodal-based Approach for Crohn’s disease Excision), a pilot yet unpublished study, based on the belief that the majority of T-cells - especially memory T-cells – lies in lymph nodes [ 96 – 99 ].…”