IBD Surgery in the Biologic Therapy Era
The efficacy of the biologic agents must be balanced against the morbidity associated with their usage, and surgeons have been worried about the safety associated with the preoperative use of these medications in patients requiring elective or nonelective operations for their IBD. Beddy et al. from the Mayo Clinic authored a review of perioperative complications in IBD and the impact of preoperative biologic agents. They believed the evidence showed that recent biologic agent administration in a patient with Crohn's disease should not cause the surgeon to delay surgery or employ fecal diversion proximal to an anastomosis. However, they felt that patients with ulcerative colitis preoperatively managed with infliximab and immunosuppressant medications should undergo an alteration to the standard approach. Specifically, they advocated a three-stage rather than two-stage restorative proctocolectomy and ileal pouch-anal anastomosis (IPAA); the first operation would be a total or subtotal colectomy and creation of ileostomy that allows patients to be withdrawn from medications prior to performing the IPAA procedure. They proposed this approach in hopes of improving long-term ileal pouch function by decreasing the risk of short-term infectious complications attributed to combination therapy.
Concerns regarding postoperative infliximab usage have also been debated in patients with Crohn's disease. Accordingly, Regueiro et al. investigated the safety of infliximab compared to placebo administration initiated 2–4 weeks following intestinal resection. Study infusions were delivered at 0, 2, and 6 weeks followed by infusions every 8 weeks for 1 year. In the immediate postoperative period spanning 8 weeks, the groups experienced a similar number of adverse events (P = 0.68) and no complications related to wound healing or infection were noted. Overall, 22 adverse events were encountered in the 24 study patients throughout the duration of the study; no difference in the incidence or type of adverse event was noted between the two groups (P = 1.0).
Some of the concern about preoperative biologic agents voiced by surgeons involves nonelective surgery in patients with ulcerative colitis failing medical therapy. Ellis et al. reviewed 36 447 patients with ulcerative colitis listed in the Nationwide Inpatient Sample, and compared patients from the prebiologic agent period (1990–1996) to those from a later period (2000–2006). Colectomy and ileostomy were performed five times more commonly than a restorative proctocolectomy, regardless of the period studied. However, mortality associated with colectomy and ileostomy significantly increased from 3.8 to 4.6% (P = 0.0003) between the early and later eras. Moreover, this increase was principally secondary to increasing mortality in later years as evidenced by mortality rates of 3.6 versus 5.6% (P < 0.0001) in the years 1995–1996 versus 2005–2006, respectively. Conversely, no deaths occurred in the restorative proctocolectomy groups. It was also interesting that the bulk of surgery moved from the rural and urban nonteaching centers (56% in 1990–1996) to the urban teaching centers (67% in 2000–2006). The authors postulate that one potential cause for this increased mortality, especially seen in later years, was the introduction of biologic agent therapy that became US FDA-approved for use in moderately to severely active ulcerative colitis in September 2005.
Gainsbury et al. investigated whether infliximab is associated with increased operative morbidity in patients with ulcerative colitis undergoing an elective restorative proctocolectomy and IPAA. Over almost 4 years, 29 patients were treated with infliximab within 12 weeks of IPAA versus 52 control patients who underwent IPAA without recent infliximab administration. No operative mortality occurred, and postoperative complications were comparable between the infliximab group (44.8%) and noninfliximab group (44.2%) (P = 0.96). In addition, infectious complications were not significantly different between the infliximab group (17.2%) and noninfliximab group (26.9%) (P = 0.32).
Impact on Morbidity of Operation
The efficacy of the biologic agents must be balanced against the morbidity associated with their usage, and surgeons have been worried about the safety associated with the preoperative use of these medications in patients requiring elective or nonelective operations for their IBD. Beddy et al. from the Mayo Clinic authored a review of perioperative complications in IBD and the impact of preoperative biologic agents. They believed the evidence showed that recent biologic agent administration in a patient with Crohn's disease should not cause the surgeon to delay surgery or employ fecal diversion proximal to an anastomosis. However, they felt that patients with ulcerative colitis preoperatively managed with infliximab and immunosuppressant medications should undergo an alteration to the standard approach. Specifically, they advocated a three-stage rather than two-stage restorative proctocolectomy and ileal pouch-anal anastomosis (IPAA); the first operation would be a total or subtotal colectomy and creation of ileostomy that allows patients to be withdrawn from medications prior to performing the IPAA procedure. They proposed this approach in hopes of improving long-term ileal pouch function by decreasing the risk of short-term infectious complications attributed to combination therapy.
Concerns regarding postoperative infliximab usage have also been debated in patients with Crohn's disease. Accordingly, Regueiro et al. investigated the safety of infliximab compared to placebo administration initiated 2–4 weeks following intestinal resection. Study infusions were delivered at 0, 2, and 6 weeks followed by infusions every 8 weeks for 1 year. In the immediate postoperative period spanning 8 weeks, the groups experienced a similar number of adverse events (P = 0.68) and no complications related to wound healing or infection were noted. Overall, 22 adverse events were encountered in the 24 study patients throughout the duration of the study; no difference in the incidence or type of adverse event was noted between the two groups (P = 1.0).
Some of the concern about preoperative biologic agents voiced by surgeons involves nonelective surgery in patients with ulcerative colitis failing medical therapy. Ellis et al. reviewed 36 447 patients with ulcerative colitis listed in the Nationwide Inpatient Sample, and compared patients from the prebiologic agent period (1990–1996) to those from a later period (2000–2006). Colectomy and ileostomy were performed five times more commonly than a restorative proctocolectomy, regardless of the period studied. However, mortality associated with colectomy and ileostomy significantly increased from 3.8 to 4.6% (P = 0.0003) between the early and later eras. Moreover, this increase was principally secondary to increasing mortality in later years as evidenced by mortality rates of 3.6 versus 5.6% (P < 0.0001) in the years 1995–1996 versus 2005–2006, respectively. Conversely, no deaths occurred in the restorative proctocolectomy groups. It was also interesting that the bulk of surgery moved from the rural and urban nonteaching centers (56% in 1990–1996) to the urban teaching centers (67% in 2000–2006). The authors postulate that one potential cause for this increased mortality, especially seen in later years, was the introduction of biologic agent therapy that became US FDA-approved for use in moderately to severely active ulcerative colitis in September 2005.
Gainsbury et al. investigated whether infliximab is associated with increased operative morbidity in patients with ulcerative colitis undergoing an elective restorative proctocolectomy and IPAA. Over almost 4 years, 29 patients were treated with infliximab within 12 weeks of IPAA versus 52 control patients who underwent IPAA without recent infliximab administration. No operative mortality occurred, and postoperative complications were comparable between the infliximab group (44.8%) and noninfliximab group (44.2%) (P = 0.96). In addition, infectious complications were not significantly different between the infliximab group (17.2%) and noninfliximab group (26.9%) (P = 0.32).