The Complicated IBD Patient: Clinical Case Marathon Dig Dis 2014;32(suppl 1):110–115 DOI: 10.1159/000367860

Refractory Distal Ulcerative Colitis: Is Proctocolectomy Always Necessary? Michele Carvello Marco Montorsi Antonino Spinelli Colorectal and IBD Surgery Unit, Department of Surgery, Humanitas Clinical and Research Center, Rozzano, Italy

Abstract Refractory distal ulcerative colitis (RDUC) is defined as persistence of symptoms caused by endoscopically proven colonic inflammation located at the rectum or left colon despite oral/topical steroids and 5-ASA. RDUC affects a small subset of patients and is associated with chronic disabling symptoms and increased social/medical costs. Moreover, patients with long-standing ulcerative colitis (UC) carry an elevated risk of developing colorectal cancer and colonic mucosa high-grade dysplasia. Alternative medical strategies in steroid refractory disease are unlikely to provide durable remission in all patients, carry potential severe side effects and, as immunosuppressants, the risk of other neoplasms, and may increase the short-term complication rate when surgery is finally required. Restorative proctocolectomy with ileal pouch-anal anastomosis (RP-IPAA) allows the complete removal of the diseased rectum and colon, virtually eliminating the risk of malignant transformation and reestablishing

© 2014 S. Karger AG, Basel 0257–2753/14/0327–0110$39.50/0 E-Mail [email protected] www.karger.com/ddi

intestinal continuity with continence preservation. Since the introduction of this surgical procedure, morbidity and mortality rates have been drastically reduced. Despite the still notable rate of surgical complications, long-term quality of life assessment has shown excellent results in nearly all patients who have undergone RP-IPAA, comparing well with the general population. Furthermore, when performed for distal UC, RP-IPAA produces similar surgical outcomes with respect to pancolitis. In conclusion, RP-IPAA should always be considered in patients with RDUC, and multidisciplinary counseling should provide patients clear information about the advantages of surgery and possible complications as well as the chance to achieve disease remission with medical therapy. © 2014 S. Karger AG, Basel

Introduction

Persistent active ulcerative colitis (UC) accounts for significant morbidity and strongly impacts the quality of life (QoL) of affected patients compared to other chronic diseases [1]. It has been observed that active-disease patients have worse health-related QoL values compared to sympAntonino Spinelli, MD, PhD Head, Colorectal and IBD Surgery Unit, Department of Surgery Humanitas Clinical and Research Center via Manzoni 56, IT–20089 Rozzano (Italy) E-Mail antonino.spinelli @ humanitas.it

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Key Words Refractory distal ulcerative colitis · Medical therapy · Restorative proctocolectomy · Ileal pouch-anal anastomosis · Cancer risk

Refractory Distal Ulcerative Colitis

Cancer Risk

Although the risk extent has been debated [6, 11–13], UC increases the chances of developing HGD and CRC compared to the normal population [6, 11, 14–16]. The risk is strongly associated to the duration and phlogistic load of the disease [15, 17]. Indeed in a case-control study, the histological evidence of active inflammation was found to be an independent risk factor for CRC [17]. Furthermore, the tumor site is related to active-disease location [18]. The prevalence of CRC in UC is reported to be 3.7% [6]. The rate increases over time after diagnosis and the probability of developing CRC in UC patients is 2% at 10 years, 8% at 20 years and 18% at 30 years [6, 14]. Even though patients with pancolitis or colitis extending to the splenic flexure have a higher risk of developing CRC compared to left-sided colitis [7], in endoscopic surveillance programs for UC the majority of dysplastic lesions identified were detected in the rectosigmoid tract [19]. In this light, since dysplastic change in colonic mucosa is associated with an increased risk of CRC transformation [20], careful and relative aggressive treatment should arguably be pursued in RDUC. Indeed, in a retrospective study of 263 proctocolectomies, 27 of which were for distal disease, undiagnosed severe dysplasia was detected in the bowel specimens of 2 patients [21].

Medical Therapy

Conventional medical therapy for distal UC includes topical/oral 5-ASA and topical/oral steroids [7]. The patients rarely develop signs of systemic toxicity, usually only when the disease extends proximally and require hospital admission for intravenous steroid administration [7]. After RDUC has been diagnosed, there are a few alternative medical therapy options, but these have a poor evidence base [9, 22, 23]. A multicenter study assessing infliximab induction therapy reported clinical remission of rectal symptoms in 9 out of 13 patients with refractory proctitis after 17 months. However, endoscopy, which was performed in 7 of these patients, detected mucosal improvement in 4 patients, persistent moderate disease activity in 2 patients and no improvement in the last patient [24]. Even though other investigators have shown interesting results with infliximab therapy intensification in order to maintain remission in responders [25], it has been suggested that in cases which ultimately require surgery because of drug failure, preoperative infliximab Dig Dis 2014;32(suppl 1):110–115 DOI: 10.1159/000367860

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tom-free patients [2–4]. As a result, health-related issues caused by UC have a heavy impact on work productivity and on social/economic costs [5]. Moreover, patients with long-standing UC have a heightened risk of developing colorectal cancer (CRC) and high-grade dysplasia (HGD) with respect to the background population [6]. One third of the patients with UC suffer from distal disease, with inflammation mainly located at the rectum and descendent-sigmoid colon. The majority of these patients respond well to conventional medication (topical/ oral 5-ASA, oral steroids) [7]. However, a few patients may present with medically refractory rectal hemorrhage and continuous inflammation causing rectal narrowing with subsequent defecation urgency and incontinence [8]. This condition, defined as refractory distal ulcerative colitis (RDUC), is characterized by endoscopically proven active disease located at the rectum or left colon despite conventional medical therapy [7]. This particular situation often remains a clinical challenge [9]. The patients rarely require hospital admission for systemic toxicity [7]. More frequently, though, they suffer a prolongation of chronic disabling symptoms with a subsequent poor QoL [9]. These patients perceive their disease as less severe. They are often managed by a general practitioner with less need for specialist resources and subsequent risk of disengagement from the IBD team. Thus, timely recognition and treatment of these patients are pivotal for avoiding unnecessary prolongation of chronic troublesome manifestations. The European Crohn’s and Colitis Organization (ECCO) guidelines report that refractory disease represents an indication for surgical treatment [7]. However, given the modest bowel segment affected and the relative low risk of life-threatening events, patients with RDUC and their managing clinicians are usually more hesitant to accept a major surgery than in cases of extensive disease [9]. Medical therapies as an alternative in steroid refractory disease have been investigated, but none of these have been able to provide clinical remission or mucosal restoration in all patients [9]. RP-IPAA is considered safe and effective because it removes the diseased bowel, thus preserving intestinal continuity and reducing the risk of cancer [10]. The aim of this review is to highlight the advantages of RP-IPAA for this very small subset of patients as the treatment of choice over continuing medical therapy and to revise the literature in terms of surgical short- and longterm outcomes as well as impact on postoperative QoL in order to contribute to a well-balanced multidisciplinary discussion and therapeutic decision.

Surgery

RP-IPAA has been reported by a number of authors to be a safe approach with dependable functional outcome [31–33]. This procedure has gained popularity since its introduction in 1978 by Parks and Nicholls [34] for the treatment of UC. The role and the indication of surgery are undebatable for acute severe colitis or in case HGD or CRC arises from the colonic mucosa [35]. In these cases restorative proctocolectomy is necessary and clearly provides explicit advantages. In the setting of medical RDUC, the risk/benefit balance might be more difficult to understand. Indication and Advantages of Surgery in RDCU RP-IPAA is able to eliminate the disease and preserve fecal continence in the majority of patients, thus avoiding the problem of a permanent stoma. It is the accepted surgical procedure for chronic UC [32, 33] and is outlined in the ECCO UC guidelines [35] as the standard of care. Few specific studies on outcomes of RP-IPAA for distal colitis are available [21, 36]. However, in a case series of 177 patients undergoing RP-IPAA for UC, 20 of which were for distal UC, the results of patients with distal disease were shown to be similar to those with pancolitis with respect to early complications, number of bowel movements and continence, as well as the rate of pouchitis [36]. This finding confirms that the site of disease does not affect the outcome of surgery. The operation has traditionally been performed through a midline incision, as a 1- or 2-stage procedure in the elective setting [32, 33, 37]. A protective ileostomy is generally performed, although in highly selected cases the procedure might be done without a diverting stoma [38]. 112

Dig Dis 2014;32(suppl 1):110–115 DOI: 10.1159/000367860

In the minimally invasive surgery era, the possibility of performing this complex procedure by laparoscopic or hybrid technique has gained the interest of many colorectal surgeons [39–43]. However, the minimally invasive procedure is generally performed in specialized referral centers with strong colorectal laparoscopic experience [42–45]. Comparisons between the open and laparoscopic approaches did not show significant differences in terms of short-term postoperative outcomes and mortality [45]. Although operative time is longer for the laparoscopic approach, the hospital stay is shorter in the latter. Complication rate, functional result and QoL were similar for the two techniques [46]. RDUC patients, who are usually not affected by systemic disease toxicity, are good candidates to enjoy the advantages of shorter postoperative recovery and hospital stay, better cosmetic result, and lower risk of postoperative adhesion and incisional hernia offered by the minimally invasive approach. Short- and Long-Term Outcome Mortality for RP-IPAA can be as low as 0.4% in experienced tertiary centers [32]. However, the postoperative morbidity rate can be relevant, especially when compared to other colorectal procedures. Anastomotic leakage and possible pelvic sepsis have been reported by various studies with a range of 7–20% [37, 47–51]. When nonpouchand pouch-related morbidities are included, the overall incidence of complications can range from 13 to 62%. These usually include small bowel obstruction, pulmonary infection, myocardial events, infection of the urinary tract, deep venous thrombosis, incisional hernia, pouch hemorrhage and dehydration secondary to high stoma output [33, 48–54]. Despite the morbidity rate cited above, tertiary referral centers have shown a significant reduction in complication rates over two decades of case series [32, 37]. Indeed Fazio et al. [32] reported a significant reduction in pouch removal, long-term complications and nonfunctional pouch rate in a 10-year consecutive series of patients undergoing RP-IPAA. Inflammation of the ileal reservoir (pouchitis) is the most frequent complication of RP-IPAA for UC [37, 55– 59]. The incidence rate of pouchitis can be as high as 50% at the 10-year follow-up [37], and most commonly occurs in the first year. Possible risk factors for pouchitis are extensive UC, extraintestinal manifestations and nonsteroidal anti-inflammatory drug use [59]. It is important, however, to consider that pouchitis usually has a brief course (2–3 days), responds well to antibiotics and occurs once or twice after surgery in nearly all patients, with Carvello/Montorsi/Spinelli

 

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treatment might increase the risk of short-term postoperative complications [26]. A prospective pilot study has shown effectiveness of topical rectal tacrolimus with 6 out of 8 patients achieving remission, but additional case control trials are needed [27]. In steroid RDUC, intravenous cyclosporine is reported to be effective [28, 29]. However, it can be associated with potential severe side effects (nephrotoxicity, opportunistic infections, seizures) [30]. In summary, alternative medical strategies in steroid refractory disease are unlikely to provide durable remission in all patients, carry potential severe side effects and, as immunosuppressants, the risk of other neoplasms [29], and it may increase the short-term complication rate when surgery is finally required.

QoL after Surgery Over the years the goal of such complex surgery has changed from bringing down the mortality rate to minimizing complications and finally the amelioration of the QoL. Despite the short- and long-term complications described above, RP-IPAA provides excellent functional results and long-term QoL comparable with the background population [10]. Furthermore, durable patient satisfaction after surgery is often highlighted in studies that analyze QoL after RP-IPAA [10, 56, 63, 64]. Even 8 years after surgery almost half of the patients undergoing RP-IPAA would have a pouch again, would recommend surgery to other patients and wished they had had surgery earlier [10]. Few studies have focused on QoL after RP-IPAA [21, 36] – specifically for distal UC. In one of these, the comparison of performance status with respect to sexual function, professional life, ability to travel and recreation showed improvement between preoperative and postoperative scores 1 year after surgery [21]. The same study reported a postoperative reduction in stool frequency and defecation urgency with improvement in continence. However, another report analyzing the QoL of patients up to 20 years after surgery showed that a slight reduction in continence performance at 10 years after surgery, but remained stable at the 15- and 20-year follow-up [56].

Conclusion

Distal colitis refractory to medical therapy has a strong impact on the QoL of affected patients and on the overall social cost of the disease. Furthermore, long-standing UC represents a risk factor for CRC and HGD development. Refractory Distal Ulcerative Colitis

Medical therapy usually provides symptom control in the majority of patients with distal UC. Alternative medical therapies in disease refractory to conventional medication are unreliable in providing restoration of distal mucosal lesions. RP-IPAA, although burdened by notable incidence rates of short- and long-term postoperative complications, has the advantage of removing the diseased organ, minimizing the cancer risk and preserving the normal intestine route without the issue of a permanent stoma. The possibility of performing RP-IPAA with a laparoscopic approach may provide the patient the benefit of an early postoperative recovery as well as a better cosmetic result. Moreover, laparoscopy has been shown to overcome the sexual function issue in women reported in open-approach studies. Overall QoL after surgery is improved and comparable with the general population in the majority of patients undergoing RP-IPAA with longterm reasonable outcomes. In conclusion, multidisciplinary counseling with regard to the surgical option should be provided for RDUC patients with proper timing and with clear analysis of the pros and cons of surgery and the expectancy of providing disease remission with medical therapy. What still remains debatable is whether to use a 2staged or 3-staged RP-IPAA procedure for RDUC patients. When a 2-staged procedure is performed, there is a higher risk of surgical complications, which is also increased by preoperative medical therapy (steroid or immunosuppressants) [65, 66]. Conversely, with a 3-staged procedure, the risk of early surgical complication is thought to be lower. However, the actual diseased colon and rectum remain in situ when subtotal colectomy is performed. Nevertheless, the manifestation of distal active disease can be attenuated by the protective stoma. It has recently been reported that the complication rate when comparing a 2-staged procedure with a 3-staged procedure is only related to surgeon experience with no significant difference in terms of emergent status, use of steroids or use of anti-TNF agents [67]. However, given that RP-IPAA for RDUC patients is often performed in an elective setting, we would advise to properly and carefully revise nutritional status as well as medical history of each single patient, possibly dampening steroid therapy and obtaining a 1-month anti-TNF-free window before a 2-staged RP-IPAA. Disclosure Statement The authors declare that there are no conflicts of interest pertaining to this study.

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minimal impact on the QoL and functional result [56]. Conversely, the chronic pouchitis rate can be as low as 5–8% in referral centers [32, 56]. RP-IPAA has been found to be associated with erectile dysfunction and retrograde ejaculation in 2–3% of male patients [60]. Conversely, a considerable rate (22–40%) of dyspareunia or sexual dysfunction has been observed in women with a relevant decline in fertility [60]. Some authors have suggested that intraperitoneal adhesion can be the cause of tubular blockage-related infertility [60]. The laparoscopic approach might reduce the chance of postoperative peritoneal adhesions [61]. Indeed, it has recently been shown in a cross-sectional study that after laparoscopic IPAA there is a reduction of time to the first natural pregnancy and an increment in pregnancy probability compared to open IPAA [62].

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Refractory distal ulcerative colitis: is proctocolectomy always necessary?

Refractory distal ulcerative colitis (RDUC) is defined as persistence of symptoms caused by endoscopically proven colonic inflammation located at the ...
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