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Accepted Manuscript Changing paradigms in the management of diverticulitis Nir Horesh, MD, Nir Wasserberg, MD, Andrew P. Zbar, MD FACS, Aviad Gravetz, MD, Yaniv Berger, MD, Mordechai Gutman, MD FACS, Danny Rosin, MD, Oded Zmora, MD PII: S1743-9191(16)30281-3 DOI: 10.1016/j.ijsu.2016.07.072 Reference: IJSU 2961 To appear in: International Journal of Surgery Received Date: 3 June 2016 Revised Date: 21 July 2016 Accepted Date: 26 July 2016 Please cite this article as: Horesh N, Wasserberg N, Zbar AP, Gravetz A, Berger Y, Gutman M, Rosin D, Zmora O, Changing paradigms in the management of diverticulitis, International Journal of Surgery (2016), doi: 10.1016/j.ijsu.2016.07.072. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. ACCEPTED MANUSCRIPT Changing paradigms in the management of diverticulitis Nir Horesh¹, MD; Nir Wasserberg², MD; Andrew P. Zbar¹, MD FACS; Aviad RI PT Gravetz¹, MD; Yaniv Berger¹, MD; Mordechai Gutman¹, MD FACS, Danny Rosin¹ MD, Oded Zmora¹, MD 1. Department of Surgery and Transplantation, Chaim Sheba Medical Center M AN US C Ramat Gan Israel (affiliated to the Faculty of Medicine, Tel Aviv University) 2. Department of Surgery B, Rabin Medical Center, Petach Tikva 49100; affiliated to Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv TE D 69978, Israel Corresponding author: Nir Horesh, M.D., Department of Surgery and Transplantations B, Sheba Medical Center, Tel-Hashomer, 52621, Israel; Tel: +972- AC C EP 507-316266; Fax: +972-3-5302316; E-mail: nir_horesh@hotmail.com Keywords – Diverticulitis, Emergency Surgery, Elective Surgery Abstract Word Count – 118 Article Word Count - 1869 ACCEPTED MANUSCRIPT 1/ Keywords – Diverticulitis, Emergency Surgery, Elective Surgery M AN US C Abstract RI PT Changing paradigms in the management of diverticulitis The management of diverticular disease has evolved in the last few decades from a structured therapeutic approach including operative management in almost all cases to a variety of medical and surgical approaches leading to a more individualized strategy. There is an ongoing debate among surgeons about the surgical management of diverticular disease, questioning not only the surgical procedure of choice, but also about D who should be operated and the timing of surgery, both in complicated and TE uncomplicated diverticular disease. This article reviews the current treatment of diverticulitis, with a focus on the indications and methods of surgery in both the EP emergency and elective settings. Further investigation with good clinical data is needed AC C for the establishment of clear guidelines. ACCEPTED MANUSCRIPT 2/ Introduction Diverticular disease is relatively common in the western world. Already in 1975, the estimated prevalence in the United States was about 60% in the over-65-year age RI PT group[1]. This rate has been steadily increasing concomitant with the increasing life expectancy of the general population. Accordingly, hospitals have witnessed a growing number of admissions for acute diverticular disease. In 1988, diverticulitis and its M AN US C complications accounted for 2.2 million hospitalizations in the United States, incurring cumulative health care costs of $2.5 billion[2]. Between 1988 and 2005, this figure rose by 26%[3]. These findings were echoed in studies from Europe, where acute diverticulitis accounts for more than 200,000 annual hospital admissions and poses a health burden exceeding €300 million[4]. The reported trends have prompted an ongoing search for novel, efficient and D cost-effective therapeutic strategies, and in the last 20 years, advances and innovations in TE imaging and surgical techniques have yielded significant changes in the management of diverticular disease. The paradigm has shifted from widely accepted stringent guidelines EP outlining specific indications for antibiotic administration, hospital admission, emergency surgery (including the procedure of choice), and elective surgery to a wide range of AC C available options at all stages of the disease. The current possibility of tailoring treatment to the individual patient has made sound surgical judgment and surgical experience of prime importance in this setting, and it is widely acceptable to choose the therapeutic intervention based on the specific patient, in order to lower the risks of morbidities and complications and improving patient quality of life. ACCEPTED MANUSCRIPT 3/ The aim of the present study was to review the important changes in the management of diverticulitis, with an emphasis on the indications for surgery in the RI PT emergency and elective settings. Diagnosis Clinical manifestations in acute diverticular disease vary, and depend mainly on M AN US C the severity of the inflammatory process of the disease and the presence or absence of complications. The most common symptom is left lower quadrant pain, occurring in 70% of cases, lasting for more than 24 hours in most cases [5]. Other manifestations include vomiting and nausea, changes in bowel movement and urinary symptoms may also be part of the clinical presentation. Physical findings comprise of left lower abdominal tenderness in most cases, abdominal distension and a palpable mass are also D common, mainly in acute diverticulitis complicated by an abscess formation [6]. Low TE grade fever with mild leukocytosis is common [7], but studies have showed that almost half of all patients with acute diverticulitis have normal WBC levels [8]. EP Although the main clinical manifestation of diverticulitis is lower left abdominal pain, it has a wide differential diagnosis. This is often a misleading symptom that can AC C result in misdiagnosis in 34% to 68% of patients[9-11]. Also, caregivers today must acknowledge that though left sided diverticulitis is much more common in western populations, in many Asian countries and eastern populations the predominant presentation of acute diverticulitis is seen on the right side of the colon [12-14]. Therefore, in suspected cases, clinicians usually base the diagnosis on imaging studies, particularly computed tomography (CT) which has been found to have high sensitivity ACCEPTED MANUSCRIPT 4/ and specificity for acute diverticulitis[15, 16]. The role of colonoscopy in diagnosis is mainly to confirm the presence of diverticuli as seen on computed tomography, mainly to exclude malignant findings, a task often difficult for the radiological studies. However, RI PT the need for endoscopic evaluation following an attack of acute diverticulitis is controversial, as some studies [17, 18], including one performed in our institute demonstrated no clear advantage for colonoscopy following an episode of acute M AN US C diverticulitis [19]. Staging Staging is used in various diseases to score severity and aid clinicians in treatment decisions. Hinchey et al. [20] developed the first staging system for perforated diverticulitis in 1978. The classification relates to infectious and inflammatory spread D following colonic perforation, escalating from a small pericolic abscess (Grade 1) up to TE fecal peritonitis (Grade 4). It is still commonly used by physicians and aids with therapeutic decisions. Almost 20 years after Hinchey first described his classification, EP Sher et al [21] modified the Hinchey score to account for the increasing use of CT as a diagnostic modality, and it subsequently became the most common staging method AC C applied by surgeons for acute diverticulitis worldwide. Several alternative systems have been introduced as well in the interim, such as the Köhler classification, which is based on symptom severity and presentation[22], and the classification of Ambrosetti et al. [23], which uses CT findings as the reference for selecting treatment. ACCEPTED MANUSCRIPT 5/ Treatment Uncomplicated diverticulitis Mild or moderate diverticulitis is usually treated conservatively. Traditionally, RI PT most patients are hospitalized to receive intravenous antibiotics against aerobic and anaerobic microbial agents and fluids along with mandatory bowel rest. However, several recent studies have shown that in the absence of significant comorbidities, outpatient M AN US C management with oral antibiotics is equally safe and effective [24-30]. In a randomized trial of outpatient management of uncomplicated diverticulitis, Biondo et al [31] reported excellent results and reduced health care-costs. These findings were supported by a systematic review wherein outpatient management led to a decrease of more than 80% in health-care costs in some cases with no loss of effectiveness [32]. Nevertheless, the inhospital administration of intravenous antibiotics, usually a combination of anti-aerobic D and anaerobic bacteria such as Fluoroquinolone and Metronidazole [33] or Amoxicillin- TE clavulanate [34] is still warranted in patients with comorbidities or a more severe clinical and radiologic presentation[35]. The latter is also true for right sided diverticulitis, which EP according to several studies in recent years usually responds to a non-operative treatment, with a low recurrence rate after the first attack [36, 37]. AC C There is also evidence suggesting that uncomplicated diverticulitis may be treatable without antibiotics at all [38-40]. Chabok et al [38] conducted a multicenter trial in which patients were randomized to receive hospital treatment with or without antibiotics. They found no between-group differences in complication rate, length of hospital stay, or recurrence. ACCEPTED MANUSCRIPT 6/ Complicated acute diverticulitis Emergency surgery About 15% to 25% of cases of acute diverticulitis are associated with RI PT complications that require surgery. Until recently, peridiverticular abscess was the main indication for surgery, but thanks to improvements in imaging and drainage techniques, it is now usually manageable by percutaneous drainage and intravenous antibiotics[41]. M AN US C Today, the main indication for surgery is colonic perforation, which can lead to acute peritonitis and subsequent significant morbidity and occasional mortality. Up to the early 1980s colonic perforation was treated by a standard three-stage procedure that included a diverting proximal colostomy and drainage of the perforation site in the acute setting to alleviate sepsis, followed by resection of the involved colonic segment in an elective setting, and later, colostomy closure[42]. Despite the considerable intervals D between the steps to allow for recovery, mortality rates were high[43]. Thereafter, TE perioperative care improved, leading to the introduction of the two-stage Hartmann procedure [44, 45]: primary resection of the perforated segment and end-colostomy EP followed by colostomy closure [46, 47]. The Hartmann procedure was associated with better outcome and fewer complications than other surgical techniques, although there was no AC C decrease in mortality rates[48]. In 2000, the American Society of Colon and Rectal Surgeons recommended the Hartmann procedure as the gold standard for the treatment for acute perforated diverticular disease with peritonitis[49]. Another viable option is resection of the diseased segment with primary anastomosis and diverting loop ileostomy. This approach has been associated with a favorable outcome in selected low-risk, hemodynamically stable patients, but there are as ACCEPTED MANUSCRIPT 7/ yet no large-scale randomized controlled trials. Oberkofler et al.[50] compared patients with Hinchey class III-IV perforation who were randomized to undergo primary resection with anastomosis or the Hartmann procedure. They found that the primary anastomosis RI PT group was characterized by a lower rate of stoma reversal fewer serious complications, less operating time, shorter hospital stay, and lower health care costs, although the overall complication and mortality rates were similar to the Hartmann procedure group. M AN US C Several studies have suggested the incorporation of laparoscopic techniques during surgery for colonic perforation due to acute diverticulitis. Studies of the benefits of peritoneal laparoscopic lavage and drainage in these cases reported excellent outcomes with less risk compared with the Hartmann procedure[51-57], especially in stable patients with less severe peritonitis (Hinchey class III)[58, 59]. However, reviews and meta-analyses that included all these studies pointed to the importance of good patient selection and the D need for further investigation to confirm the place of laparoscopic peritoneal lavage and TE drainage in this setting [51, 56, 60, 61]. A small retrospective case series in our department recently showed that laparoscopic peritoneal lavage and drainage resolved the acute EP symptoms in all patients, but 30% required additional surgery (91). In 2015, Vennix etl al [62] published the results of the LOLA arm, part of the LADIES Trial [63], comparing AC C two randomized patient groups, treated with laparoscopic lavage and drainage or resection with primary anastomosis, concluding that laparoscopic lavage has no advantage over resection and primary anastomosis. Furthermore, the results of another randomized controlled study, the SCANDIV trial [64], comparing two groups treated surgically with laparoscopic lavage or colonic resection, demonstrated that laparoscopic ACCEPTED MANUSCRIPT 8/ lavage had more post-operative complications and required a higher rate of additional surgical intervention. At present, for complicated diverticulitis in unstable patients with fecal peritonitis, RI PT Hartmann’s procedure continues to be the surgical method of choice [65-67]. M AN US C Elective Surgery Elective surgery has played an important role in the definitive treatment of acute diverticulitis, although the indications have changed dramatically in recent years. Traditionally, elective surgery was recommended after a second episode of acute diverticulitis and for young patients after a solitary attack in order to prevent complicated diverticulitis and the possible need for riskier emergency surgery with a temporary D colostomy. Approximately one-third of patients with acute diverticulitis meet these TE criteria [22, 68, 69]. However, several sentinel studies have raised concerns about these guidelines. The systematic review of Janes et al [70] failed to find evidence supporting the EP recommendation for surgery after two attacks of acute diverticulitis, and the decisionanalysis study of Salem et al [71] showed that patients operated after four episodes of acute AC C diverticulitis had lower mortality rates, fewer colostomies, and lower health-care costs than patients operated after two episodes. Accordingly, most surgeons today determine the need for surgery on a case-by-case basis, depending on certain variables[72]. The most recent guidelines for the surgical management of diverticulitis, published in 2014[73], recommend that elective surgery be performed in the presence of ongoing complications of acute diverticulitis, such as colocutaneous, colovesicle, or colovaginal fistulas, or after ACCEPTED MANUSCRIPT 9/ recurrent uncomplicated episodes of acute diverticulitis that adversely impact the patient’s quality of life. Thus, the chances that every recurrent episode will be followed by emergency surgery with temporary colostomy are low and probably within the range RI PT of the risk of complications of elective surgery itself [74-76]. Nevertheless, the occurrence of a series of recurrent symptomatic attacks probably warrants surgical treatment. The need for elective surgical resection following conservatively treated M AN US C complicated diverticulitis has also been challenged. As noted, the improvements in invasive radiology and broad-spectrum antibiotics have considerably raised the likelihood of complete resolution of peridiverticular abscess and local perforation with nonoperative treatment alone[76], thereby lowering the likelihood of a recurrent attack warranting emergency surgery. This is probably also true for episodes of perforated diverticulitis requiring lavage and drainage, which has been associated with a low D recurrence rate [77-79]. Other factors contributing to the decision to use a more aggressive TE therapeutic approach include patient age and underlying comorbidities [78, 80]. Several studies recommend elective surgery in immune-compromised patients [81, 82], but a recent EP publication by Biondo et al [83] demonstrated that it is unnecessary if medical treatment was successful. Further randomized trials are needed to determine the definitive AC C guidelines for surgical treatment of acute diverticulitis. The number of elective resections for diverticulitis performed laparoscopically has been increasing since the late 1990s. Laparoscopic surgery in the treatment of acute diverticulitis has been associated with several benefits [80, 84-90]. Klarenbeek et al. [91] prospectively compared laparoscopic and open sigmoid resection for acute diverticulitis and found that laparoscopic surgery was associated with shorter hospital stay, fewer ACCEPTED MANUSCRIPT 10/ complications, and attenuated pain. A meta-analyses including more than 2800 patients published by Sidiqqui et al [92] in 2010, compared laparoscopic surgery and open surgery for diverticular surgery. Laparoscopy was superior in surgical outcome including RI PT decreased rates of surgical of surgical wound infection, blood transfusions and paralytic ileus. a systemic review by Gaertner et al showed that laparoscopy had reduced morbidity, shorter hospital stay and lower costs [93] when compared with open surgery. In a fairly low complication rate of 7.6%. M AN US C a recent prospective trial, Schwandner et al. [94] reported a conversion rate of 6.8%, with To summarize, we believe that the treatment for acute diverticulitis should be tailored to the clinical status of the patient. Outpatient management should be considered in selected patients with uncomplicated diverticulitis, mainly mildly ill and younger D patients without significant comorbidities. Hospitalization should be considered in all TE patients with complicated diverticular disease and patients with uncomplicated diverticulitis but without clinical response to oral treatment, requiring intravenous EP antibiotics and close up medical follow up. Surgical treatment should also be considered on a patient to patient basis. In the AC C emergency setting, the clinical status of the patient and the radiological classification should play a role when deciding on the surgical strategy. Though the Hartmann's procedure is still the most common procedure for colonic diverticular perforation, there is enough evidence that most patients with a pelvic or an intra-abdominal abscess could be managed without surgery. These patients might be in need of a percutaneous drainage in large abscesses or if they don't improve clinically with antibiotics alone. Emergency ACCEPTED MANUSCRIPT 11/ surgery should be considered in all patients with a Hinchey class 3 complicated diverticulitis in order to achieve septic source control. The decision for a laparoscopic vs. open surgery should depend on the surgical capabilities of the surgeon and on the clinical RI PT status of the patient. Younger patients with less comorbidities could be good candidates for laparoscopic surgery including peritoneal lavage and drainage in Hinchey Class III perforations or for a resection with primary anastomosis in capable hands. We M AN US C recommend that all patients with fecal peritonitis should undergo bowel resection with proximal diversion. In the elective setting, surgery should be offered to patients with recurrent attacks and that the disease has a significant impact on their quality of life, including multiple hospital admissions or constant abdominal pain. Elective surgery should also be offered to patients presenting with complications including fistula and bowel strictures. D Immunocompromised patients are also prone for diverticular disease complications and TE therefore should also be considered for surgery. Finally, the decision should be based on the patients' clinical status after a joint discussion about the possible outcomes of the EP surgical intervention. AC C Conclusion The management of diverticular disease has changed notably in recent years and is still evolving, thanks to advances in diagnostic and nonoperative interventional capabilities. Surgical treatment can now be avoided in many cases that would have routinely been approached surgically in the past. The availability of laparoscopic techniques has also changed the treatment paradigm for patients with recurrent episodes ACCEPTED MANUSCRIPT 12/ of acute diverticulitis to a more individualized approach focusing mainly on quality of life. 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ACCEPTED MANUSCRIPT 66. 67. 68. 69. 70. 71. 72. 73. 74. 75. 76. 77. 78. 79. 80. RI PT M AN US C 65. D 64. TE 63. EP 62. Cirocchi, R., et al., Treatment of Hinchey stage III-IV diverticulitis: a systematic review and meta-analysis. Int J Colorectal Dis, 2013. 28(4): p. 447-57. Vennix, S., et al., Laparoscopic peritoneal lavage or sigmoidectomy for perforated diverticulitis with purulent peritonitis: a multicentre, parallel-group, randomised, openlabel trial. Lancet, 2015. 386(10000): p. 1269-77. Swank, H.A., et al., The ladies trial: laparoscopic peritoneal lavage or resection for purulent peritonitis and Hartmann's procedure or resection with primary anastomosis for purulent or faecal peritonitis in perforated diverticulitis (NTR2037). BMC Surg, 2010. 10(29): p. 1471-2482. Schultz, J.K., et al., Laparoscopic Lavage vs Primary Resection for Acute Perforated Diverticulitis: The SCANDIV Randomized Clinical Trial. Jama, 2015. 314(13): p. 1364-75. Gawlick, U. and R. 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Scheidbach, H., et al., Laparoscopic approach to treatment of sigmoid diverticulitis: changes in the spectrum of indications and results of a prospective, multicenter study on 1,545 patients. Dis Colon Rectum, 2004. 47(11): p. 1883-8. Stevenson, A.R., et al., Laparoscopically assisted anterior resection for diverticular disease: follow-up of 100 consecutive patients. Ann Surg, 1998. 227(3): p. 335-42. Klarenbeek, B.R., et al., Laparoscopic sigmoid resection for diverticulitis decreases major morbidity rates: a randomized control trial: short-term results of the Sigma Trial. Ann Surg, 2009. 249(1): p. 39-44. Siddiqui, M.R., et al., Elective laparoscopic sigmoid resection for diverticular disease has fewer complications than conventional surgery: a meta-analysis. Am J Surg, 2010. 200(1): p. 144-61. Gaertner, W.B., et al., The evolving role of laparoscopy in colonic diverticular disease: a systematic review. World J Surg, 2013. 37(3): p. 629-38. Schwandner, O., et al., Laparoscopic colectomy for recurrent and complicated diverticulitis: a prospective study of 396 patients. Langenbecks Arch Surg, 2004. 389(2): p. 97-103. AC C 81. ACCEPTED MANUSCRIPT Highlights AC C EP TE D M AN US C RI PT • This review outlines the most significant changes that diverticular disease management has seen in recent years • The review gives physicians an updated view on the most current studies of outpatient and inpatient treatment for acute diverticulitis • The review focus on the surgical management and the indications for surgery, both in the emergency and the elective setting