A Multicenter Randomized Clinical Trial of Primary Anastomosis or Hartmann's Procedure for Perforated Left Colonic Diverticulitis With Purulent or Fecal Peritonitis

Oberkofler, Christian E.; Rickenbacher, Andreas; Raptis, Dimitri Aristotle; Lehmann, Kuno; Villiger, Peter M.; Buchli, Christian; Grieder, Felix; Gelpke, Hans; Decurtins, M; Tempia-Caliera, Adrien A.; Demartines, Nicolas; Hahnloser, Dieter; Clavien, Pierre‐Alain; Breitenstein, Stefan

doi:10.1097/sla.0b013e31827324ba

Cited by 322 publications

(271 citation statements)

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“…All RCTs with a proper study design according to the CONSORT guidelines were identified by a systematic literature search in peer-reviewed high impact journals in the last 3 years (2011-2013) [12][13][14][15] (Supplemental Digital Content 1: flow diagram, available at http://links.lww.com/SLA/A658). After contacting several centers in general, cardiac, and plastic surgery, we were granted full access to primary data and each patient record of 3 European trials [9][10][11] addressing different surgical interventions and diseases in compliance with our study design. The first trial focused on the rate of pancreatic fistulas after pancreaticoduodenectomy.…”

Section: Methodsmentioning

confidence: 99%

“…[9][10][11] Each postoperative event in each patient was assessed on site and graded according to the Clavien-Dindo classification, which is based on the treatment used to correct the postoperative complication. 3 For the development of the CCI, we used the established Clavien-Dindo classification system 3 for complications, adopting methods from operation-risk-index analysis in marketing research and developed a formula that considers any combination of complications.…”

Section: Data Collection and Primary Endpointmentioning

confidence: 99%

“…10 The study was designed to test whether the conventional Hartmann's procedure (HP: colonic resection with closure of the rectal stump and an end-colostomy) is comparable to a primary anastomosis (PA) with diverting ileostomy (Fig. 1) using the rate of overall complications, regardless of the severity, as the main endpoint.…”

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confidence: 99%

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Objective: To test whether the newly developed comprehensive complication index (CCI) is more sensitive than traditional endpoints for detecting between-group differences in randomized controlled trials (RCTs). Background: A major challenge in RCTs is the choice of optimal endpoints to detect treatment effects. Mortality is no longer a sufficient marker in studies, and morbidity is often poorly defined. The CCI, integrating all complications including their severity in a linear scale ranging from 0 (no complication) to 100 (death), is a new tool, which may be more sensitive than other traditional endpoints to detect treatment effects on postoperative morbidity. Methods: The CCI was tested in 3 published RCTs from European centers evaluating pancreas, esophageal and colon resections. To compare the sensitivity of the CCI with traditional morbidity endpoints, for example, presence of any (yes/no) or only the most severe complications, all postoperative events were assessed, and the CCI calculated. Treatment effects and sample size calculations were compared using the CCI and traditional endpoints. Results: Although RCTs failed to show between-group differences using any or most severe complications, the CCI revealed significant differences between treatment groups in 2 RCTs-after pancreas (P = 0.009) and esophageal surgery (P = 0.014). The CCI in the RCT on colon resections confirmed the absence of between-group differences (P = 0.39). The required sample sizes in trials are up to 9 times lower for the CCI than for traditional morbidity endpoints. Conclusions: This study demonstrates superiority of the CCI to traditional endpoints. The CCI may serve as an appealing endpoint for future RCTs and may reduce the sample size.

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Section: Methodsmentioning

confidence: 99%

Section: Data Collection and Primary Endpointmentioning

confidence: 99%

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The Comprehensive Complication Index

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“…More recently, the first randomized trial comparing Hartmann's procedure and primary anastomosis with diverting ileostomy for perforated diverticulitis with purulent or faecal peritonitis was published [43]. The trial reported no differences between the groups with regard to overall complications and morbidity and mortality for the initial colon resection, but the Hartmann's group had a significantly lower stoma reversal rate and significantly higher rates of serious complications following the reversal surgery.…”

Section: Primary Anastomosis Versus Hartmann's Proceduresmentioning

confidence: 99%

Management of Acute Diverticulitis and its Complications

Welbourn

Hartley

2014

Indian J Surg

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Colonic diverticular disease is a common condition, and around a quarter of people affected by it will experience acute symptoms at some time. The most common presentation is uncomplicated acute diverticulitis that can be managed conservatively with bowel rest and antibiotics. However, some patients will present with diverticular abscesses or purulent or faeculent peritonitis due to perforated diverticular disease. Whilst most mesocolic abscesses can be managed with percutaneous drainage alone, pelvic abscesses are associated with a higher rate of future complications and usually require percutaneous drainage followed by interval sigmoid resection. Patients who require emergency surgery for complicated acute diverticulitis most commonly undergo a Hartmann's procedure, although resection with primary anastomosis and laparoscopic peritoneal lavage have emerged as alternative treatment options for patients with purulent peritonitis in recent years. However, robust evidence from randomized trials is lacking for these alternative procedures, and the studies that have reported good outcomes from them have included carefully selected patient groups. There has been a move away from recommending elective prophylactic colectomy after two episodes of acute diverticulitis in the light of evidence that most patients will not experience a significant recurrence of their symptoms; elective surgery is indicated for those with ongoing symptoms, pelvic abscesses, complications-such as fistulating disease, strictures or recurrent diverticular bleeding-and those who are at high risk of perforation during future episodes, for example, due to immunosuppression, chronic renal failure or collagen-vascular diseases.

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“…71,72 The first randomised trial of Hartmann's procedure vs. primary anastomosis with a covering ileosotomy in patients with Hinchey III/IV disease reported no difference in initial mortality, but a reduction in length of stay, lower costs, fewer serious complications and greater stoma reversal rates in the primary anastomosis group. 73 The trial was stopped due to a low accrual rate and significant outcomes being shown in secondary endpoints. Recently, patients with generalised peritonitis with Hinchey grade I-III disease (Table 3) on CT scan have been managed with laparoscopic washout and drain placement with promising results reported from prospective and retrospective studies.…”

Section: Conservative/medicalmentioning

confidence: 99%

Review article: the pathogenesis and management of acute colonic diverticulitis

Humes

Spiller

2014

Aliment Pharmacol Ther

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SummaryBackgroundAcute diverticulitis, defined as acute inflammation associated with a colonic diverticulum, is a common emergency presentation managed by both surgeons and physicians. There have been advances in both the medical and the surgical treatments offered to patients in recent years.AimTo review the current understanding of the aetiology and treatment of acute diverticulitis.MethodsA search of PubMed and Medline databases was performed to identify articles relevant to the aetiology, pathogenesis and management of acute diverticulitis.ResultsThere are 75 hospital admissions per year for acute diverticulitis per 100 000 of the population in the United States. Recent reports suggest a 26% increase in admissions over a 7‐year period. Factors predisposing to the development of acute diverticulitis include obesity, smoking, diet, lack of physical activity and medication use such as aspirin and nonsteroidal anti‐inflammatory drugs. The condition is associated with a low mortality of about 1% following medical therapy, rising to 4% in‐hospital mortality in those requiring surgery. There is limited evidence on the efficacy of individual antibiotic regimens, and antibiotic treatment may not be required in all patients. The rates of recurrence reported for patients with acute diverticulitis following medical management vary from 13% to 36%. The surgical management of those patients who fail medical treatment has moved towards a laparoscopic nonresectional approach; however, the evidence supporting this is limited.ConclusionsFurther high‐quality randomised controlled trials are required of both medical and surgical treatments in patients with acute diverticulitis, if management is to be evidence‐based.

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A Multicenter Randomized Clinical Trial of Primary Anastomosis or Hartmann's Procedure for Perforated Left Colonic Diverticulitis With Purulent or Fecal Peritonitis

Abstract: This is the first randomized clinical trial favoring PA with diverting ileostomy over HP in patients with perforated diverticulitis.

Cited by 322 publications

References 40 publications

The Comprehensive Complication Index

The Comprehensive Complication Index

Management of Acute Diverticulitis and its Complications

Review article: the pathogenesis and management of acute colonic diverticulitis

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