Bastiaan R. Klarenbeek

Laparoscopic sigmoid resection for diverticulitis decreases major morbidity rates: a randomized control trial. Short-term Results of the Sigma-trial

Background:No randomized controlled trial has compared laparoscopic sigmoid resection (LSR) to open sigmoid resection (OSR) for symptomatic diverticulitis of the sigmoid colon. This study tested the hypothesis that LSR is associated with decreased postoperative complication rates as compared with OSR. Methods:This was a prospective, multicenter, double-blind, parallel-arm, randomized controlled trial. Eligible patients were randomized to either LSR or OSR. Endpoints included postoperative mortality, and complications were classified as major and minor. The generator of the allocation sequence was separated from the executor. Blinding was ensured using an opaque wound dressing to cover the abdomen. Symptomatic diverticulitis of the sigmoid colon was defined as recurrent disease Hinchey I, IIa, IIb, symptomatic stricture, or severe rectal bleeding. The decision to discharge patients was made by independent physicians blind to the allocation sequence. Data were analyzed according to the intention to treat principle. Results:From 2002 to 2006, 104 patients were randomized in 5 centers. All patients underwent the allocated intervention. Fifty-two LSR patients were comparable to 52 OSR patients for gender, age, BMI, ASA grade, comorbid conditions, previous abdominal surgery, and indication for surgery. LSR took longer (P = 0.0001) but caused less blood loss (P = 0.033). Conversion rate was 19.2%. Mortality rate was 1%. There were significantly more major complications in OSR patients (9.6% vs. 25.0%; P = 0.038). Minor complication rates were similar (LSR 36.5% vs. OSR 38.5%; P = 0.839). LSR patients had less pain (Visual Analog Scale 1.6; P = 0.0003), systemic analgesia requirement (P = 0.029), and returned home earlier (P = 0.046). The short form-36 questionnaire showed significantly better quality of life for LSR. Conclusions:LSR was associated with a 15.4% reduction in major complication rates, less pain, improved quality of life, and shorter hospitalization at the cost of a longer operating time.

Indications for elective sigmoid resection in diverticular disease

Introduction:To prevent an acute surgery, classic indications for elective sigmoid resections concerning diverticulitis have usually been based on the number of recurrent episodes. Since 2005 these indications have been challenged, primarily because the majority of patients first present themselves with acute complications at their first episode. Methods:Between 1990 and 2000, a cohort analysis was conducted involving all patients admitted to the VU University Medical Center with the diagnosis of diverticulitis, with a follow-up until January 2009. To identify those patients who might benefit from elective sigmoid resection, several risk factors were analyzed. Results:Of 291 patients examined, 111 (38%) were treated conservatively and 180 (62%) underwent surgery, of which 108 acute and 72 elective. The conservatively treated episodes of diverticulitis showed a recurrence rate of 48% (88 patients). Indications for elective surgery were recurrent attacks of diverticulitis with persistent complaints (36%), complaints of stenosis (40%), fistula (14%), persistent abscesses (3%), and recurrent diverticular bleeding (7%). Of the 74% of the patients approached laparoscopically, the overall morbidity was 22% with no mortality. The main indication for an AO was perforation with general peritonitis, holding for 57% of the acutely operated patients. Other indications were abscesses (22%), stenosis with obstruction (11%), failure of conservative therapy (6%), or diverticular bleeding (4%). Hartmanns procedure was the most frequently performed procedure (58%). This acutely operated population was associated with high morbidity (56%) and mortality (13%), perforation leads to 10% mortality and other causes to 3%. Of those patients undergoing acute surgery, 20% had a history of diverticulitis. Moreover, risk factor analysis showed that those patients having one or more of the following indications: (1) using immunosuppression therapy, (2) having chronic renal failure, or (3) collagen-vascular diseases, had a significant 5-fold greater risk (36% vs. 7%) of a perforation in recurrent episodes of diverticulitis. Conclusion:In the treatment of diverticular disease, indications for an elective sigmoid resection should not be based on the number of episodes only. Clear indications for elective sigmoid resections are complaints of stenosis, fistulas, or recurrent diverticular bleeding. Furthermore, an elective sigmoid resection might be justified in high-risk patients, after a conservatively treated episode of diverticulitis, who use immunosuppression therapy and have chronic renal failure or collagen-vascular diseases.

Review of current classifications for diverticular disease and a translation into clinical practice

IntroductionDiverticular disease of the sigmoid colon prevails in Western society. Its presentation may vary greatly per individual patient, from symptomatic diverticulosis to perforated diverticulitis. Since publication of the original Hinchey classification, several modifications and new grading systems have been developed. Yet, new insights in the natural history of the disease, the emergence of the computed tomography scan, and new treatment modalities plead for evolving classifications.MethodsThis article reviews all current classifications for diverticular disease.ResultA three-stage model is advanced for a renewed and comprehensive classification system for diverticular disease, incorporating up-to-date imaging and treatment modalities.

Management of diverticulitis: results of a survey among gastroenterologists and surgeons

Aim  The study aimed to investigate current management strategies for left‐sided diverticulitis and compare them with current international guidelines. Differences between surgeons and gastroenterologists and between gastrointestinal and nongastrointestinal surgeons were assessed.

The cost effectiveness of elective laparoscopic sigmoid resection for symptomatic diverticular disease: financial outcome of the randomized control Sigma trial

BackgroundDirect healthcare costs of patients with symptomatic diverticular disease randomized for either laparoscopic or open elective sigmoid resection are compared. Cost-effectiveness analysis of the laparoscopic approach compared with open sigmoid resections is presented.MethodsAn economic evaluation of the randomized control Sigma trial was conducted, comparing elective laparoscopic sigmoid resection (LSR) to open sigmoid resection (OSR) in patients with symptomatic diverticulitis. Prospective registration of detailed intervention units per patient resulted in actual resource use per individual patient. To avoid distributional assumptions, the nonparametric bootstrap was applied. For the cost-effectiveness analysis, differences in total cost between LSR and OSR were compared with the differences in VAS pain score, SF-36 values for general health, and complication rate.ResultsThe difference in total healthcare costs between the group that received LSR (€ 9969) and the group that received OSR (€ 9366) was not statistically significant. The slight increase in total costs was determined mainly by the significantly higher operation costs of LSR (€ 6663 vs. € 5306). Lower costs for hospitalization (€ 2983 vs. € 3598), blood products (€ 87 vs. € 240), paramedical services (€ 157 vs. € 278), and emergency attendance (€ 72 vs. € 115) in the LSR group partially compensated these increased operation costs. The incremental cost-effectiveness ratios (ICER) indicate that improvements in pain, quality of life, and complication rate could be achieved at limited costs.ConclusionTotal healthcare costs of laparoscopic and open elective sigmoid resections for symptomatic diverticular disease are similar. As the clinical outcomes are in favor of the LSR group, candidates for an elective sigmoid resection should preferably be approached laparoscopically.

Intrathoracic versus Cervical ANastomosis after minimally invasive esophagectomy for esophageal cancer: study protocol of the ICAN randomized controlled trial.

BackgroundCurrently, a cervical esophagogastric anastomosis (CEA) is often performed after minimally invasive esophagectomy (MIE). However, the CEA is associated with a considerable incidence of anastomotic leakage requiring reintervention or reoperation and moderate functional results. An intrathoracic esophagogastric anastomosis (IEA) might reduce the incidence of anastomotic leakage, improve functional results and reduce costs. The objective of the ICAN trial is to compare anastomotic leakage and postoperative morbidity, mortality, quality of life and cost-effectiveness between CEA and IEA after MIE.Methods/designThe ICAN trial is an open randomized controlled multicentre superiority trial, comparing CEA (control group) with IEA (intervention group) after MIE. All patients with esophageal cancer planning to undergo curative MIE are considered for inclusion. A total of 200 patients will be included in the study and randomized between the groups in a 1:1 ratio. The primary outcome is anastomotic leakage requiring reintervention or reoperation, and secondary outcomes are (amongst others) other postoperative complications, new onset of organ failure, length of stay, mortality, benign strictures requiring dilatation, quality of life and cost-effectiveness.DiscussionWe hypothesize that an IEA after MIE is associated with a lower incidence of anastomotic leakage requiring reintervention or reoperation than a CEA. The trial is also designed to give answers to additional research questions regarding a possible difference in functional outcome, quality of life and cost-effectiveness.Trial registrationNetherlands Trial Register: NTR4333. Registered on 23 December 2013.

McKeown or Ivor Lewis totally minimally invasive esophagectomy for cancer of the esophagus and gastroesophageal junction: systematic review and meta-analysis

BACKGROUND Minimally invasive esophagectomy (MIE) has consistently been associated with improved perioperative outcome and similar oncological safety compared to open esophagectomy. However, it is currently unclear what type of MIE is preferred for patients with resectable esophageal cancer. METHODS Literature was searched in Medline, Embase and the Cochrane library combining relevant search terms. Articles that included patients undergoing totally minimally invasive esophagectomy (TMIE) or hybrid minimally invasive esophagectomy (HMIE) and compared McKeown with Ivor Lewis procedures were included. Studies were excluded if they included >10% of patients undergoing a procedure other than MIE McKeown or MIE Ivor Lewis (i.e., transhiatal resections). The primary outcome parameter was anastomotic leakage. Secondary outcome parameters were: other complications, reinterventions, reoperations, hospital length of stay, ICU length of stay, postoperative mortality, operative time, blood loss, R0 resection rate, lymph nodes examined, quality of life and costs. RESULTS Five studies with a total of 1,681 patients undergoing TMIE were included. There were no studies comparing HMIE McKeown versus HMIE Ivor Lewis. There were no randomized controlled trials and all included studies were cohort studies with a moderate risk of bias. No meta-analysis could be performed for R0 resection rate, survival, quality of life and costs because there was insufficient data available for these parameters. The incidence of anastomotic leakage did not differ between the groups [relative risk (RR) =1.39, 95% confidence interval (CI) =0.90-10.38, P=0.14]. TMIE Ivor Lewis was associated with a lower incidence of recurrent laryngeal nerve (RLN) trauma (RR =6.70, 95% CI =3.09-14.55, P<0.001), a shorter hospital length of stay [standardized mean difference (SMD) =0.17, 95% CI =0.06-0.28, P=0.002] and less blood loss (SMD =0.69, 95% CI =0.25-1.12, P=0.002). CONCLUSIONS TMIE Ivor Lewis is associated with improved outcome regarding RLN trauma, hospital length of stay and blood loss as compared to TMIE-McKeown, but the incidence of anastomotic leakage is not different. The evidence is limited, of low quality and at risk for bias. A randomized controlled trial is currently being performed in order to demonstrate whether a McKeown or Ivor Lewis procedure should be preferred in patients undergoing MIE.