Tero Rautio

Antibiotic Therapy vs Appendectomy for Treatment of Uncomplicated Acute Appendicitis: The APPAC Randomized Clinical Trial

IMPORTANCE An increasing amount of evidence supports the use of antibiotics instead of surgery for treating patients with uncomplicated acute appendicitis. OBJECTIVE To compare antibiotic therapy with appendectomy in the treatment of uncomplicated acute appendicitis confirmed by computed tomography (CT). DESIGN, SETTING, AND PARTICIPANTS The Appendicitis Acuta (APPAC) multicenter, open-label, noninferiority randomized clinical trial was conducted from November 2009 until June 2012 in Finland. The trial enrolled 530 patients aged 18 to 60 years with uncomplicated acute appendicitis confirmed by a CT scan. Patients were randomly assigned to early appendectomy or antibiotic treatment with a 1-year follow-up period. INTERVENTIONS Patients randomized to antibiotic therapy received intravenous ertapenem (1 g/d) for 3 days followed by 7 days of oral levofloxacin (500 mg once daily) and metronidazole (500 mg 3 times per day). Patients randomized to the surgical treatment group were assigned to undergo standard open appendectomy. MAIN OUTCOMES AND MEASURES The primary end point for the surgical intervention was the successful completion of an appendectomy. The primary end point for antibiotic-treated patients was discharge from the hospital without the need for surgery and no recurrent appendicitis during a 1-year follow-up period. RESULTS There were 273 patients in the surgical group and 257 in the antibiotic group. Of 273 patients in the surgical group, all but 1 underwent successful appendectomy, resulting in a success rate of 99.6% (95% CI, 98.0% to 100.0%). In the antibiotic group, 70 patients (27.3%; 95% CI, 22.0% to 33.2%) underwent appendectomy within 1 year of initial presentation for appendicitis. Of the 256 patients available for follow-up in the antibiotic group, 186 (72.7%; 95% CI, 66.8% to 78.0%) did not require surgery. The intention-to-treat analysis yielded a difference in treatment efficacy between groups of -27.0% (95% CI, -31.6% to ∞) (P = .89). Given the prespecified noninferiority margin of 24%, we were unable to demonstrate noninferiority of antibiotic treatment relative to surgery. Of the 70 patients randomized to antibiotic treatment who subsequently underwent appendectomy, 58 (82.9%; 95% CI, 72.0% to 90.8%) had uncomplicated appendicitis, 7 (10.0%; 95% CI, 4.1% to 19.5%) had complicated acute appendicitis, and 5 (7.1%; 95% CI, 2.4% to 15.9%) did not have appendicitis but received appendectomy for suspected recurrence. There were no intra-abdominal abscesses or other major complications associated with delayed appendectomy in patients randomized to antibiotic treatment. CONCLUSIONS AND RELEVANCE Among patients with CT-proven, uncomplicated appendicitis, antibiotic treatment did not meet the prespecified criterion for noninferiority compared with appendectomy. Most patients randomized to antibiotic treatment for uncomplicated appendicitis did not require appendectomy during the 1-year follow-up period, and those who required appendectomy did not experience significant complications. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01022567.

Effect of Robotic-Assisted vs Conventional Laparoscopic Surgery on Risk of Conversion to Open Laparotomy Among Patients Undergoing Resection for Rectal Cancer: The ROLARR Randomized Clinical Trial

Importance Robotic rectal cancer surgery is gaining popularity, but limited data are available regarding safety and efficacy. Objective To compare robotic-assisted vs conventional laparoscopic surgery for risk of conversion to open laparotomy among patients undergoing resection for rectal cancer. Design, Setting, and Participants Randomized clinical trial comparing robotic-assisted vs conventional laparoscopic surgery among 471 patients with rectal adenocarcinoma suitable for curative resection conducted at 29 sites across 10 countries, including 40 surgeons. Recruitment of patients was from January 7, 2011, to September 30, 2014, follow-up was conducted at 30 days and 6 months, and final follow-up was on June 16, 2015. Interventions Patients were randomized to robotic-assisted (n = 237) or conventional (n = 234) laparoscopic rectal cancer resection, performed by either high (upper rectum) or low (total rectum) anterior resection or abdominoperineal resection (rectum and perineum). Main Outcomes and Measures The primary outcome was conversion to open laparotomy. Secondary end points included intraoperative and postoperative complications, circumferential resection margin positivity (CRM+) and other pathological outcomes, quality of life (36-Item Short Form Survey and 20-item Multidimensional Fatigue Inventory), bladder and sexual dysfunction (International Prostate Symptom Score, International Index of Erectile Function, and Female Sexual Function Index), and oncological outcomes. Results Among 471 randomized patients (mean [SD] age, 64.9 [11.0] years; 320 [67.9%] men), 466 (98.9%) completed the study. The overall rate of conversion to open laparotomy was 10.1%: 19 of 236 patients (8.1%) in the robotic-assisted laparoscopic group and 28 of 230 patients (12.2%) in the conventional laparoscopic group (unadjusted risk difference = 4.1% [95% CI, −1.4% to 9.6%]; adjusted odds ratio = 0.61 [95% CI, 0.31 to 1.21]; P = .16). The overall CRM+ rate was 5.7%; CRM+ occurred in 14 (6.3%) of 224 patients in the conventional laparoscopic group and 12 (5.1%) of 235 patients in the robotic-assisted laparoscopic group (unadjusted risk difference = 1.1% [95% CI, −3.1% to 5.4%]; adjusted odds ratio = 0.78 [95% CI, 0.35 to 1.76]; P = .56). Of the other 8 reported prespecified secondary end points, including intraoperative complications, postoperative complications, plane of surgery, 30-day mortality, bladder dysfunction, and sexual dysfunction, none showed a statistically significant difference between groups. Conclusions and Relevance Among patients with rectal adenocarcinoma suitable for curative resection, robotic-assisted laparoscopic surgery, as compared with conventional laparoscopic surgery, did not significantly reduce the risk of conversion to open laparotomy. These findings suggest that robotic-assisted laparoscopic surgery, when performed by surgeons with varying experience with robotic surgery, does not confer an advantage in rectal cancer resection. Trial Registration isrctn.org Identifier: ISRCTN80500123

Endovenous Obliteration with Radiofrequency-resistive Heating for Greater Saphenous Vein Insufficiency: A Feasibility Study

PURPOSE To assess the feasibility, safety, and clinical utility of ultrasound (US)- and fluoroscopy-guided endovenous saphenous vein obliteration with radiofrequency (RF)-resistive heating in the treatment of primary venous insufficiency. MATERIALS AND METHODS Thirty legs of 27 patients with mild to moderate varicose veins and primary greater saphenous vein (GSV) insufficiency diagnosed with duplex US were treated. An endovenous catheter was inserted via US-guided percutaneous puncture or a skin incision. Fluoroscopy and US were used to locate the electrodes at the saphenofemoral junction. GSVs were occluded with RF-resistive heating. Local phlebectomies or sclerotherapy were performed in all procedures to treat varicose veins and teleangiectases. Persistence of vein occlusion and complications potentially attributable to endovenous treatment were assessed at 1 week, 6 weeks, 3 months, 6 months, and 1 year. RESULTS The mean follow-up time was 9.6 months (SD, 3.8 mo). By the time of the last follow-up visit, occlusion of the treated segment of the GSV had been achieved in 22 legs (73.3%). Persisting patency or recanalization of the GSV was detected in eight legs (26.7%). One patient (3.3%) had varicosity-related symptoms, and three treated legs (10%) had recurrent or new varicosities. Postoperative complications included saphenous nerve paresthesia in three legs (10%) and thermal skin injury in one limb (3.3%). CONCLUSION Endovenous obliteration employing RF-resistive heating is a relatively safe and promising minimally invasive technique for the treatment of primary GSV insufficiency.

Prospective, Randomized Study on the Use of a Prosthetic Mesh for Prevention of Parastomal Hernia of Permanent Colostomy.

BACKGROUND: Prophylactic placement of a mesh has been suggested to prevent parastomal hernia, but evidence to support this approach is scarce. OBJECTIVE: The aim of this study was to evaluate whether laparoscopic placement of a prophylactic, dual-component, intraperitoneal onlay mesh around a colostomy is safe and prevents parastomal hernia formation after laparoscopic abdominoperineal resection. DESIGN: This is a prospective, multicenter, randomized controlled clinical trial. SETTINGS: This study was conducted at 2 university and 3 central Finnish hospitals. PATIENTS: From 2010 to 2013, 83 patients undergoing laparoscopic abdominoperineal resection for rectal cancer were recruited. After withdrawals and exclusions, the outcome of 70 patients, 35 patients in each study group, could be examined. INTERVENTIONS: In the intervention group, an end colostomy was created with placement of a intraperitoneal, dual-component onlay mesh and compared with a group with a traditional stoma. MAIN OUTCOME MEASURES: The main outcome measures were the incidence of clinically and radiologically detected parastomal hernias and their extent 12 months after surgery. Stoma-related morbidity and the need for surgical repair of parastomal hernia were secondary outcome measures. RESULTS: Parastomal hernia was observed by clinical inspection in 5 intervention patients (14.3%) and in 12 control patients (32.3%; p = 0.049). Surgical repair of parastomal hernia was performed in 1 control patient (3.2%) and in none of the patients in the intervention group. CT detected parastomal hernia in 18 intervention patients (51.4%) and in 17 control patients (53.1%; p = 1.00). The extent of hernias was similar according to European Hernia Society classification (p = 0.41). Colostomy-related morbidity (32.3% vs 14.3%; p = 0.140) did not differ between the study groups. LIMITATIONS: The study was limited by its small size and short follow-up time. CONCLUSIONS: Prophylactic laparoscopic placement of intraperitoneal onlay mesh does not significantly reduce the overall risk of radiologically detected parastomal hernia after laparoscopic abdominoperineal resection. However, prophylactic mesh repair was associated with significantly lower risk of clinically detected parastomal hernia.

A prospective randomized controlled multicenter trial comparing antibiotic therapy with appendectomy in the treatment of uncomplicated acute appendicitis (APPAC trial).

BackgroundAlthough the standard treatment of acute appendicitis (AA) consists of an early appendectomy, there has recently been both an interest and an increase in the use of antibiotic therapy as the primary treatment for uncomplicated AA. However, the use of antibiotic therapy in the treatment of uncomplicated AA is still controversial.Methods/designThe APPAC trial is a randomized prospective controlled, open label, non-inferiority multicenter trial designed to compare antibiotic therapy (ertapenem) with emergency appendectomy in the treatment of uncomplicated AA. The primary endpoint of the study is the success of the randomized treatment. In the antibiotic treatment arm successful treatment is defined as being discharged from the hospital without the need for surgical intervention and no recurrent appendicitis during a minimum follow-up of one-year (treatment efficacy). Treatment efficacy in the operative treatment arm is defined as successful appendectomy evaluated to be 100%. Secondary endpoints are post-intervention complications, overall morbidity and mortality, the length of hospital stay and sick leave, treatment costs and pain scores (VAS, visual analoque scale). A maximum of 610 adult patients (aged 18–60 years) with a CT scan confirmed uncomplicated AA will be enrolled from six hospitals and randomized by a closed envelope method in a 1:1 ratio either to undergo emergency appendectomy or to receive ertapenem (1 g per day) for three days continued by oral levofloxacin (500 mg per day) plus metronidazole (1.5 g per day) for seven days. Follow-up by a telephone interview will be at 1 week, 2 months and 1, 3, 5 and 10 years; the primary and secondary endpoints of the trial will be evaluated at each time point.DiscussionThe APPAC trial aims to provide level I evidence to support the hypothesis that approximately 75–85% of patients with uncomplicated AA can be treated with effective antibiotic therapy avoiding unnecessary appendectomies and the related operative morbidity, also resulting in major cost savings.Trial registrationClinicaltrials.govhttp://NCT01022567

Robot‐assisted vs laparoscopic ventral rectopexy for external or internal rectal prolapse and enterocele: a randomized controlled trial

The purpose of this prospective randomized study was to compare robot‐assisted and laparoscopic ventral rectopexy procedures for posterior compartment procidentia in terms of restoration of the anatomy using magnetic resonance (MR) defaecography.

The role of C-reactive protein in prediction of the severity of acute diverticulitis in an emergency unit.

Abstract Objective. Computed tomography (CT) is the most appropriate initial imaging modality for the assessment of acute diverticulitis. The aim here was to determine the usefulness of C-reactive protein (CRP) in predicting the severity of the diverticulitis process and the need for a CT examination. Methods. The CRP values of 350 patients who presented first time with symptoms of acute diverticulitis and underwent CT imaging on admission to Oulu University Hospital were compared with the CT findings and clinical parameters by means of both univariate and multivariate analyses. Results. The receiver operating characteristic curve showed that a CRP cut-off value of 149.5 mg/l significantly discriminated acute uncomplicated diverticulitis from complicated diverticulitis (specificity 65%, sensitivity 85%, area under the curve 0.811, p = 0.0001). In multivariate analysis, a CRP value over 150 mg/l and old age were independent risk factors for acute complicated diverticulitis. The mean CRP value was significantly higher in the patients who died, 207 (84 SD), than in those who survived, 139 (SD 83). In addition, a CRP value over 150 mg/l and free abdominal fluid in CT were independent variables predicting postoperative mortality. Conclusions. CRP is useful for the predicting the severity of acute diverticulitis on admission. Patients with a CRP value higher than 150 mg/l have an in increased risk of complicated diverticulitis and a CT examination should always be carried out.

Economic evaluation of antibiotic therapy versus appendicectomy for the treatment of uncomplicated acute appendicitis from the APPAC randomized clinical trial

An increasing amount of evidence supports antibiotic therapy for treating uncomplicated acute appendicitis. The objective of this study was to compare the costs of antibiotics alone versus appendicectomy in treating uncomplicated acute appendicitis within the randomized controlled APPAC (APPendicitis ACuta) trial.

Laparoscopic versus Hybrid Approach for Treatment of Incisional Ventral Hernia

Background: The aim of this study was to compare the efficacy of a hybrid approach (HA) versus laparoscopy in reducing the risk of complications related to complex adhesiolysis in incisional ventral hernia repair (IVHR). Methods: This study included 269 adult patients who underwent laparoscopic IVHR at the Oulu University Hospital, Finland during 2006-2012. Baseline, operative and postoperative data was collected and compared between the treatment groups; that is, a comparison was made between the laparoscopic approach (LA, 38 patients) and the hybrid approach (HA, 24 patients). Results: In the LA group, 11 (28.9%) patients experienced postoperative complications. There were 4 undetected enterotomies that led to major complications, reoperations and one death. In the HA group, 6 (25%) patients experienced mild and moderate complications. During adhesiolysis, 4 enterotomies occurred but were immediately sutured without any complication. Conclusion: Adhesiolysis through a minimally invasive open technique may be associated with a lower risk of undetected enterotomy in patients with complex adhesions. In IVHR, the hybrid should be considered the operative method of choice when adhesions are foreseeable.

The quality of life of gastroesophageal reflux disease patients waiting for an antireflux operation

BackgroundThe purpose of this trial was to measure the health-related quality of life (HRQL) of gastroesophageal reflux disease (GERD) patients waiting for an antireflux operation.MethodsA total of 120 patients waiting for a laparoscopic fundoplication were sent questionnaires measuring their symptoms and quality of life.ResultsNinety-five of the patients still needing an operation returned the questionaires and were included in the analysis. Thirty-one of 84 patients (37%) felt that the symptoms had worsened, and 51/90 (57%) were unsatisfied. Thirty percent suffered from throat or airway infections, 25% from swallowing difficulties, 48% from retrosternal pain, and 18% had asthma. The mean GERD HRQL score (0–45) was 21.7 (95% confidence interval, 19.7–23.7). Short Form-36 scores of this population were significantly worse when compared to patients with inguinal hernia or moderate asthma.ConclusionsPatients waiting for a fundoplication seem to have a significantly decreased health-related quality of life due to poor symptom control regardless of continuous medical treatment.