Richard C. Thirlby

Perioperative safety in the longitudinal assessment of bariatric surgery.

BACKGROUND To improve decision making in the treatment of extreme obesity, the risks of bariatric surgical procedures require further characterization. METHODS We performed a prospective, multicenter, observational study of 30-day outcomes in consecutive patients undergoing bariatric surgical procedures at 10 clinical sites in the United States from 2005 through 2007. A composite end point of 30-day major adverse outcomes (including death; venous thromboembolism; percutaneous, endoscopic, or operative reintervention; and failure to be discharged from the hospital) was evaluated among patients undergoing first-time bariatric surgery. RESULTS There were 4776 patients who had a first-time bariatric procedure (mean age, 44.5 years; 21.1% men; 10.9% nonwhite; median body-mass index [the weight in kilograms divided by the square of the height in meters], 46.5). More than half had at least two coexisting conditions. A Roux-en-Y gastric bypass was performed in 3412 patients (with 87.2% of the procedures performed laparoscopically), and laparoscopic adjustable gastric banding was performed in 1198 patients; 166 patients underwent other procedures and were not included in the analysis. The 30-day rate of death among patients who underwent a Roux-en-Y gastric bypass or laparoscopic adjustable gastric banding was 0.3%; a total of 4.3% of patients had at least one major adverse outcome. A history of deep-vein thrombosis or pulmonary embolus, a diagnosis of obstructive sleep apnea, and impaired functional status were each independently associated with an increased risk of the composite end point. Extreme values of body-mass index were significantly associated with an increased risk of the composite end point, whereas age, sex, race, ethnic group, and other coexisting conditions were not. CONCLUSIONS The overall risk of death and other adverse outcomes after bariatric surgery was low and varied considerably according to patient characteristics. In helping patients make appropriate choices, short-term safety should be considered in conjunction with both the long-term effects of bariatric surgery and the risks associated with being extremely obese. (ClinicalTrials.gov number, NCT00433810.)

Effects of Perioperative Analgesic Technique on Rate of Recovery after Colon Surgery

Background Choice of perioperative analgesia may affect the rate of recovery of gastrointestinal function and thus duration and cost of hospitalization after colonic surgery.

Weight Change and Health Outcomes at 3 Years After Bariatric Surgery Among Individuals With Severe Obesity

IMPORTANCE Severe obesity (body mass index [BMI] ≥35) is associated with a broad range of health risks. Bariatric surgery induces weight loss and short-term health improvements, but little is known about long-term outcomes of these operations. OBJECTIVE To report 3-year change in weight and select health parameters after common bariatric surgical procedures. DESIGN AND SETTING The Longitudinal Assessment of Bariatric Surgery (LABS) Consortium is a multicenter observational cohort study at 10 US hospitals in 6 geographically diverse clinical centers. PARTICIPANTS AND EXPOSURE: Adults undergoing first-time bariatric surgical procedures as part of routine clinical care by participating surgeons were recruited between 2006 and 2009 and followed up until September 2012. Participants completed research assessments prior to surgery and 6 months, 12 months, and then annually after surgery. MAIN OUTCOMES AND MEASURES Three years after Roux-en-Y gastric bypass (RYGB) or laparoscopic adjustable gastric banding (LAGB), we assessed percent weight change from baseline and the percentage of participants with diabetes achieving hemoglobin A1c levels less than 6.5% or fasting plasma glucose values less than 126 mg/dL without pharmacologic therapy. Dyslipidemia and hypertension resolution at 3 years was also assessed. RESULTS At baseline, participants (N = 2458) were 18 to 78 years old, 79% were women, median BMI was 45.9 (IQR, 41.7-51.5), and median weight was 129 kg (IQR, 115-147). For their first bariatric surgical procedure, 1738 participants underwent RYGB, 610 LAGB, and 110 other procedures. At baseline, 774 (33%) had diabetes, 1252 (63%) dyslipidemia, and 1601 (68%) hypertension. Three years after surgery, median actual weight loss for RYGB participants was 41 kg (IQR, 31-52), corresponding to a percentage of baseline weight lost of 31.5% (IQR, 24.6%-38.4%). For LAGB participants, actual weight loss was 20 kg (IQR, 10-29), corresponding to 15.9% (IQR, 7.9%-23.0%). The majority of weight loss was evident 1 year after surgery for both procedures. Five distinct weight change trajectory groups were identified for each procedure. Among participants who had diabetes at baseline, 216 RYGB participants (67.5%) and 28 LAGB participants (28.6%) experienced partial remission at 3 years. The incidence of diabetes was 0.9% after RYGB and 3.2% after LAGB. Dyslipidemia resolved in 237 RYGB participants (61.9%) and 39 LAGB participants (27.1%); remission of hypertension occurred in 269 RYGB participants (38.2%) and 43 LAGB participants (17.4%). CONCLUSIONS AND RELEVANCE Among participants with severe obesity, there was substantial weight loss 3 years after bariatric surgery, with the majority experiencing maximum weight change during the first year. However, there was variability in the amount and trajectories of weight loss and in diabetes, blood pressure, and lipid outcomes. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00465829.

The role of epidural anesthesia and analgesia in surgical practice.

Objective: To review the potential and proven benefits and complications of epidural anesthesia/analgesia. Summary Background Data: Advances in analgesia/anesthesia have improved patient satisfaction and perioperative outcomes. Epidural anesthesia/analgesia is one of these advances that is gaining rapid acceptance due to a perceived reduction in morbidity and overall patient satisfaction. Methods: A MEDLINE search was conducted for all pertinent articles on epidural anesthesia/analgesia. Results: Retrospective, prospective, and meta-analysis studies have demonstrated an improvement in surgical outcome through beneficial effects on perioperative pulmonary function, blunting the surgical stress response and improved analgesia. In particular, significant reduction in perioperative cardiac morbidity (∼30%), pulmonary infections (∼40%), pulmonary embolism (∼50%), ileus (∼2 days), acute renal failure (∼30%), and blood loss (∼30%) were noted in our review of the literature. Potential complications related to epidural anesthesia/analgesia range from transient paresthesias (<10%) to potentially devastating epidural hematomas (0.0006%). Conclusions: Epidural anesthesia/analgesia has been demonstrated to improve postoperative outcome and attenuate the physiologic response to surgery.

Risk factors and true incidence of pouchitis in patients after ileal pouch-anal anastomoses.

Abstract. Total colectomy, mucosal proctectomy, and ileal J pouch–anal anastomosis (IPAA) has become the procedure of choice for patients with ulcerative colitis and familial adenomatous polyposis. The purpose of this study was to determine the short- and long-term outcomes of patients undergoing IPAA by a single surgeon, correlating intraoperative technical aspects with outcomes, and to characterize better the clinical syndrome of pouchitis. A retrospective review was performed of 114 consecutive patients who underwent IPAA by a single surgeon between December 1987 and August 1996. Clinical follow-up and operative notes were reviewed, and patient questionnaires were obtained for all patients. The mean follow-up was 3 years (range 0.5–8.0 years). The average age of the patients was 39 years (range 16–72 years). There were 64 males and 50 females. Indications for operation were ulcerative colitis (n= 101) and familial polyposis coli (n= 13). Long-term morbidity occurred in 41% of patients (small bowel obstruction 10%, anastomotic stricture 9%). Pouch excision was required in only three patients. Stool frequency (mean ± SE) was 6.1 ± 0.2 and did not change with duration of follow-up. Only 7% of patients reported fecal soilage. The incidence of pouchitis was 59% (n= 67), with 4.2 ± 0.3 episodes of pouchitis per patient. Using multivariate analysis, the factors significantly associated with the incidence of pouchitis were gender (p= 0.008) and duration of follow-up (p= 0.02). A total of 37 of 50 women (74%) but only 30 of 64 men (47%) developed pouchitis. The incidence of pouchitis increased with the duration of follow-up. The incidences of pouchitis in patients followed for 6 months, 1 year, and 3 years were 25%, 37%, and 50%, respectively. Of patients followed more than 6 years, the incidence of pouchitis was 94% (15/16). There was not a significant correlation between anastomotic tension or the extent of arterial dissection of the ileal mesentery required to achieve IPAA and the incidence of pouchitis. The best antibiotics for pouchitis were metronidazole (54% of patients) and ciprofloxacin (37%). Eleven patients have required nearly continuous antibiotics. Patient satisfaction with the outcome is high, with a mean satisfaction of 8.4 (0, dissatisfied; 10, extremely satisfied). This review demonstrates a high incidence of pouchitis in patients after IPAA, which is due to the more liberal definition of the syndrome and the complete follow-up achieved in this report compared to previous series. This study also is unique in identifying the significantly higher incidence of pouchitis in women, although the overall satisfaction with the clinical outcome in patients undergoing IPAA remains high.

Standardized perioperative care protocols and reduced length of stay after colon surgery

BACKGROUND Recent studies have suggested that critical pathways and standard order sets decrease hospital length of stay and improve quality of care. A recently conducted prospective, randomized study at our institution found that patients undergoing elective colon resections had earlier return of bowel function if perioperative epidural anesthesia and analgesia were provided. All patients in the study were also placed on a standardized perioperative regimen. We hypothesized that the standardized perioperative protocol used in this study contributed to early return of bowel function and hospital discharge compared with similar patients managed off protocol. STUDY DESIGN To test this hypothesis, we performed a case-controlled study comparing the hospital courses of 36 study patients to 36 control patients undergoing colorectal surgery by the same surgeons during the same calendar year. The distribution of types of operations and anesthetic techniques was similar in both groups. RESULTS As dictated by the protocol, all study patients had their nasogastric tubes removed, were started on a low fat liquid diet, and ambulated in the first postoperative day. Nasogastric tubes were removed in control patients and study patients 2.2 +/- 0.9 (mean value +/- SD) and 1.0 +/- 0.0 days postoperatively, respectively. Control patients were started on an oral diet, usually clear liquids, an average of 2.9 +/- 1.1 days postoperatively, a specific liquid diet was started 1.0 day postoperatively in study patients (p < 0.001). Return of bowel function, as determined by bowel tones, flatus, and bowel movements, occurred approximately 1 day earlier in study patients. Study patients were discharged 1 day sooner than control patients. CONCLUSIONS Our results suggest that the return of bowel function and the length of stay of patients undergoing colon surgery are improved if patients are entered into a standardized protocol that eliminates variation in intraoperative and postoperative anesthesia and postoperative surgical care. We believe these results can be reproduced in routine clinical surgery by having a clearly outlined protocol for perioperative care similar to that used in this study.

Negative Appendectomy and Imaging Accuracy in the Washington State Surgical Care and Outcomes Assessment Program

Objective:To evaluate negative appendectomy (NA) and the relationship of NA and computed tomography (CT) and/or ultrasound (US). Summary Background Information:NA may be influenced by the use and accuracy of preoperative CT/US. The Surgical Care and Outcomes Assessment Program (SCOAP) gathers chart-abstracted process of care data (such as CT/US accuracy) for general surgical procedures (including appendectomy) at most Washington State hospitals. Methods:We determined the prevalence of NA and CT/US concordance at the 15 SCOAP hospitals with >50 consecutive patients undergoing appendectomy (2006–2007). Results:The number of patients who underwent urgent appendectomies was 3540. The percentage of patients who had imaging (CT-91%) was 86% (women-89%, men-83%). The use of imaging ranged across hospitals from 56% to 97%. There was 91% agreement between imaging and pathology report findings (92.3%-CT and 82.4%-US). The overall rate of NA was 6% (women-8%, men-4%). The prevalence of NA was 9.8% among patients having no imaging, 8.1% among those having an US, and 4.5% in those having a CT. Among patients with NA, CT/US was obtained in 75%; correct in 10% and incorrect or ambiguous in 65%. Higher rates of NA were correlated with lower rates of CT/US concordance (r = −0.57). There was no significant difference in rates of perforation between those with (17%) and without (15%) imaging (P = 0.2). There were significant increases in the use of CT/US and decreases in NA over the time period (P < 0.01). Conclusions:The prevalence of NA at SCOAP hospitals decreased significantly. Variation in NA between hospitals was linked closely to CT/US accuracy suggesting CT/US accuracy should be considered a measure of quality in the care of patients with presumed appendicitis.

Laparoscopy–assisted versus balloon enteroscopy–assisted ERCP in bariatric post–Roux-en-Y gastric bypass patients

BACKGROUND Data on balloon enteroscopy-assisted ERCP (BEA-ERCP) versus laparoscopy-assisted ERCP (LA-ERCP) in post-Roux-en-Y gastric bypass (RYGB) patients are lacking. OBJECTIVES To compare BEA-ERCP with LA-ERCP in post-RYGB patients and to identify factors that predict therapeutic success with BEA-ERCP. DESIGN Retrospective chart review. SETTING A single North American tertiary referral center. PATIENTS The review included 56 bariatric post-RYGB patients who underwent ERCP. INTERVENTIONS BEA-ERCP or LA-ERCP. MAIN OUTCOME MEASUREMENTS Cannulation rate, therapeutic success, hospital stay, complications, procedure duration, endoscopist time, and cost. RESULTS A total of 32 patients underwent BEA-ERCP, and 24 underwent LA-ERCP. LA-ERCP was superior to BEA-ERCP in papilla identification (100% vs 72%, P = .005), cannulation rate (100% vs 59%, P < .001), and therapeutic success (100% vs 59%, P < .001). The total procedure time was shorter (P < .001) and endoscopist time was longer (P = .006) for BEA-ERCP. There was no difference in postprocedure hospital stay (P = .127) or complication rate (P = .392) between the 2 groups. In the BEA-ERCP group, in patients having a Roux limb + biliopancreatic (from ligament of Treitz to jejunojejunal anastomosis), a limb length less than 150 cm was associated with therapeutic success. Starting with BEA-ERCP and continuing with LA-ERCP after a failed BEA-ERCP saved

Prevention of postoperative abdominal adhesions by a novel, glycerol/sodium hyaluronate/carboxymethylcellulose-based bioresorbable membrane: A prospective, randomized, evaluator-blinded multicenter study

1015 compared with starting with LA-ERCP. LIMITATIONS Single center, retrospective study. CONCLUSIONS In centers with expertise in deep enteroscopy and ERCP, post-RYGB patients with a Roux + ligament of Treitz to jejunojejunal anastomosis limb length less than 150 cm should first be offered deep enteroscopy-assisted ERCP. In patients with Roux + ligament of Treitz to jejunojejunal anastomosis (LTJJ) limb length 150 cm or longer, LA-ERCP should be the preferred approach because of the lack of need for a second procedure, equivalent morbidity and hospital stay, decreased endoscopist time, and decreased cost.

What symptoms does cholecystectomy cure ? Insights from an outcomes measurement project and review of the literature

INTRODUCTIONPostoperative abdominal adhesions are associated with significant morbidity and mortality, placing a substantial burden on healthcare systems worldwide. Development of a bioresorbable membrane containing up to 23 percent glycerol and chemically modified sodium hyaluronate/carboxymethylcellulose offers ease of handling and has been shown to provide significant postoperative adhesion prevention in animals. This study was designed to assess the safety of glycerol hyaluronate/carboxymethylcellulose and to evaluate its efficacy in reducing the incidence, extent, and severity of postoperative adhesion development in surgical patients.METHODSTwelve centers enrolled 120 patients with ulcerative colitis or familial polyposis who were scheduled for a restorative proctocolectomy and ileal pouch-anal anastomosis with diverting loop ileostomy. Before surgical closure, patients were randomized to no antiadhesion treatment (control) or treatment with glycerol hyaluronate/carboxymethylcellulose membrane under the midline incision. At ileostomy closure, laparoscopy was used to evaluate the incidence, extent, and severity of adhesion formation to the midline incision.RESULTSData were analyzed using the intent-to-treat population. Treatment with glycerol hyaluronate/carboxymethylcellulose resulted in 19 of 58 patients (33 percent) with no adhesions compared with 6 of 60 adhesion-free patients (10 percent) in the no treatment control group (P = 0.002). The mean extent of postoperative adhesions to the midline incision was significantly lower among patients treated with glycerol hyaluronate/carboxymethylcellulose compared with patients in the control group (P < 0.001). The severity of postoperative adhesions to the midline incision was significantly less with glycerol hyaluronate/carboxymethylcellulose than with control (P < 0.001). Adverse events were similar between treatment and no treatment control groups with the exception of abscess and incisional wound complications were more frequently observed with glycerol hyaluronate/carboxymethylcellulose.CONCLUSIONSGlycerol hyaluronate/carboxymethylcellulose was shown to effectively reduce adhesions to the midline incision and adhesions between the omentum and small bowel after abdominal surgery. Safety profiles for the treatment and no treatment control groups were similar with the exception of more infection complications associated with glycerol hyaluronate/carboxymethylcellulose use. Animal models did not predict these complications.