Postoperative complications are not increased in super-super obese patients who undergo laparoscopic Roux-en-Y gastric bypass.

BACKGROUND: It has been suggested that super-super obesity (body mass index [BMI] > or =60 kg/m2) increases the risk of complications after laparoscopic Roux-en-Y gastric bypass (LapRYGB). We hypothesized that a higher BMI does not increase risk the morbidity or mortality rate. METHODS: Complication rates for patients with a BMI > or =60 kg/m2 were compared to those for patients with a BMI <60 kg/m2 who underwent LapRYGB during the same time period. Differences between the groups were analyzed by Fisher's exact test, t-tests, and analysis of variance. RESULTS: Forty-five patients with a BMI > or =60 kg/m2 and 640 patients with a BMI <60 kg/m2 underwent LapRYGB. There were no statistically significant differences between the two groups in the complication or mortality rates. Excess weight loss was less, but actual weight lost was greater in the BMI > or =60 kg/m2 group. CONCLUSIONS: The complication and mortality rates are not increased in super-super obese patients who undergo LapRYGB. Acceptable weight loss can be achieved safely in these patients.

Evidence-based medicine reports on obesity surgery: a critique.

OBJECTIVE: To evaluate evidence in recent authoritative 'Evidence-Based Medicine' (EBM) reports on surgery for severe obesity. METHODS: Focused review of Index Medicus citations and authors' own databases of publications on surgery for obesity, 1978-2004. RESULTS: EBM criteria for assessment of strength of evidence requiring randomized controlled studies (RCTs) in these reports are inappropriate for evaluating invasive treatments such as surgery, which have robust physiological effects, are difficult to reverse and may have more serious side effects than the drug studies for which the criteria were promulgated. Flaws in these reports include omissions of important studies demonstrating improvements in comorbidity, factual errors in descriptions of operations and faulty analyses of outcomes of laparoscopic approaches. There are misinterpretations of cited papers, and inclusion of obsolete operations as well as a study generated during the 'learning curve' of an avowed complex procedure. CONCLUSION: EBM analyses of surgical modalities affecting access to care require relevant evaluation criteria, true peer review and expert consultation. Authors' claims of objectivity by invoking use of evidence-based criteria applicable to drug treatment and other easily reversible forms of therapy are questionable. Decisions based on flawed EBM reports may adversely affect access to care for millions of severely obese patients.

Experience with over 3,000 open and laparoscopic bariatric procedures: multivariate analysis of factors related to leak and resultant mortality.

BACKGROUND: Intestinal leak is a potentially lethal complication of Roux en-Y gastric bypass (GBP). Identification of patients at high risk for leak may reduce complication rates of surgeons early in the procedure learning curve. METHODS: A total of 3073 patients who underwent GBP were analyzed using univariate and multivariate logistic regression analyses of the following preoperative factors: hypertension (HTN), diabetes mellitus (DM), sleep apnea (SA), age, gender, weight, body mass index (BMI), and surgery type. Multivariate logistic regression analysis was performed for each procedure type. RESULTS: There were 48 (1.5%) deaths. Independent risk factors for death included leak, weight, procedure type, and HTN. A total of 102 (3.2%) leaks were found. Independent factors for leak included age, male gender, SA, and procedure type. CONCLUSION: The data suggests that older, heavier male patients with multiple comorbid conditions are at increased risk for leak and mortality. Surgeons early in their learning curve should avoid these high-risk patients to reduce complications.

Hand-assisted laparoscopic gastric bypass does not improve outcome and increases costs when compared to open gastric bypass for the surgical treatment of obesity.

BACKGROUND: Hand-assisted laparoscopic Roux-en-Y gastric bypass (Hand-Lap GB) has been adopted by some surgeons to treat morbid obesity because it is easier to perform than the total laparoscopic procedure, but to date no study has compared the outcomes of patients undergoing the Hand-Lap GB to those obtained with the open procedure (Open GB). We hypothesized that patients undergoing Hand-Lap GB would lose a similar amount of weight when compared to Open GB patients, while experiencing no increase in complications, a shorter hospital stay, and lower overall costs of care, in part as a result of fewer incisional hernias requiring subsequent surgery. METHODS: Nonrandomized, prospective data were collected on all patients undergoing proximal GB via Hand-Lap or open approaches between May 1998 and July 1999. Our first 25 Hand-Lap GB procedures, performed in selected patients (with no extensive previous abdominal surgery) referred to two of us (E.J.D, M.A.S), were compared to all other (n = 62) concurrent open proximal GB performed by the group during this period of time in patients with body mass index (BMI) <50 kg/m2. RESULTS: Preoperatively, Hand-Lap GB patients did not differ from Open GB patients in age (40 +/- 11 vs 43 +/- 11 years), gender (92% female vs 81% female), incidence or type of preoperative comorbid conditions, preoperative weight (282 +/- 33 vs 280 +/- 37 lb), or BMI (45.5 +/- 5.4 vs 44.1 +/- 3.3 kg/m2). (Data given as mean +/- standard deviation). Although length of hospital stay did not differ between groups (3.6 +/- 1.3 vs 4.2 +/- 4.6 days), total hospital costs were significantly higher for Hand-Lap GB ($14,725 +/- 3089 vs. $10,281 +/- 3687, p <0.01 ANOVA). One patient in the Open GB group developed an anastomotic leak from the gastrojejunostomy. Follow-up revealed that Hand-Lap GB patients had a similar risk of postoperative complications as the Open GB group, including marginal ulcer (16% vs 14.5%), stomal stenosis (24% vs 23%), and, most notably, incisional hernia (20% vs 27%). There were no major wound infections or deaths in either group. One patient in each group developed a postoperative small bowel obstruction. Loss of excess weight in Hand-Lap GB patients at 12 months postoperatively was 66 +/- 14% vs 77 +/- 14% in the Open GB group. CONCLUSIONS: The Hand-Lap GB yielded good weight reduction in a population of morbidly obese patients, but at a higher cost for hospital care than Open GB. There was no decrease in the incidence of incisional hernias with the Hand-Lap GB procedure. Although Hand-Lap GB appears to be safe and effective, its failure to provide a decrease in hospital stay or risk of incisional hernia requiring subsequent surgical repair is significant. The primary role for the Hand-Lap GB procedure should therefore be to aid surgeons in developing skills to climb the steep learning curve for total laparoscopic gastric bypass, since Hand-Lap GB does not improve patient outcome and increases cost in comparison to the open GB procedure.

Effects of increased intra-abdominal pressure in severe obesity.

This article gives an overview, citing animal and clinical studies, of the effects of increased intra-abdominal pressure (IAP) in severe obesity. Animal studies demonstrate that increased IAP increases pleural pressure, cardiac filling pressures, femoral venous pressure, renal venous pressure, systemic blood pressure, and vascular resistance, renin and aldosterone levels, and intracranial pressure. Thus, the comorbidities presumed secondary to increased IAP in obese patients include congestive heart failure, hypoventilation, venous stasis ulcers, gastroesophageal reflux, urinary stress incontinence, incisional hernia, pseudotumor cerebri, proteinuria, and systemic hypertension.

Risks and benefits of gastric bypass in morbidly obese patients with severe venous stasis disease.

OBJECTIVE: To determine the risks and benefits of gastric bypass-induced weight loss on severe venous stasis disease in morbid obesity. SUMMARY BACKGROUND DATA: Severe obesity is associated with a risk of lower extremity venous stasis disease, pretibial ulceration, cellulitis, and bronze edema. METHODS: The GBP database was queried for venous stasis disease including pretibial venous stasis ulcers, bronze edema, and cellulitis. RESULTS: Of 1,976 patients undergoing GBP, 64 (45% female) met the criteria. Mean age was 44 +/- 10 years. Thirty-seven patients had pretibial venous stasis ulcers, 4 had bronze edema, 23 had both, and 17 had recurrent cellulitis. All had 2 to 4+ pitting pretibial edema. Mean preoperative body mass index (BMI) was 61 +/- 12 kg/m(2) and weight was 179 +/- 39 kg (270 +/- 51% ideal body weight), significantly greater than in patients who underwent GBP without venous stasis disease. Two patients had a pulmonary embolus and four had Greenfield filters in the remote past. Additional comorbidities included obesity hypoventilation syndrome, sleep apnea syndrome, hypertension, gastroesophageal reflux, degenerative joint disease symptoms, type 2 diabetes mellitus, pseudotumor cerebri, and urinary incontinence. Comorbidities were significantly more frequent in the patients with venous stasis disease than for those without. At 3.9 +/- 4 years after surgery, patients lost 55 +/- 21 % of excess weight, 62 +/- 33 kg, reaching 40 +/- 9 kg/m(2) BMI or 176 +/- 41% ideal body weight. Venous stasis ulcers resolved in all but three patients. Complications included anastomotic leaks with peritonitis and death, fatal pulmonary embolism, fatal respiratory arrest, wound infections or seromas, staple line disruptions, marginal ulcerations treated with acid suppression, stomal stenoses treated with endoscopic dilatation, late small bowel obstructions, and incisional hernias. There were six other late deaths. CONCLUSIONS: Severe venous stasis disease was associated with a significantly greater weight, BMI, male sex, age, comorbidity, and surgical risk (pulmonary embolus, leak, death, incisional hernia) than in other patients who underwent GBP. Surgically induced weight loss corrected the venous stasis disease in almost all patients as well as their other obesity-related problems.

High failure rate after laparoscopic adjustable silicone gastric banding for treatment of morbid obesity.

OBJECTIVE: To report the results from one of the eight original U.S. centers performing laparoscopic adjustable silicone gastric banding (LASGB), a new minimally invasive surgical technique for treatment of morbid obesity. SUMMARY BACKGROUND DATA: Laparoscopic adjustable silicone gastric banding is under evaluation by the Food & Drug Administration in the United States in an initial cohort of 300 patients. METHODS: Of 37 patients undergoing laparoscopic placement of the LASGB device, successful placement occurred in 36 from March 1996 to May 1998. Patients have been followed up for up to 4 years. RESULTS: Five patients (14%) have been lost to follow-up for more than 2 years but at last available follow-up (3-18 months after surgery) had achieved only 18% (range 5-38%) excess weight loss. African American patients had poor weight loss after LASGB compared with whites. The LASGB devices were removed in 15 (41%) patients 10 days to 42 months after surgery. Four patients underwent simple removal; 11 were converted to gastric bypass. The most common reason for removal was inadequate weight loss in the presence of a functioning band. The primary reasons for removal in others were infection, leakage from the inflatable silicone ring causing inadequate weight loss, or band slippage. The patients with band slippage had concomitant poor weight loss. Bands were removed in two others as a result of symptoms related to esophageal dilatation. In 18 of 25 patients (71%) who underwent preoperative and long-term postoperative contrast evaluation, a significantly increased esophageal diameter developed; of these, 13 (72%) had prominent dysphagia, vomiting, or reflux symptoms. Of the remaining 21 patients with bands, 8 currently desire removal and conversion to gastric bypass for inadequate weight loss. Six of the remaining patients have persistent morbid obesity at least 2 years after surgery but refuse to undergo further surgery or claim to be satisfied with the results. Overall, only four patients achieved a body-mass index of less than 35 and/or at least a 50% reduction in excess weight. Thus, the overall need for band removal and conversion to GBP in this series will ultimately exceed 50%. CONCLUSIONS: The authors did not find LASGB to be an effective procedure for the surgical treatment of morbid obesity. Complications after LASGB include esophageal dilatation, band leakage, infection, erosion, and slippage. Inadequate weight loss is common, particularly in African American patients. More study is required to determine the long-term efficacy of the LASGB

Continuous negative abdominal pressure device to treat pseudotumor cerebri.

OBJECTIVE: To study the effects of an externally applied negative abdominal pressure device designed to lower the effects of intra-abdominal pressure (IAP) on headaches and pulsatile tinnitus in severely obese women with pseudotumor cerebri (PTC). DESIGN: Short-term clinical intervention trial in the Clinical Research Center. Days 1 and 3 were 'control' days; on days 2 and 4-6 patients were in the device from 8:00 am to noon and from 1:00 to 5:00 pm, and on nights 7-11 they were in the device from 10:00 pm to 8:00 am. The last four patients were treated in a device with a counter-traction mechanism. SUBJECTS: Seven centrally obese women with PTC. MEASUREMENTS: Headache and pulsatile tinnitus severity were graded by the patient using visual analog scale (1-10) and averaged for the time that the device was in use or not in use. IAP was estimated from urinary bladder pressure (UBP) before and during device use. The internal jugular vein (IJV) elliptical cross-sectional area was measured with B-mode ultrasonography; the timed average velocity was measured by Doppler. RESULTS: There was a decrease in both headache (6.8+/-0.8 to 4.2+/-0.8, P<0.05) and pulsatile tinnitus (4.2+/-0.5 to 1.8+/-0.5, P<0.02) within 5 min, and in headache (to 2.2+/-0.8, P<0.01) and tinnitus (to 1.7+/-0.5, P<0.01) within 1 h of device activation. UBP decreased (P<0.001) from 19.1+/-3 to 12.5+/-2.8 cmH2O. Headache remained improved throughout time that the device was used. During the second week, five of seven patients slept in the device without difficulty and four awoke without headache. There was a progressive decrease (P<0.01) in headache during the day after sleeping in the device at night as compared with days 1 and 3 when it was not used (6.5+/-0.5, day 1; 4.1+/-0.7, day 3; 3.1+/-0.8, day 8; 2.3+/-0.8, day 10). Headaches returned late in the afternoon in two patients; the device was reactivated and headache again improved. Five patients underwent IJV sonography; the IJV area decreased (129+/-53 to 100+/-44 mm2, P=0.06) without a change in IJV flow (1004+/-802 to 1000+/-589 ml/min) with the device. When activated, the device was pulled into the patient, creating discomfort that was alleviated with the counter-traction mechanism in the last four patients. One patient developed a 5 cm area of blisters that resolved when the device was worn over a hospital gown. CONCLUSIONS: Decreasing IAP relieved headaches and pulsatile tinnitus in PTC. When patients slept in the device, they awoke without headache or tinnitus, which remained markedly improved throughout most of the following day. This study supports the hypothesis that PTC in obese women is secondary to an increased IAP.

Bariatric surgery for severe obesity.

Severe obesity is associated with multiple comorbidities and is refractory to dietary management with or without behavioral or drug therapies. There are a number of surgical procedures for the treatment of morbid obesity, including purely gastric restrictive, a combination of malabsorption and gastric restriction or primary malabsorption. The purely gastric restrictive procedures, including vertical banded gastroplasty and laparoscopic adjustable silicone gastric banding, do not provide adequate weight loss. African-American patients do especially poorly after the banding procedure with the loss of only 11% of excess weight in one study. Gastric bypass (GBP) is associated with the loss of 66% of excess weight at 1 to 2 years after surgery, 60% at 5 years and 50% at 10 years. For unknown reasons, African-American patients lose significantly less weight than Caucasians after GBP. There is a risk of micronutrient deficiencies after GBP, including iron deficiency anemia in menstruating women, vitamin B12, and calcium deficiencies. Prophylactic supplementation of these nutrients is necessary. Recurrent vomiting after bariatric surgery may be associated with a severe polyneuropathy and must be aggressively treated with endoscopic dilatation before this complication is allowed to develop. The malabsorptive procedures include the partial biliopancreatic bypass (BPD) and BPD with duodenal switch (BPD/DS). The BPD appears to cause severe protein-calorie malnutrition in American patients; the BPD/DS may be associated with less malnutrition. Weight loss failure after GBP does not respond to tightening a dilated gastrojejunal stoma or reducing the size of the gastric pouch. These patients may require conversion to a malabsorptive distal GBP, similar to the BPD. However, because of the risk of severe protein-calorie malnutrition and calcium deficiency BPD should be reserved for patients with severe obesity comorbidity. The risk of death following bariatric surgery is between 1% and 2% in most series but is significantly higher in patients with respiratory insufficiency of obesity. In most patients, surgically induced weight loss will correct hypertension, type II diabetes mellitus, sleep apnea, obesity hypoventilation syndrome, gastroesophageal reflux, venous stasis disease, urinary incontinence, female sexual hormone dysfunction, pseudotumor cerebri, degenerative joint disease pains, as well as improved self-image and employability.

Pulsatile tinnitus in patients with morbid obesity: the effectiveness of weight reduction surgery.

BACKGROUND: Morbid obesity is increasing in the United States population. Morbidly obese patients may have disabling pulsatile tinnitus (PT) secondary to pseudotumor cerebri syndrome and often seek treatment from otolaryngologists because of this symptom. OBJECTIVE: To determine the effectiveness of weight reduction surgery (WRS) for relief of PT in patients with morbid obesity. STUDY DESIGN: Retrospective study of morbidly obese patients with associated PT. SETTING: Academic tertiary referral center. PATIENTS: Sixteen women with morbid obesity and associated PT who underwent WRS. RESULTS: Median age was 34 years (range 24-45 years). Average preoperative body mass index was 45 kg/m2 (range 33-70 kg/m2). Average weight loss was 45+/-17 kg (range 25-99 kg). Average postoperative weight was 75+/-14 kg (range 57-105 kg). The average preoperative cerebrospinal fluid pressure was 344+/-103 mm H2O (range 220-520 mm H2O). Postoperative measurements of cerebrospinal fluid, obtained on 4 patients, revealed an average decrease in pressure of 198 mm H2O (range 120-400 mm H2O). Thirteen patients experienced complete resolution of their PT (81%). Three patients continued to have PT despite significant weight reduction. CONCLUSIONS: Weight reduction surgery was effective in relieving PT in morbidly obese patients with associated pseudotumor cerebri syndrome and should be considered when conservative management has failed.

Ileal pouch anal anastomosis without ileal diversion.

OBJECTIVE: To evaluate continued experience with a one-stage stapled ileoanal pouch procedure without temporary ileostomy diversion. SUMMARY BACKGROUND DATA: Most centers perform colectomy, proctectomy, and ileal pouch anal anastomoses (IPAA) with a protective ileostomy. Following a previous report, the authors performed 126 additional stapled IPAA procedures for ulcerative colitis and familial adenomatous polyposis, of which all but 2 were without an ileostomy. Outcomes in these patients question the need for temporary ileal diversion, with its complications and need for subsequent surgical closure. METHODS: Two hundred one patients underwent a stapled IPAA since May 1989, 192 as a one-stage procedure without ileostomy, and 1 with a concurrent Whipple procedure for duodenal adenocarcinoma. Patient charts were reviewed or patients were contacted by phone to evaluate their clinical status at least 1 year after their surgery. RESULTS: Among the patients who underwent the one-stage procedure, 178 had ulcerative colitis (38 fulminant), 5 had Crohn's disease (diagnosed after IPAA), 1 had indeterminate colitis, and 8 had familial adenomatous polyposis. The mean age was 38 +/- 7 (range 7--70) years; there were 98 male patients and 94 female patients. The average amount of diseased tissue between the dentate line and the anastomosis was 0.9 +/- 0.1 cm, with 35% of the anastomoses at the dentate line. With 89% follow-up at 1 year or more (mean 5.1 +/- 2.4 years) after surgery, the average 24-hour stool frequency was 7.1 +/- 3.3, of which 0.9 +/- 1.4 were at night. Daytime stool control was 95% and night-time control was 90%. Only 2.3% needed to wear a perineal pad. Average length of hospital stay was 10 +/- 0.3 days, with 1.5 +/- 0.5 days readmission for complications. Abscesses or enteric leaks occurred in 23 patients; IPAA function was excellent in 19 of these patients (2 have permanent ileostomies). In patients taking steroids, there was no significant difference in leak rate with duration of use (29 +/- 8 with vs. 22 +/- 2 months without leak) or dose (32 +/- 13 mg with vs. 35 +/- 3 mg without leak). Two (1%) patients died (myocardial infarction, mesenteric infarction). CONCLUSIONS: The triple-stapled IPAA without temporary ileal diversion has a relatively low complication rate and a low rate of small bowel obstruction, provides excellent fecal control, permits an early return to a functional life, and can be performed in morbidly obese and older patients.

Chronically increased intra-abdominal pressure produces systemic hypertension in dogs.

OBJECTIVE: Determine if increased intra-abdominal pressure (IAP) alone can cause systemic hypertension in a chronic canine model. DESIGN: Evaluate effects of increase in IAP with progressive inflation and deflation of an intra-abdominal balloon on systemic blood pressure in experimental and control animals. SUBJECTS: Male dogs weighing 15-25 kg underwent placement of an intra-abdominal balloon which was progressively inflated on a weekly basis in the experimental animals (5) over 4 weeks to 25 mmHg above baseline and kept there for an additional 2 weeks before gradual deflation over 2 weeks. Control animals (5) had the balloon placed but not inflated. Pain was controlled with osmotic analgesic pumps. MEASUREMENTS: The animals were anesthetized, blood pressure (BP) measured and blood drawn for plasma renin activity (PRA), aldosterone, atrial naturetic peptide (ANP), catecholamines, and serum sodium (Na). A right heart catheter was inserted for measuring cardiac output (CO) and pulmonary artery occlusion pressure (PAOP) at baseline, week 5 (maximal IAP) and week 7 (after balloon deflation). The animals were weighed and urinary bladder pressures recorded weekly before and after abdominal balloon inflation. RESULTS: Systolic (122+/-3 to 155+/-5 mmHg, P<0.05) and diastolic (82+/-4 mmHg to 107+/-7 mmHg, P<0.05) BP rose at 5 weeks at 25 mmHg IAP>baseline and returned to control with balloon deflation. Both systolic and diastolic BP rose (P<0.05) above control animals BP at 15 mmHg IAP at 2 weeks and remained elevated until abdominal decompression, at week 7. There were no significant changes in net animal weight, PRA, aldosterone, ANF, catecholamines, Na, CO or PAOP. CONCLUSION: Increased IAP from progressively inflating an intra-abdominal balloon in dogs was associated with significant increases in systolic and diastolic BP that resolved with balloon deflation. Increased IAP may be a cause for systemic hypertension in central obesity and pre-eclampsia.

Complementary roles of laparoscopic abdominal exploration and diagnostic peritoneal lavage for evaluating abdominal stab wounds: a prospective study.

PURPOSE: To determine the roles of laparoscopic abdominal exploration (LE) and diagnostic peritoneal lavage (DPL) in the evaluation of abdominal stab wounds, we prospectively compared LE with mandatory celiotomy (MC) in 76 patients having anterior abdominal stab wounds penetrating the fascia over a 22-month period. PATIENTS AND METHODS: Twenty-two patients underwent emergency celiotomy. The remaining patients were subjected to DPL and assigned to treatment by either celiotomy or initial LE with subsequent conversion to open exploration at the discretion of the attending surgeon. RESULTS: Laparotomy was avoided in 55% of the 31 patients undergoing initial laparoscopy, and this group demonstrated a significant decrease in the incidence of nontherapeutic celiotomy, from 19% to 57% (P < 0.05), as well as decreased length of hospital stay (4 +/- 0.6 v 5.9 +/- 0.4 days; P < 0.05), and total hospital cost ($6119 +/- 756 v $8312 +/- 627; P < 0.05). There were no missed intraabdominal injuries or morbidity from laparoscopy identified in follow-up. The DPL (N = 36) was positive in 11 of the 12 patients with injury requiring surgical repair and was negative in 16 of the 25 patients not requiring repair. The sensitivity and specificity of DPL were 0.91 and 0.64 compared with 1.0 and 0.74 for laparoscopy. CONCLUSIONS: An algorithm to evaluate stable patients with anterior abdominal stab wounds and minimize overall costs of care, incidence of nontherapeutic celiotomy, and rate of missed injuries is suggested consisting of DPL followed by observation in patients with negative DPL and by laparoscopy in patients with positive DPL. Wounds to the thoracoabdominal region may be best evaluated by initial LE, as diaphragmatic wounds may result in a false-negative DPL.

Laparoscopic closure of mesenteric defects after Roux-en-Y gastric bypass.

Two case reports are presented of incarcerated small-bowel internal hernias through mesenteric defects following Roux-en-Y gastric bypass surgery (one case each of open and laparoscopic). Both patients first presented to physicians unfamiliar with bariatric surgery complaining of vague, cramping midabdominal pain, and the correct diagnosis was not revealed until laparoscopic surgery was performed. Treatment then resulted in quick recoveries. This type of hernia can evade radiologic testing. Prompt clinical recognition and treatment is necessary to prevent small-bowel infarction.