Alfonso Torquati

Heller myotomy versus Heller myotomy with Dor fundoplication for achalasia: a prospective randomized double-blind clinical trial.

Objective:We sought to determine the impact of the addition of Dor fundoplication on the incidence of postoperative gastroesophageal reflux (GER) after Heller myotomy. Summary Background Data:Based only on case series, many surgeons believe that an antireflux procedure should be added to the Heller myotomy. However, no prospective randomized data support this approach. Patients and Methods:In this prospective, randomized, double-blind, institutional review board-approved clinical trial, patients with achalasia were assigned to undergo Heller myotomy or Heller myotomy plus Dor fundoplication. Patients were studied via 24-hour pH study and manometry at 6 months postoperatively. Pathologic GER was defined as distal esophageal time acid exposure time greater than 4.2% per 24-hour period. The outcome variables were analyzed on an intention-to-treat basis. Results:Forty-three patients were enrolled. There were no differences in the baseline characteristics between study groups. Pathologic GER occurred in 10 of 21 patients (47.6%) after Heller and in 2 of 22 patients (9.1%) after Heller plus Dor (P = 0.005). Heller plus Dor was associated with a significant reduction in the risk of GER (relative risk 0.11; 95% confidence interval 0.02–0.59; P = 0.01). Median distal esophageal acid exposure time was lower in the Heller plus Dor (0.4%; range, 0–16.7) compared with the Heller group (4.9%; range, 0.1–43.6; P = 0.001). No significant difference in surgical outcome between the 2 techniques with respect to postoperative lower-esophageal sphincter pressure or postoperative dysphagia score was observed. Conclusions:Heller Myotomy plus Dor Fundoplication was superior to Heller myotomy alone in regard to the incidence of postoperative GER.

Predictors of success after laparoscopic gastric bypass: a multivariate analysis of socioeconomic factors

BackgroundLaparoscopic gastric bypass (LGB) has proven efficacy in causing significant and durable weight loss. However, the degree of postoperative weight loss and metabolic improvement varies greatly among individuals. Our study is aimed to identify independent predictors of successful weight loss after LGB.MethodsSocioeconomic demographics were prospectively collected on patients undergoing LGB. Primary endpoint was percent of excess weight loss (EWL) at 1-year follow-up. Insufficient weight loss was defined as EWL ≤−1 SD from mean EWL. Logistic regression was used in both univariate and multivariate models to identify independent preoperative demographics associated with successful weight loss.ResultsA total of 180 consecutive patients were enrolled over 30 months. Mean preoperative body mass index (BMI) was 48. Mean EWL was 70.1 ± 17.3% (1 SD); therefore, success was defined as EWL ≥52.8%. According to this definition, 147 patients (81.7%) achieved successful weight loss 1 year after LGB. On univariate analysis, preoperative BMI had a significant effect on EWL, with patients with BMI <50 achieving a higher percentage of EWL (91.7% vs 61.6%; p = 0.001). Marriage status was also a significant predictor of successful outcome, with single patients achieving a higher percentage of EWL than married patients (89.8% vs 77.7%; p = 0.04).Race had a noticeable but not statistically significant effect, with Caucasian patients achieving a higher percentage of EWL than African Americans (82.9% vs 60%; p = 0.06). Marital status remained an independent predictor of success in the multivariate logistic regression model after adjusting for covariates. Married patients were at more than two times the risk of failure compared to those who were unmarried (OR 2.6; 95% CI: 1.1–6.5, p = 0.04).ConclusionsWeight loss achieved at 1 year after LGB is suboptimal in superobese patients. Single patients with BMI < 50 had the best chance of achieving greater weight loss.

Is Roux-en-Y gastric bypass surgery the most effective treatment for type 2 diabetes mellitus in morbidly obese patients?

Type 2 diabetes mellitus (T2DM) has a very strong association with obesity. The aim of our study was to analyze the effects of Roux-en-Y gastric bypass (RYGB) surgery on the glucose metabolism in morbidly obese patients with T2DM. Morbidly obese patients (n = 117) with T2DM underwent measurements of fasting serum glucose and glycosylated hemoglobin (HbA1C) at baseline, 6 months, and 12 months after laparoscopic RYGB surgery. Logistic regression was used in both univariate and multivariate modeling to identify independent variables associated with complete resolution of T2DM. Twelve months after surgery, fasting plasma glucose decreased from a preoperative mean of 164 ± 55 mg/dL to 101 ± 38 mg/dL (P = .001) and HbA1C decreased from a preoperative mean of 7.7% ±1.5% to 6.0% ± 1.1% (P = .001). Resolution of T2DM was achieved in 72 patients (74%). All of the remaining 25 patients decreased the daily medication requirements. On univariate analysis, preoperative variables associated with resolution of T2DM were waist circumference, HbA1C, and absence of insulin treatment. Waist circumference (odds ratio 2.4; 95% confidence interval 1.4- 4.1; P = .001) and treatment without insulin (odds ratio 42.2; 95% confidence interval 4.3-417.3; P = .002) remained significant predictors of T2DM resolution in the multivariate logistic regression model after adjusting for covariates. Laparoscopic RYGBP resulted in significant resolution of T2DM. Peripheral fat distribution (smaller waist circumference) and absence of insulin treatment were independent and significant predictors of complete resolution of T2DM.

Laparoscopic Myotomy for Achalasia: Predictors of Successful Outcome After 200 Cases

Objective:Laparoscopic myotomy is the preferred treatment of achalasia. Our objectives were to assess the long-term outcome of esophageal myotomy and to identify preoperative factors influencing the outcome. Methods:Preoperative and long-term outcome data were collected from patients undergoing laparoscopic myotomy for achalasia at our institution. The primary endpoint of the study was the postoperative change (delta) in dysphagia score. This score was calculated by combining the frequency and the severity of dysphagia. Persistent postoperative dysphagia was defined as 1 standard deviation less than the mean delta score of all patients. Logistic regression was used to identify independent preoperative factors associated with successful myotomy. Results:A total of 200 consecutive patients were included in the study. At a mean follow-up of 42.1 months, the mean delta dysphagia score was 7.1 ± 2.6; therefore, the myotomy was considered successful when the delta score was >4.5. According to this definition, 170 (85%) patients achieved excellent dysphagia relief (responders). Responders had higher preoperative low esophageal sphincter (LES) pressure than nonresponders: 42.6 ± 13.1 versus 23.8 ± 7.0 mm Hg (P = 0.001). High preoperative LES pressure remained an independent predictor of excellent response in the multivariate logistic regression model. Patients with LES pressure >35 mm Hg had an odds ratio of 21.3, making more likely to achieve excellent dysphagia relief after myotomy compared with those with LES pressure ≤35 mm Hg (odds ratio, 21.3; 95% confidence interval, 6.1–73.5, P = 0.0001). Conclusion:Laparoscopic myotomy can durably relieve symptoms of dysphagia. Elevated preoperative LES pressure represents the strongest positive outcome predictor.

Weight, Dietary and Physical Activity Behaviors Two Years after Gastric Bypass

Background: This cross-sectional survey was designed to determine the self-reported weight management, dietary and physical activity behaviors of Roux-en-Y gastric bypass (RYGBP) patients who were 1 to 4 years after the RYGBP operation, and to identify gaps in follow-up nutrition-related chronic disease prevention. Methods: Questionnaires including behavioral items from the 2003 and 2004 Behavioral Risk Factor Surveillance System (BRFSS) were mailed to all RYGBP patients in a clinically active outpatient database. Results: Of 212 patients, 140 (66%) returned completed questionnaires. Responders were 24.2 ± 7.9 months postoperatively. They were older than nonresponders (45.2 ± 9.9 vs 38.5 ± 8.9 years, P<.001). Responders had an average weight loss of 55.8 ± 15.2 kg, and most (81%) reported that they were still trying to lose weight. The most frequently reported dietary behavior for weight loss was decreasing calorie and fat intakes. However, in addition to avoiding sodas and sweet desserts, responders were also excluding nutrient-dense foods high in vitamins and minerals such as milk and dairy products, red meats, breads, cereals and nuts. Remarkably, only 25 (17.9%) engaged in regular exercise activities before surgery, while 116 (82.9%) indicated a moderate level of current physical activity averaging 54.7 ± 38.5 minutes per episode. Multivariable linear regression analyses identified age, weight at age 21, pre-surgery BMI and time in regular physical activities as the four significant predictors of BMI after weight loss stabilization. Conclusion: Postoperative RYGBP patients engage in various weight management behaviors, some of which could offer greater health benefits with follow-up intervention from dietitians and exercise specialists to prevent adverse outcomes such as weight regain and micronutrient deficiencies.

Paradigm Shift in the Management of Gastroesophageal Reflux Disease

ObjectiveTo compare the short-term results of the radiofrequency treatment of the gastroesophageal junction known as the Stretta procedure versus laparoscopic fundoplication (LF) in patients with gastroesophageal reflux disease (GERD). Summary Background DataThe Stretta procedure has been shown to be safe, well tolerated, and highly effective in the treatment of GERD. MethodsAll patients presenting to Vanderbilt University Medical Center for surgical evaluation of GERD between August 2000 and March 2002 were prospectively evaluated under an IRB-approved protocol. All patients underwent esophageal motility testing and endoscopy that documented GERD preoperatively, either by a positive 24-hour pH study or biopsy-proven esophagitis. Patients were offered the Stretta procedure if they had documented GERD and did not have a hiatal hernia larger than 2 cm, LES pressure less than 8 mmHg, or Barrett’s esophagus. Patients with larger hiatal hernias, LES pressure less than 8 mmHg, or Barrett’s were offered LF. All patients were studied pre- and postoperatively with validated GERD-specific quality-of-life questionnaires (QOLRAD) and short-form health surveys (SF-12). Current medication use and satisfaction with the procedure was also obtained. ResultsResults are reported as mean ± SEM. Seventy-five patients (age 49 ± 14 years, 44% male, 56% female) underwent LF and 65 patients (age 46 ± 12 years, 42%, 58% female) underwent the Stretta procedure. Preoperative esophageal acid exposure time was higher in the LF group. Preoperative LES pressure was higher in the Stretta group. In the LF group, 41% had large hiatal hernias (>2 cm), 8 patients required Collis gastroplasty, 6 had Barrett’s esophagus, and 10 had undergone previous fundoplication. At 6 months, the QOLRAD and SF-12 scores were significantly improved within both groups. There was an equal magnitude of improvement between pre- and postoperative QOLRAD and SF-12 scores between Stretta and LF patients. Fifty-eight percent of Stretta patients were off proton pump inhibitors, and an additional 31% had reduced their dose significantly; 97% of LF patients were off PPIs. Twenty-two Stretta patients returned for 24-hour pH testing at a mean of 7.2 ± 0.5 months, and there was a significant reduction in esophageal acid exposure time. Both groups were highly satisfied with their procedure. ConclusionsThe addition of a less invasive, endoscopic treatment for GERD to the surgical algorithm has allowed the authors to stratify the management of GERD patients to treatment with either Stretta or LF according to size of hiatal hernia, LES pressure, Barrett’s esophagus, and significant pulmonary symptoms. Patients undergoing Stretta are highly satisfied and have improved GERD symptoms and quality of life comparable to LF. The Stretta procedure is an effective alternative to LF in well-selected patients.

Long-term follow-up study of the Stretta procedure for the treatment of gastroesophageal reflux disease

BackgroundThe endoscopic delivery of temperature-controlled radiofrequency energy to the gastroesophageal junction (Stretta procedure) recently has been shown effective for patients with gastroesophageal reflux disease (GERD). However, its effectiveness has been assessed mainly over short periods (6–12 months). This study aimed to evaluate long-term results of the Stretta procedure.MethodsAll patients undergoing the Stretta procedure since August 2000 were prospectively evaluated under an institutional review board–approved protocol. All patients with a follow-up period longer than 18 months were recruited for a 24-h pH study and mailed a follow-up survey, which included the following: Short Form 12 (SF-12) health status questionnaire, GERD-specific quality-of-life questionnaire (QOLRAD), and queries regarding long-term satisfaction and medication use.ResultsThe Stretta procedure was performed on 82 patients, and 41 patients with a follow-up period longer than 18 months qualified for the study. Follow-up surveys were completed by 36 patients (88%) during a mean follow-up period of 27.1 ± 3.7 months. Of these 36 patients, 30 (83%) were highly satisfied with the procedure and would have it performed again. More than half of the Fifty Stretta patients (56%) had completely discontinued their use of proton pump inhibitors (PPIs), and an additional 31% had reduced their dose significantly. The mean PPI equivalent doses were 37.8 ± 22.2 mg/day before the Stretta procedure and 11.6 ± 14.6 mg/day at 27-month follow-up assessment (p = 0.001). According to the patient outcomes for daily PPI use (yes/no), the patients were divided into two groups: responders (n = 20) and nonresponders (n = 16). The responder group scored higher in QOLRAD score (p = 0.0001), SF-12 physical score (p = 0.038), and SF-12 mental score (p = 0.003). In the 24-hour pH study, the responder group demonstrated a significant decrease in distal esophageal acid exposure time (6.4% ± 1.5% to 3.1% ± 1.4%; p = 0.0001).ConclusionThe Stretta procedure results in a statistical significant long-term decrease in GERD symptoms and PPI use. The treatment effect is durable beyond 2 years, and 56% of patients had discontinued their user of all antisecretory drugs.

Experience with the optical access trocar for safe and rapid entry in the performance of laparoscopic gastric bypass

BackgroundIn laparoscopic surgery, serious complications caused by the blind insertion of trocars are well known. The open technique is compromised by the leakage of carbon dioxide and can also be time consuming, especially in morbidly obese patients. Our aim was to determine whether the optical access trocar can be used to establish a safe and rapid entry during laparoscopic gastric bypass.MethodsThe data on a single surgeon’s experience with 370 laparoscopic gastric bypass procedures during a 4-year period were reviewed. The Optiview trocar was used for all except the initial 21 patients. The entry time for the optical trocar was measured in 10 patients.ResultsOf the 370 patients undergoing laparoscopic gastric bypass from November 2000 to September 2004, the initial 21 were treated using the standard Veress needle to create the pneumoperitoneum. The next 22 were treated using the Veress needle to create the pneumoperitoneum, followed by insertion of the optical access trocar in the left upper quadrant as the initial trocar. From this point to the present, the optical access trocar has been inserted without the use of a Veress needle. There have been no trocar-related bowel or vascular injuries in the entire series. The mean optical trocar insertion time was 28 ± 1.2 s.ConclusionsThis is the first laparoscopic gastric bypass series to report the results of its experience with the optical access trocar. This device provides a safe and rapid technique for placement of the initial trocar for laparoscopic gastric bypass. Insertion of the optical trocar with a 10-mm laparoscope into the left upper quadrant is our procedure of choice for obtaining the pneumoperitoneum in this patient population.

Gastric Bypass Surgery Leads to Long-term Remission or Improvement of Type 2 Diabetes and Significant Decrease of Microvascular and Macrovascular Complications.

Objectives:The aim of the study was to compare long-term outcomes of 2 groups of morbidly obese patients with type 2 diabetes mellitus—1 managed by Roux-en-Y gastric bypass surgery and a comparable group managed medically. Methods:The present study was a single-institution retrospective study. Of the 173 obese patients with type 2 diabetes mellitus undergoing gastric bypass surgery between January 2000 and July 2004, 78 patients (45%) were followed for at least 10 years. The control group consisted of 80 diabetic obese patients from the same period with similar body mass index, age, race, and severity of diabetes. The median follow-up was 11 years for both the groups. Results:The group undergoing gastric bypass surgery had greater percentage of excess weight loss than the control group—66% versus −1.6%, respectively. Forty-one patients (52.6%) in the surgery group had complete remission of diabetes and 5 (6.4%) had partial remission. Twelve patients (15.4%) had diabetes recurrence after initial remission. No patient in the control group had remission of diabetes. Compared with the control group, the group undergoing gastric bypass surgery had a significantly reduced incidence of microvascular complications—46.3% versus 11.5%, and macrovascular complications—20.3% versus 5%, respectively (P < 0.01). Conclusions:In this study, we demonstrated that after 10 years of follow-up, Roux-en-Y gastric bypass surgery, compared with nonsurgical medical management, resulted in significantly greater weight loss, reduction in hemoglobin A1c, and use of antidiabetic medications, and very importantly a lower incidence of both microvascular and macrovascular complications in obese patients with type 2 diabetes.

Three year’s experience with the Stretta procedure: did it really make a difference?

BackgroundEndoscopic treatment is merging as a new option for GERD treatment. Many modalities have been used with modest short-term success, but no long-term follow-ups have been published. We present our 3-yr experience at Vanderbilt University using endoscopic radiofrequency energy (Stretta procedure) for GERD treatment.MethodsPatients with follow-up >6 months were prospectively studied under IRB protocol. All were mailed SF-12 health status questionnaire and GERD specific quality-of-life (QOLRAD) questionnaires, queries about satisfaction with Stretta, and medication use. All were invited for 24-hour pH study.ResultsEighty-six Stretta procedures were performed between 8/2000 and 7/2003 on 85 patients; all were outpatients, 89% under conscious sedation. Seventy-seven patients qualified for the study; 61 completed the survey, 24 returned for pH study. Follow-up was 26.2 +/- 7.5 months (6-36). All were on daily PPIs, with proven GERD by pH study or endoscopy. Mean preoperative acid exposure time was 7.8+/-2.6%, mean DeMeester score was 40.2+/-17.6. Postoperative mean acid exposure time was 5.1+/-3.3 (p=0.00l), DeMeester score was 29.5+/-20.5 (p=0.041). Normal postoperative acid exposure time (pH<4 in <4.2%) was achieved in 42% of patients tested. Patients were then divided according to medication use at the end of f/u in 2 groups: Responders (off or >50% decrease in PPI dose), and nonresponders (on >50% of original PPI dose, or had fundoplication). Response rate was 60% (39 patients), 8 nonresponders underwent fundoplication (12%). Satisfaction rate was 73%. Statistically significant difference was found between the 2 groups in all measurements; SF-12 physical and mental score for responders were 45.5+/-10.2, and 52.6+/-7.8; and for nonresponders were 37.8+/-11.2 and 40.9+/-11.3 (p=0.012, p=0.000l), respectively. Statistically significant difference was also found between responders and nonresponders in postoperative acid exposure (4.5+/-3.34 vs 7.2+/-2.3, p=0.034), and DeMeester score (26.3+/-20.4 vs 39.7+/-20.2, p=0.05). Paired T test was used to compare pre- and postoperative acid exposure in each group; statistically significant difference was found only among responders: total reflux time was 7.50+/-2.3 preop and 4.5+/-3.34 postop (p=0.000l), whereas for nonresponders it was 8.6+/-3.7 and 7.2+/-2.3 (p=0.8), DeMeester scores pre- and postop among responders were 40.0+/-19.7 and 26.3+/-20.4, respectively (p=0.016), whereas for nonresponders it was 40.5+/-14.3 and 39.7+/-20.2 (p=0.79).ConclusionsStretta is a safe modestly effective, totally endoscopic treatment for GERD. Symptomatic improvement when achieved is often associated with correlating improvement in distal acid exposure. This exposure normalizes in nearly half the treated patients.