Rami Lutfi

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.

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.

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.

Endoscopic evaluation of the gastrojejunostomy in laparoscopic gastric bypass. A series of 340 patients without postoperative leak.

BackgroundA significant and potentially deadly complication of the Roux-en-Y gastric bypass is leakage from the gastrojejunostomy (GJ). The aim of our study was to evaluate the efficacy of intraoperative endoscopy in preventing postoperative anastomotic leakage.MethodsThe study enrolled 340 consecutive patients undergoing laparoscopic gastric bypass procedures performed from January 2001 to July 2004. In all cases, an endoscopist performed video gastroscopy to evaluate the integrity of the GJ using air insufflation of the pouch after distal clamping of the Roux limb. Intraoperative leaks were repaired and the anastomosis was retested. Demographic, operative, and endoscopic data were collected and analyzed. Logistic regression was used in both univariate and multivariate modeling to identify independent preoperative variables associated with the presence of intraoperative leak. Model parameters were estimated by the maximum likelihood method. From these estimates, odds ratios (ORs) with 95% confidence intervals (CIs) were computed.ResultsThere were no postoperative anastomotic leaks or mortalities in our series. Overall, endoscopic evaluation of the GJ resulted in the detection of 56 intraoperative leaks (16.4%). There was a significant difference in the incidence of intraoperative leakage for patients older than 40 years (21%) vs those younger than 40 years (10.5%; p = 0.01). In the initial 91 cases, the GJ was performed by the end-to-end anastomosis (EEA) technique; the subsequent 249 were performed with a combination of linear stapling and handsewn technique. There was a trend toward more leakage in the GIA group (18%) versus EEA (12%); however, the difference was not significant (p = 0.188). Age remained an independent risk factor for leak detected intraoperatively in the multivariate logistic regression model after adjusting for covariates. Age >40 years increased the risk of intraoperative leakage by 2.3 times (OR, 2.3; 95% CI, 1.2–4.6; p = 0.01). The rate of postoperative anastomotic stricture was the same among patients detected with an intraoperative leak (5.4%) and those without (5.6%; p = 0.934).ConclusionsEndoscopic evaluation of the GJ is a sensitive and reliable technique for demonstrating anastomotic integrity and preventing postoperative morbidity after gastric bypass. Age >40 years was identified as an independent risk factor for intraoperative leak in this series.

Heller myotomy vs Heller myotomy plus Dor fundoplication: cost-utility analysis of a randomized trial.

BackgroundThe addition of a Dor antireflux procedure reduces the risk of pathologic gastroesophageal reflux (GER) by ninefold following laparoscopic Heller myotomy for achalasia. It is not clear, however, how these benefits compare with the increased cost of the fundoplication. The objective of this study was to estimate the cost-effectiveness of Heller myotomy plus Dor fundoplication compared with Heller alone in patients with achalasia.MethodsWe conducted a cost–utility analysis using the Markov simulation model to examine the two treatment alternatives. The model estimated the total expected costs of each strategy over a 10-year time horizon. Data for the model were derived from our randomized clinical trial. The strategies were compared using the method of incremental cost-effectiveness analysis.ResultsThe incidence of pathologic GER was 47.6% (10 of 21 patients) in the Heller group and 9.1% (2 of 22 patients) in the Heller plus Dor group using an intention-to-treat analysis (p = 0.005). Heller plus Dor was associated with a significant reduction in the risk of GERD (relative risk 0.11; 95% confidence interval 0.02–0.59; p = 0.01). The cost of surgery was significantly higher for Heller plus Dor than for Heller alone (mean difference

Laparoendoscopic single-site gastric bands versus standard multiport gastric bands: a comparison of technical learning curve measured by surgical time

942; p = 0.04), secondary to a longer operating room time (mean difference 40 min; p = 0.01). At a time horizon of 10 years, when proton pump inhibitor (PPI) therapy costs are considered, the cost–utility analysis demonstrates that Heller plus Dor surgery is associated with a total cost of

Endoscopic treatment modalities for gastroesophageal reflux disease

6,861 per patient and a quality-adjusted life expectancy of 9.9 years, whereas Heller-alone surgery is associated with a cost of

The endoscopic radiofrequency approach to management of GERD.

9,541 per patient and a quality-adjusted life expectancy of 9.5 years.ConclusionsIn achalasia patients, Heller myotomy plus Dor fundoplication is preferred to Heller alone because it is both more effective in preventing postoperative GERD and more cost-effective at a time horizon of 10 years.