Sleeve Gastrectomy Performed with Single Staple Height and Bioabsorbable Reinforcement in a Single Surgeon > 2500 Consecutive Case Series: Is Smart Technology Necessary?

BACKGROUND: Laparoscopic sleeve gastrectomy (LSG) is shown to have durable and sustained weight reduction outcomes and improvement in comorbid conditions in patients with severe clinical obesity. Discussions regarding "proper" staple height for various gastric locations continue. We propose a standard approach of consistent use of single staple load height and bioabsorbable staple line reinforcement during the LSG to reduce variability. METHODS: A retrospective chart review of 2556 consecutive cases of adult patients who underwent LSG evaluated perioperative complications, postoperative leaks or bleeding, and average weight and body mass index (BMI) change and excess weight loss (EWL) at 6, 12, and 24 months. The same green staple load (2.0 mm) and staple line reinforcement were used in all cases for all staple firings, regardless of patient size or gastric location. RESULTS: Patients were a mean age of 42 years, 87.3% were female, and the mean preoperative weight was 134.2 kg and BMI was 48.2 kg/m2. No staple line leak was detected. Three bleeding events occurred but did not require readmission or rehospitalization. Mean EWL and BMI, respectively, were 49.0% and 35.5 kg/m2 at 6 months, 69.8% and 29.6 kg/m2 at 12 months, and 70.0% and 29.5 kg/m2 at 24 months. CONCLUSION: In this case series of 2556 consecutive LSG performed by a single surgeon, clinically meaningful EWL and decreased BMI were achieved. Streamlining the LSG procedure by utilizing the same staple height and a bioabsorbable staple line reinforcement proved safe with minimal complications.

Randomized sham-controlled trial of the 6-month swallowable gas-filled intragastric balloon system for weight loss.

BACKGROUND: Obesity is a significant health problem and additional therapies are needed to improve obesity treatment. OBJECTIVE: Determine the efficacy and safety of a 6-month swallowable gas-filled intragastric balloon system for weight loss. SETTING: Fifteen academic and private practice centers in the United States. METHODS: This was a double-blind, randomized sham-controlled trial of the swallowable gas-filled intragastric balloon system plus lifestyle therapy compared with lifestyle therapy alone for weight loss at 6 months in participants aged 22 to 60 years with body mass index 30 to 40 kg/m2, across 15 sites in the United States. The following endpoints were included: difference in percent total weight loss in treatment group versus control group was >2.1%, and a responder rate of >35% in the treatment group. RESULTS: Three hundred eighty-seven patients swallowed at least 1 capsule. Of participants, 93.3% completed all 24 weeks of blinded study testing. Nonserious adverse events occurred in 91.1% of patients, but only .4% were severe. One bleeding ulcer and 1 balloon deflation occurred. In analysis of patients who completed treatment, the treatment and control groups achieved 7.1 ± 5.0% and 3.6 ± 5.1% total weight loss, respectively, and a mean difference of 3.5% (P = .0085). Total weight loss in treatment and control groups were 7.1 ± 5.3 and 3.6 ± 5.1 kg (P < .0001), and body mass index change in the treatment and control groups were 2.5 ± 1.8 and 1.3 ± 1.8 kg/m2 (P < .0001), respectively. The responder rate in the treatment group was 66.7% (P < .0001). Weight loss maintenance in the treatment group was 88.5% at 48 weeks. CONCLUSIONS: Treatment with lifestyle therapy and the 6-month swallowable gas-filled intragastric balloon system was safe and resulted in twice as much weight loss compared with a sham control, with high weight loss maintenance at 48 weeks.

Randomized sham-controlled trial evaluating efficacy and safety of endoscopic gastric plication for primary obesity: The ESSENTIAL trial.

OBJECTIVE: Evaluate safety and efficacy of the pose™ procedure for obesity treatment. METHODS: Subjects with Class I to II obesity were randomized (2:1) to receive active or sham procedure, after each investigator performed unblinded lead-in cases. All subjects were provided low-intensity lifestyle therapy. Efficacy end points were the mean difference in percent total body weight loss (%TBWL) at 12 months between randomized groups, and responder rate achieving ≥5% TBWL. The primary safety end point was incidence of reported adverse events. RESULTS: Three hundred thirty-two subjects were randomized (active, n = 221; sham, n = 111); thirty-four subjects were included in the unblinded lead-in cohort. Twelve-month results were mean TBWL 7.0 ± 7.4% in lead-in, 4.95 ± 7.04% in active, and 1.38 ± 5.58% in sham groups, respectively. Responder rate was 41.55% in active and 22.11% in sham groups, respectively (P < 0.0001); mean responder result was 11.5% TBWL. The differences observed between active and sham groups for co-primary end points were statistically significant (P < 0.0001); however, super superiority margin as set forth in the study design was not met. No unanticipated adverse events or deaths occurred. Procedure-related serious adverse event rates were 5.0% (active) and 0.9% (sham), P = 0.068. CONCLUSIONS: The pose procedure was safe and resulted in statistically significant and clinically meaningful weight loss over sham through 1 year.

Delayed gastric emptying as a proposed mechanism of action during intragastric balloon therapy: Results of a prospective study.

OBJECTIVE: The effects of intragastric balloon (IGB) therapy on gastric emptying (GE) and weight loss remain to be fully understood. The effects of IGB on GE were investigated in this study. METHODS: This was a single-center, randomized, controlled study in which subjects with obesity either underwent IGB placement or were matched controls. IGB was removed at 6 months. GE was measured at baseline and at weeks 0, 8, 16, 27, and 39. Percent total body weight loss (%TBWL) was measured at 6 and 12 months. RESULTS: Twenty-nine subjects with obesity were enrolled; 15 were randomized to IGB placement and 14 to control. Two subjects had the IGB removed early. At baseline, 1- and 2-h gastric retention values were comparable between the groups but increased in the IGB group at weeks 8 and 16 (during IGB treatment) and then returned to baseline levels at 27 and 39 weeks. A greater increase in gastric retention from baseline to 8 weeks was associated with higher %TBWL. CONCLUSIONS: GE in subjects with IGB is delayed but returns to normal after IGB removal. Greater changes in increased gastric retention were associated with greater %TBWL. Altering gastric motility is a significant mechanism of action by which the IGB results in weight loss.

The REDUCE pivotal trial: a prospective, randomized controlled pivotal trial of a dual intragastric balloon for the treatment of obesity.

BACKGROUND: Saline-filled intragastric balloon devices are reversible endoscopic devices designed to occupy stomach volume and reduce food intake. OBJECTIVE: To evaluate the safety and effectiveness of a dual balloon system plus diet and exercise in the treatment of obesity compared to diet and exercise alone. SETTING: Academic and community practice, United States. METHODS: Participants (n = 326) with body mass index (BMI) 30-40 kg/m(2) were randomized to endoscopic DBS treatment plus diet and exercise (DUO, n = 187) or sham endoscopy plus diet and exercise alone (DIET, n = 139). Co-primary endpoints were a between-group comparison of percent excess weight loss (%EWL) and DUO subject responder rate, both at 24 weeks. Thereafter DUO patients had the DBS retrieved followed by 24 additional weeks of counseling; DIET patients were offered DBS treatment. RESULTS: Mean BMI was 35.4. Both primary endpoints were met. DUO weight loss was over twice that of DIET. DUO patients had significantly greater %EWL at 24 weeks (25.1% intent-to-treat (ITT), 27.9% completed cases (CC, n = 167) compared with DIET patients (11.3% ITT, P = .004, 12.3% CC, n = 126). DUO patients significantly exceeded a 35% response rate (49.1% ITT, P<.001, 54.5% CC) for weight loss dichotomized at 25%EWL. Accommodative symptoms abated rapidly with support and medication. Balloon deflation occurred in 6% without migrations. Early retrieval for nonulcer intolerance occurred in 9%. Gastric ulcers were observed; a minor device change led to significantly reduced ulcer size and frequency (10%). CONCLUSION: The DBS was significantly more effective than diet and exercise in causing weight loss with a low adverse event profile.

A direction-sensitive underwater blast detector and its application for managing blast fishing.

Little is known about the spatial and temporal distribution of blast fishing which hampers enforcement against this activity. We have demonstrated that a triangular array of hydrophones 1 m apart is capable of detecting blast events whilst effectively rejecting other sources of underwater noise such as snapping shrimp and nearby boat propellers. A total of 13 blasts were recorded in Sepangor bay, North of Kota Kinabalu, Sabah, Malaysia from 7th to 15th July 2002 at distances estimated to be up to 20 km, with a directional uncertainty of 0.2 degrees . With such precision, a network of similar hydrophone arrays has potential to locate individual blast events by triangulation to within 30 m at a range of 10 km.

Acoustic characteristics of fish bombing: potential to develop an automated blast detector.

The use of explosives to catch fish has caused extensive damage to coral reefs throughout Southeast Asia, but the frequency with which they are used is largely unknown. The aim of this work is to develop a detection system capable of distinguishing underwater explosions from background noise, and locating their origin by triangulation. Blast signals have been recorded over a range of distances and the key features that differentiate them from background noise have been determined. For small charges the effective range of such a detector is more than 12 km and may extend up to 50 km depending on the mass of the charges being used. Such a system would help to determine the scale of the problem, identify areas at greatest risk and quantify the effectiveness of management intervention designed to control destructive fishing practices. It may assist with fisheries enforcement in some areas.

Effect of adjustable gastric banding on changes in gastroesophageal reflux disease (GERD) and quality of life.

OBJECTIVE: Bariatric surgery is an effective treatment for the reduction of weight in obese patients (BMI ≥ 40 kg/m(2) or 30 kg/m(2) with ≥1 comorbidities), who are refractory to behavioral and medical therapies. This study examined the effect of the adjustable gastric band (AGB) system on changes in gastroesophageal reflux disease (GERD) and patient-reported outcomes, including measures of quality of life. METHODS: Two-year interim analysis of patients (N = 171) in the 5 year, prospective APEX study who reported GERD prior to the AGB procedure. An unrecorded number of hiatal hernia repairs were conducted during the APEX study. RESULTS: At baseline, 171 of 395 patients (43%) reported GERD requiring daily medical therapy. After 2 years, 122 patients had sufficient data to assess outcome (71%). Complete resolution of GERD was reported in 98 patients (80%), improvement in 13 (11%), no change in 9 (7%), and worsening in 2 (2%). Overall, 91% of GERD patients experienced resolution and/or improvement of GERD. Baseline BMI was not significantly different among the GERD response categories (resolved, improved, and stable/worse), p = 0.4581. Mean ΔBMI and percentage excess weight loss (%EWL) were: -8.8 kg/m(2)/-0.9%, -11.4 kg/m(2)/-53.9%, -6.4 kg/m(2)/-36.1%, and -7.1 kg/m(2)/-31.2%, respectively. There were no significant differences in reductions in BMI or %EWL between responder groups (resolved versus stable/worse ΔBMI p = 0.1031, %EWL p = 0.0667 OR resolved/improved versus stable/worse ΔBMI p = 0.0918, %EWL p = 0.0552). After 2 years, resolution or improvement occurred in pre-existing comorbidities: type 2 diabetes (96%), hypertension (91%), hyperlipidemia (77%), obstructive sleep apnea (86%), osteoarthritis (93%), and depression (75%). Patient satisfaction with AGB was assessed as: very satisfied/satisfied (87%), very satisfied (50%), dissatisfied (5.0%). Quality of life measured by the Obesity and Weight-Loss Quality of Life Instrument (GERD patients) significantly improved from baseline. CONCLUSION: Obese patients with GERD had meaningful improvement in patient-reported outcomes with the AGB system. In addition, other obesity-related comorbidities and measures of quality of life improved.