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"Gastroplasty - instrumentation"
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Closed-loop gastric electrical stimulation versus laparoscopic adjustable gastric band for the treatment of obesity: a randomized 12-month multicenter study
by
Horbach, T
,
Morales-Conde, S
,
Susewind, M
in
692/308/2779/109
,
692/699/2743/393
,
692/700/565/2194
2016
Objective:
To compare the weight loss, change in quality of life (QOL) and safety of closed-loop gastric electrical stimulation (CLGES) versus adjustable gastric band (LAGB) in the treatment of obesity.
Methods:
This multicenter, randomized, non-inferiority trial randomly assigned the patients in a 2:1 ratio to laparoscopic CLGES versus LAGB and followed them for 1 year. We enrolled 210 patients, of whom 50 were withdrawn preoperatively. Among 160 remaining patients (mean age=39±11 years; 75% women; mean body mass index=43±6 kg m
–
2
) 106 received CLGES and 54 received LAGB. The first primary end point was non-inferiority of CLGES versus LAGB, ascertained by the proportion of patients who, at 1 year, fulfilled: (a) a ⩾20% excess weight loss (EWL); (b) no major device- or procedure-related adverse event (AE); and (c) no major, adverse change in QOL. Furthermore, ⩾50% of patients had to reach ⩾25% EWL. The incidence and seriousness of all AE were analyzed and compared using Mann–Whitney’s
U-
test.
Results:
At 1 year, the proportions of patients who reached all components of the primary study end point were 66.7 and 73.0% for the LAGB and CLGES group, respectively, with a difference of –6.3% and an upper 95% CI of 7.2%, less than the predetermined 10% margin for confirming the non-inferiority of CLGES. The second primary end point was also met, as 61.3% of patients in the CLGES group reached ⩾25% EWL (lower 95% CI=52.0%;
P
<0.01). QOL improved significantly and similarly in both groups. AE were significantly fewer and less severe in the CLGES than in the LAGB group (
P
<0.001).
Conclusions and relevance:
This randomized study confirmed the non-inferiority of CLGES compared with LAGB based on the predetermined composite end point. CLGES was associated with significantly fewer major AE.
Journal Article
Efficacy of Ultrasound-Guided Transversus Abdominis Plane Block After Laparoscopic Bariatric Surgery: a Double Blind, Randomized, Controlled Study
by
Punhani, Dinesh
,
Jayaraman, Lakshmi
,
Sinha, Aparna
in
Abdominal Muscles - drug effects
,
Abdominal Muscles - innervation
,
Adolescent
2013
Background
The efficacy of ultrasound-guided transversus abdominis plane (USG-TAP) block as a part of multimodal analgesia was evaluated in morbidly obese patients undergoing laparoscopic bariatric surgery.
Methods
We studied 100 patients with body mass index >35 kg/m
2
. They were randomly allocated to study (USG-TAP) and control groups. Pain scores at rest and on movement at various time points up to 24 postoperative hours were compared. Other parameters evaluated were patients requiring Tramazac hydrochloride (TMZ) as rescue analgesic, sedation score, time to ambulate, any adverse events, and patient satisfaction.
Results
The median visual analogue scale pain score of the study (USG-TAP) group was consistently lower at 1, 3, 6, 12, and 24 h at rest and on movement, in the postoperative period. Number of patients requiring TMZ required in the first, third, and sixth hour was significantly lower in the USG-TAP group. The prolonged sedative effect of the TMZ affected the time to ambulate. Patients in the control group remained more sedated. Four patients in the control group required BIPAP support postoperatively; no adverse event was observed. Time to ambulate was 6.3 ± 1.8 h in USG-TAP and 8 ± 1.8 h in control groups;
P
< 0.001. Patient satisfaction scores were significantly higher in the USG-TAP group;
P
< 0.001.
Conclusions
Our study demonstrates that the USG-TAP as part of multimodal analgesic technique in morbidly obese patients undergoing laparoscopic gastric bypass reduces opioid requirement, improves pain score, decreases sedation, promotes early ambulation, and has greater patient satisfaction.
Journal Article
Laparoscopic Adjustable Gastric Banding: a Prospective Randomized Clinical Trial Comparing 5-Year Results of two Different Bands in 103 Patients
by
Brimas, Gintautas
,
Juodeikis, Žygimantas
,
Abalikšta, Tomas
in
Adult
,
Bariatric Surgery
,
Body Mass Index
2017
Background
Various types of adjustable gastric bands are used during LAGB, but there is insufficient data comparing different bands in the long term. We carried out a prospective randomized study to compare two different bands.
Methods
Between January 1, 2009 and January 31, 2010, 103 morbidly obese patients were randomized between SAGB and MiniMizer Extra adjustable gastric bands. The SAGB was used in 49 and MiniMizer Extra in 54 patients. Weight loss, comorbidities, long-term complications, and quality of life were evaluated after 5 years.
Results
Patient baseline characteristics were similar in the two groups. The mean patient age was 45.9 ± 11.7 years, and mean preoperative BMI was 47.5 ± 7.3 kg/m
2
. A total of 90 of 103 patients (87.3 %) completed the 5-year follow-up. The mean excess weight loss was 44.1 and 50.3 % in SAGB and MiniMizer groups, respectively (
p
= 0.14). A proportion of patients who reached a BMI < 35 kg/m
2
was significantly larger in MiniMizer Extra group (52.9 vs 25.5 %;
p
= 0.01). Complications developed in 15 patients (14.5 %) and consisted of 5 band erosions, 4 port-related complications, 3 band slippages, and 3 band intolerances. All five band erosions developed in MiniMizer Extra group, but the difference was not significant (
p
= 0.058). No difference was found regarding postoperative complications, resolution of comorbidities, and quality of life between compared groups.
Conclusions
SAGB and MiniMizer Extra bands demonstrated similar long-term results regarding the weight loss, resolution of comorbidities, morbidity, and quality of life.
Journal Article
Effects of Adjustable Gastric Bands on Gastric Emptying, Supra- and Infraband Transit and Satiety: A Randomized Double-Blind Crossover Trial Using a New Technique of Band Visualization
by
Yap, Kenneth
,
Burton, Paul Robert
,
Brown, Wendy A.
in
Adult
,
Clinical outcomes
,
Clinical trials
2010
Background
The laparoscopic adjustable gastric band (LAGB) has previously been classified as a restrictive procedure; physically limiting meal size. Recently, the key mechanism has been hypothesized to be the induction of satiety without restriction. Effects can be controlled by modifying LAGB volume, possibly as a result of effects on gastric emptying or transit through the LAGB.
Methods
Successful LAGB patients underwent paired, double blinded, esophageal transit and gastric emptying scintigraphic studies; with the LAGB at optimal volume and near empty. A new technique allowed assessment of emptying and transit through the infra- and supraband compartments.
Results
Fourteen of 17 patients completed both scans (six males; mean age, 48.9 ± 11.3 years, % excess weight loss 69.0 ± 15.2). At optimal volume a delay in transit of semi-solids into the infraband compartment was observed in ten patients vs. three when the LAGB was empty, (
p
=
0
.
01
). The median retention of a meal in the supraband compartment immediately after cessation of intake was: empty 2.8% (2.3–7.9) vs. optimal 3.6% (1.7–4.5), (
p
=
0
.
57
). Overall gastric emptying half time (minutes) was normal at both volumes: optimal 64.2 ± 29.8 vs. empty 95.2 ± 64.1, (
p
=
0
.
14
). LAGB volume did not affect satiety before the scan: optimal 4.3 ± 1.9 vs. empty 4.0 ± 2.2, (
p
=
0
.
49
), or 90 min later: optimal 6.1 ± 1.9 vs. empty 5.9 ± 1.4, (
p
=
0
.
68
).
Conclusions
The optimally adjusted LAGB briefly delays semi-solid transit into the infraband stomach without physically restricting meal size. The supraband compartment is usually empty of an ingested meal 1–2 min after intake ceases and overall gastric emptying is not affected.
Journal Article
Erosive Esophagitis after Bariatric Surgery: Banded Vertical Gastrectomy versus Banded Roux-en-Y Gastric Bypass
by
de Siqueira Neto, João
,
Azevedo, João Luiz Moreira Coutinho
,
Miguel, Gustavo Peixoto Soares
in
Adult
,
Bariatric Surgery
,
Clinical Research
2011
Background
Obesity is associated with gastroesophageal reflux disease. Roux-en-Y gastric bypass is the most performed bariatric procedure in the world, whereas sleeve gastrectomy is an emerging procedure. Both can be combined with the use of a Silastic® ring. The aim of this study was to compare the evolution of erosive esophagitis (EE) in patients who underwent Silastic® ring gastric bypass (SRGB) and Silastic® ring sleeve gastrectomy (SRSG) after a 1-year postoperative period.
Methods
We carried out a non-randomized, prospective, controlled clinical study. Sixty-five patients were enrolled based on the following inclusion criteria: female gender, age 20–60 years old, BMI 40–45 and written informed consent. The exclusion criteria were secondary obesity, alcohol or drug use, severe psychiatric disorder, binge-eating of sweets, and previous stomach or bowel surgery. The patients were divided into two groups—33 (51%) underwent SRSG and 32 (49%) patients underwent SRGB. All patients underwent an esophago-gastro-duodenoscopy during the preoperative period and at 12–14 months after the surgery.
Results
Preoperatively, 15 patients (23.8%) were found to have EE, six (19.4%) in the SRSG group and nine patients (28.1%) in the SRGB group (
p
= 0.7795). Postoperatively, there was an increase in the number of patients with EE in the SRSG group to 14 (45.2%) and a decrease in the SRGB group to two (6.3%), giving a total of 16 patients with EE (25.4%;
p
= 0.0007).
Conclusions
After 1 year of follow-up, we observed a worsening evolution of EE in the SRSG group, but improvement in the SRGB group.
Journal Article
Laparoscopic Vertical Clip Gastroplasty with BariClip Experience, Complications, Literature Review, and Proposal of Modification of the Original Technique
by
Treviño, Daniel Islas
,
Navarrete, Elkin Benítez
,
Garza, Manuel García
in
Endoscopy
,
Gastroesophageal reflux
,
Gastroesophageal Reflux - etiology
2025
Laparoscopic vertical clip gastroplasty (LVCG) with BariClip is a recent procedure that appears to be safe Gentileschi et al. (Obes Surg 33(1):303-12,
2023
). The initial complications reported include erosion, slippage, and gastroesophageal reflux. This study aimed to report on the experience of a single surgical group, analyzing three clinical cases, conducting a literature review, and proposing a standardization of the technique. A retrospective study was conducted with data from June 2021 to October 2024. We collected the data from the procedures related to the bariatric clip made by only one surgical group; we collected 69 cases with 1 complication of this surgical group. Additionally, we described 2 clinical cases of complications related to bariatric clips from other surgical institutions and reviewed the literature related to the BariClip experience. The results are related to the evaluation of the technique and compare the different modifications implemented over the last 3 years of follow-up. Furthermore, we aim to share our experience in attending to one of the most concerning complications associated with this procedure. The LVCG is a safe procedure with a low incidence of complications and positive results in %EWL. We propose several modifications to the original technique to further reduce complications, and we share the experience of both treating and resolving some of the complications we encountered.
Journal Article
Lap-Band Impact on the Function of the Esophagus
by
Fielding, George A.
,
Traube, Morris
,
Gamagaris, Zoi
in
Effects
,
Esophageal pH Monitoring
,
Esophageal Sphincter, Lower - physiopathology
2008
Background
The laparoscopic adjustable gastric band (LAGB) has been widely used to treat morbid obesity. There is conflicting data on its long-term effect on esophageal function. Our aim was to assess the long-term impact of the LAGB on esophageal motility and pH-metry in patients who had LAGB who had normal and abnormal esophageal function at baseline.
Methods
Consecutive patients referred for bariatric surgery were prospectively enrolled. A detailed medical history was obtained, and esophageal manometric and 24-h pH evaluations were performed in standard fashion preoperatively and 6 and 12 months postoperatively; patients served as their own controls.
Results
Twenty-two patients completed manometric evaluation. Ten patients had normal manometric parameters at baseline; at 6 months, mean lower esophageal sphincter (LES) residual pressure increased significantly from baseline (3.9 ± 2 vs. 8.9 ± 4 mmHg,
p
= 0.014). At 12 months, the mean peristaltic wave duration increased from 3.6 ± 1 at baseline to 6.8 ± 2 s,
p
= 0.025 and wave amplitude decreased during the same period (98.7 ± 22 vs. 52.3 ± 24,
p
= 0.013). LES pressure and percent peristalsis did not differ significantly pre- and post-LAGB. Twelve patients had one or more abnormal manometric findings at baseline; at 12 months, LES pressure in these 12 patients decreased significantly (31.1 ± 10 vs 23.6 ± 7,
p
= 0.011) and wave amplitude was significantly reduced (125.9 ± 117 vs 103 ± 107,
p
= 0.039). LES residual pressure did not change significantly pre- and post-LAGB. Twenty-two individuals were evaluated for impact of Lap-Band on esophageal acid exposure. Sixteen of these patients had normal esophageal pH-metry values at baseline and had no significant changes in 12 months in any pH-metry measurement. Six patients had abnormal pH-metry values at baseline. Among these patients, time with pH < 4.0 and Johnson/DeMeester score did not change significantly during follow-up. There was a significant decrease in the number of reflux episodes from baseline to 6 months (159 ± 48 vs. 81 ± 61,
p
= 0.016).
Conclusions
Abnormal manometric findings are frequently encountered post-LAGB. Increases in LES residual pressure and peristaltic wave duration were the most significant changes. LAGB is not associated with an increase in total esophageal acidification time. Further evaluation of the clinical significance of manometric abnormalities is warranted.
Journal Article
Endoscopic Sleeve Gastroplasty: How I Do It?
by
Fernandez-Corbelle, J. P.
,
Bautista-Castaño, I.
,
Lopez-Nava, G.
in
Adult
,
Body Mass Index
,
Female
2015
Background
Primary endoscopic weight loss therapies are of interest for access, simplicity, and economy. The objective of this manuscript is to describe the endoscopic sleeve gastroplasty used in 50 patients.
Methods
The goal of this procedure is to reduce the gastric lumen into a tubular configuration, with the greater curvature modified by a line of sutured plications. General anesthesia with endotracheal intubation is needed. An endoscopic suturing system requiring a specific double-channel endoscope delivers full-thickness sets of running sutures from the antrum to the fundus. Patients are admitted and observed, with discharge planned within 24 h. Post-procedure outpatient care includes diet instruction with intensive follow-up by a multidisciplinary team. Voluntary oral contrast and endoscopy studies are scheduled to assess the gastroplasty at 3, 6, and 12 months.
Results
The technique was applied in 50 patients (13 men) with an average body mass index (BMI) of 37.7 kg/m
2
(range 30–47) with 13 having reached 1 year. Procedure duration averaged 66 min during which six to eight sutures on average were placed. All patients were discharged in less than 24 h. There were no major intra-procedural, early, or delayed adverse events. Weight loss parameters were satisfactory, mean BMI changes from 37.7 ± 4.6 to 30.9 ± 5.1 kg/m
2
at 1 year, and mean %TBWL was 19.0 ± 10.8. Oral contrast studies and endoscopy revealed sleeve gastroplasty configuration at least until 1 year of follow-up.
Conclusion
Endoscopic sleeve gastroplasty is a safe, effective, and reproducible primary weight loss technique.
Journal Article
Incidence of Regurgitation after the Banded Gastric Bypass
by
Del Grande, José Carlos
,
Yanagita, Edison Takehiko
,
Alves, Ana Karina Soares
in
Adult
,
Chronic Disease
,
Equipment Design
2005
Frequent regurgitation is a common complication following Roux-en-Y gastric bypass (RYGBP). This study investigated the risk of becoming a chronic regurgitator, by considering silicone ring size and lower esophageal sphincter (LES) function, and their relationship with weight loss.
80 morbidly obese patients were randomly selected to undergo surgery using ring length of 62 mm (40 patients, group A) or 77 mm (40 patients, group B), with 6 months' postoperative follow-up. Preoperative esophageal manometry parameters were correlated with occurrence of chronic postoperative regurgitation. Patients were considered to present chronic regurgitation when this occurred on >10 days/month.
The groups were homogeneous regarding age, gender, race, weight, BMI (47.8+/-6.1 vs 50.2+/-6.4 kg/m2) and obesity-related diseases. There were 15% more chronic regurgitators in group A than in group B. Chronic regurgitators in group A lost more weight than chronic regurgitators in group B (P=0.026) or non-chronic regurgitators in group A (P=0.016). A greater proportion of chronic regurgitators had LES hypotonia (mean respiratory pressure <14 mmHg) than did non-chronic regurgitators (P=0.008). Logistic regression demonstrated that the chance of being a chronic regurgitator in group A was 4.5 times greater than in group B (P=0.046), and that the chance of a chronic regurgitator having LES hypotonia was seven times greater than of having normal LES pressure (P=0.006).
Silicone ring size and LES hypotonia are independent prognostic factors for chronic regurgitation following RYGBP. Ring size and chronic regurgitation contribute significantly towards weight loss during the first 6 postoperative months.
Journal Article