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Updates on banded procedure studies and randomised controlled trials

At the recent International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) World Congress in Naples, Italy, bariatric experts from around the world presented the latest updates on banded bypass, sleeve gastrectomy, re-sleeve gastrectomy and pouch resizing with a gastric ring.

Left to right: Jan Greve, Joerg Zehetner, MAL Fobi and Paolo Gentileschi

Sleeve volume between banded and non‐banded sleeve gastrectomy

In the first presentation, a study from Professor Mohamed Hany presented by Bart Torensma (Medical Research Institute, University of Alexandria, Egypt) explained how pouch dilatation of the sleeve may be an important cause of weight recurrence after LSG as loss of restriction allows more food intake. However, using a band or ring (MiniMizer Ring, Bariatric Solutions International) could prevent pouch expansion, resulting in higher weight loss rates compared to non-banded LSG. However, some studies show no significant differences between banded SG (BSG) and LSG; some patients experience more eating problems.

Bart Torensma

Therefore, Hany and colleagues theorized that a radiological assessment of the sleeve could report sleeve dilatation accurately. A volumetric assessment could correlate the dilatation and weight loss after LSG and BSG.


For this retrospective study, Professor Hany et al. measured weight loss in terms of BMI, percentage of total weight loss, and percentage of excess body weight loss at one-, two, three- and four years, as well as weight recurrence (defined as (1) as a 10% regain of the nadir weight at the last follow-up visit, (2)>10 kg above the nadir weight [5] and (3) BMI increase of≥5 kg/m2 above the nadir), sleeve volume and food tolerance. Sleeve volume was assessed in all patients using a Multi-detector Computed Tomography (MDCT) virtual gastroscopy and 3D reconstruction at six months, one- and four years after surgery.


In total, 1,279 (83.7%) LSG patients and 132 (86.8%) BSG patients completed four years of follow-up and were included in the study. The outcomes demonstrated an overall significant increase in the mean %TWL (p<0.002) and mean %EWL (p<0.001) at one-, two, three- and four years after surgery from baseline. The significant interaction between change in mean %TWL and mean %EWL along post-operative follow-up period and type of surgery explained the greater increase in %TWL and %EWL among those who underwent BSG than those who underwent LSG (p<0.043 and 0.047, respectively).


Average gastric sleeve volume was significantly greater (p<0.001) at four years in the LSG group (580.25+12.25ml) vs. the BSG group (157.94+12.54ml). For food tolerance, there were significant improvements in both cohorts throughout follow-up (p<0.001), with significantly less food tolerance in the BSG vs LSG group.


None of the patients from the BSG group needed conversion to another procedure, compared with 13.4% in the LSG group who had conversions to RYGB surgery (for weight regain, GERD, and GERD and weight regain). Patients who received LSG reported weight regain in all three definitions (a - 10.6%, b - 7.0%, and c - 2.4% of LSG cases), whereas 3.1% banded patients reported weight regain in the first definition (a – 3.1%).


“BSG prevents sleeve pouch dilatation and maintains significantly lower sleeve volume than LSG. However, the dilatation could not be correlated to the rate of %EWL,” he concluded. “BSG was associated with a significantly lower incidence of weight recurrence. Moreover, BSG maintained significantly “worse” food tolerance scores than LSG.”


5-year RCT outcomes of banded RYGB

Professor Eric Hazebroek (Rijnstate/Vitalys, Arnhem, the Netherlands) began his presentation by stating that approximately 20-30% of patients fail to achieve sufficient weight loss or regain weight after initial good weight loss and although most of these patients get back on track with additional counselling a small number of patients needs revisional surgery to re-improve results.

Eric Hazebroek

He added that there are several clinical trials that assessed modifications to the bypass procedures including the ELEGANCE trials (primary & revisional gastric bypass), the Extended Pouch trial and BANDOLERA trial. In the revisional Elegance trial, a long biliopancreatic limb (BPL) gastric bypass (150cm) was compared to standard gastric bypass (BPL 75cm) as a revisional procedure after laparoscopic adjustable gastric band. At four years, the mean total weight loss was 23% for the BPL group and 18% in the standard bypass group, respectively (p=0.036).


The Extended Pouch trial assessed whether extending the pouch could improve results by altering food passage through the pouch by evaluating the effect of an extended pouch RYGB (EP-GB, pouch length 10cm) and standard pouch RYGB (S-GB, pouch length 5cm). There were no significant differences in terms of weight loss during the first two years of follow-up. In the third year of follow-up, the S-GB group regained 3 kg, while in the EP-GB group no weight regain was observed. The mean TBWL after 36 months in the EP-GB group was 31% versus 27% in the S-GB group (p=0.023).


The BANDOLERA trial, which recruited 130 patients (65 in each group), compared primary banded (using the MiniMizer Ring, Bariatric Solutions International) or non-banded bypass. At five-years, total body weight loss was 32.9% in the banded group vs 30.3% in the non-banded group (p=NS), and similar rates of improvements and remission for diabetes, hypertension and dyslipidaemia. However, there were 8 ring removals. Both groups reported improvements in quality of life (differences not significant), there were no differences in PPI usage, nutritional status, multivitamin compliance or dumping related complaints. He added that the results from BANDOLERA showed that banded bypass was safe with sufficient long-term weight loss (with a trend for more weight loss after banded bypass, and similar remission of comorbidities and improvements in QoL).


He revealed that the study designs of the ELEGANCE trial, the Extended Pouch trial and BANDOLERA trial have been combined in a new protocol (UPGRADE study). In this multi-centre RCT, a standard gastric pouch is compared to an extended pouch and a banded-extended gastric pouch. The study is performed in three bariatric centres in the Netherlands (Rijnstate, NOK West and St Antonius). Recruitment has now been completed and patients will be followed for five years.


Surgical technique for recurrent weight gain after Roux-en-Y gastric bypass: pouch resizing with gastric ring

Next, Professor Daniel Moritz Felsenreich (Medical University of Vienna, Vienna, Austria) said that the long-term effects of Roux-en-Y Gastric Bypass (RYGB) showed total weight loss of ~25%. However, some patients do experience weight recurrence for a number of reasons including loss of restriction pouch dilation, GJA dilation, jejunal dilation, gastro-gastric fistula, changes in eating behaviour and gut adaption. Surgical reinterventions for weight regain after RYGB should help to re-establish restriction such as pouch resizing (or remodelling), pouch banding (non-adjustable/adjustable), pouch resizing ± band (prevents re-dilation) and transoral interventions, as well as adding malabsorption.

Daniel Felsenreich

Felsenreich said that all patients initially had a good weight loss success at the Medical University of Vienna. Nevertheless, most of the patients in this study about weight regain had the classic (old) RYGB and over 50% had their primary surgery at other bariatric centres. Due to weight regain, they had at least one of these 4 procedures at the Vienna Medical University: pouch resizing, pouch banding (adjustable) or pouch resizing + pouch banding and shortening of the common limb. All patients had dietary counselling before reintervention. The outcomes were as follows:

  • Ten patients had pouch resizing and lost an additional 28.4±10.4kg (BMI loss 9.2±4.4kg/m2). 50% of patients reported dysphagia and 40% reflux.

  • Thirteen patients underwent pouch banding (adjustable) and lost an additional 21.0±11.0kg (BMI loss 7.6 ±4.2kg/m2). 25% of patients reported dysphagia and 18% reflux.

  • Twenty-nine patients underwent pouch resizing and banding (28 non-adjustable, 1 adjustable) and lost an additional 24.0±11.1kg (BMI loss 8.1±4.7kg/m2). 40% of patients reported dysphagia and 24% reflux.

  • Twenty-nine patients underwent shortening of the common limb and lost an additional 26.0±14.8kg (BMI loss 8.9 ±4.9kg/m2). 58% of patients reported diarrhoea/malnutrition, eight patients had a revision procedure for malnutrition (reversal).

Before any weight regain re-operation an 3D-CT-volumetry is done at the Medical University of Vienna in order to examine the volume of the pouch. He added that swallow MRI is also a valid method for the assessment of pouch volume in different phases of the swallowing process and is comparable to 3D-CT.


Felsenreich´s results revealed that pouch banding may cause dysphagia and reflux, and the shortening of the limb‘s length increases the risk of malnutrition and diarrhoea,” he concluded. “Pouch remodelling is safe and efficient in patients with pouch dilatation, and weight loss in pouch resizing +/- banding is comparable to common limb shortening, but without the risk of malnutrition.”


Banded vs. non-banded Sleeve Gastrectomy

In the next presentation, ‘Banded vs. non-banded Sleeve Gastrectomy: a 5 year update on an RCT’, Professor Jodok Fink (Center for Bariatric and Metabolic Surgery, University of Freiburg, Freiburg, Germany) revealed that banded laparoscopic sleeve gastrectomy (BSG) results in better weight loss and no change in surgical complications compared to non-banded laparoscopic sleeve gastrectomy (LSG), according to the five-year follow-up report from a randomised controlled trial.

Jodok Fink

In this single-centre, prospective trial, the researchers compared the two procedures and included 94 patients (47 in each group). There were no significant differences in patient characteristics between the groups, although there were more women and patients with diabetes in the banded group, and patients in this group also had a slightly higher average preoperative BMI. The three-year outcomes from this study were previously published in the Annals of Surgery (Fink et al. Banded versus nonbanded sleeve gastrectomy: A randomized controlled trial with 3 years follow-up. Annals of Surgery 2020 Nov;272(5):690-695).


At five years, five patients in the banded group (using the MiniMizer Ring, Bariatric Solutions International) and seven patients in the non-banded group were lost to follow-up. The excess weight loss in the per protocol population at five years was 63.7% in the BSG group, compared with 54.9% in the LSG group. Both groups demonstrated remission in T2DM (n=7 (63.6%) and n=6 (66.7%), respectively.


Consistently throughout the study, patients in the BSG group reported a higher rate of regurgitation compared with the LSG group. However, patients in the BSG group did report higher frequency of reflux symptoms each and every year, compared with the LSG group. The rate of late surgical complications was similar between the groups. However, a large percentage of patients in both groups experienced Vitamin D (BSG 41%, LSG 47%) and folic acid (BSG 35%, LSG 40%) deficiency. Iron deficiency was more prominent following BSG (27% vs. LSG 7%).


Comparing patient subgroups, it seemed as if the major difference in weight loss found in this follow-up report of the RCT resulted from patients with a BMI > 50 kg/m2.


“Banded sleeve gastrectomy shows better weight loss than non-banded sleeve gastrectomy five years after surgery,” Fink concluded. “However, banded sleeve patients reported more frequent regurgitation.”


Banded versus non-banded re-sleeve gastrectomy

In the final presentation, a study from Professor Mohamed Hany presented by Bart Torensma (Medical Research Institute, University of Alexandria, Egypt) explained the two-year results from a randomized controlled trial that compared banded (using the MiniMizer Ring, Bariatric Solutions International) versus non-banded re-sleeve gastrectomy as a secondary weight loss procedure after the failure of primary sleeve gastrectomy.


Specifically, the primary endpoints were percentage excess body weight loss (%EWL), percentage total weight loss (%TWL), change in BMI, and associated medical problems after the weight loss at one and two years postoperatively. Secondary endpoints were gastric volume measurement and esophagogastroduodenal (EGD) transit gastroscopy one year postoperatively. The sleeve volume was assessed preoperatively and two years after surgery using multi-detector computed tomography (MDCT) virtual gastroscopy and 3D reconstruction. In year two, 25 patients were left in each group; this was the total number of patients analysed.


Hany et al. reported no significant differences in baseline characteristics between the two groups. The two groups achieved similar %EWL and %TWL at six months, one year and two years postoperatively (%EWL 46.9 vs. 43.6, 83.7 vs. 86.3, and 85.7 vs. 83.9, p=>0.151; %TWL 23.9 vs.21.8, 43.1 vs.43.3, 44.2 vs. 42.2, p=>0.342). However, BMI was significantly lower at two years in the BSG group (24.9 vs. 26.9) compared to the LSG group (p=0.045). Overall, the BMI was significantly reduced two years postoperatively in both groups compared to pre-revisional surgery (47.7 to 24.9 in BSG and 46.9 to 26.0kg/m2 in LSG; p=<0.001). In addition, between years one and two in the LSG cohort, 20 patients (80%) had a 2kg increase in weight (0.5–5 kg), compared with only six patients (24.0%) in the BSG cohort.

The placement of the MiniMizer Ring (Bariatric Solutions International) during a laparoscopic sleeve gastrectomy

Food tolerance was significantly lower with BSG, with an average of -1.1 points (p=<0.001) vs. LSG. However, the reduced postoperative stomach volume significantly reduced the food tolerance score in both groups (p=<0.001). Indeed, the new stomach volume was significantly smaller in the BSG vs. LSG group by 34.6mL on average (159.6 vs. 194.2 mL, p=<0.001). Both groups showed a significant reduction in volume after two years (-248.4 mL vs. -215.8 mL, p=<0.001) in the BSG and LSG groups, respectively). Improvements in hypertension, type 2 diabetes, and dyslipidaemia were reported in both groups.


Postoperative complications were not significantly different between BSG and LSG (84.0 vs. 88.0%, p=1.00). One patient (4%, p=0.784) in the BSG group had the Ring removed after two years at the end of the study because of persistent complaints of GERD C and dysphagia and was converted to an RYGB operation. No leaks, abscesses, 30-day post-op interventions, band erosions, or band slippages were reported during the study period.


After one year, during the endoscopic procedure, 28.0% in the BSG group and 24.0% in the LSG group were free from complications. However, 8.0% of the BSG group had constriction at the ringside, and 48.0 vs. 60.0% had asymptomatic GERD A de Novo in the BSG and LSG groups, respectively. Moreover, 4% had GERD B de Novo in the BSG group, compared to 0% in the LSG group. GERD B + hiatal hernia de Novo was present in 8.0% of the BSG and 16.0% of the LSG groups. After two years, no significant differences in nutritional deficiencies (p≥0.110) were found between both groups.


“Laparoscopic re-LSG is feasible and safe with satisfactory outcomes in patients with weight regain after LSG. Both BSG and LSG had comparable significant weight loss and improvement of associated medical problems,” he concluded. “The BSG tends to have a more stable weight loss after two years with a significantly lower BMI, lower stomach volume and less weight regain.”

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