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Banded bariatric procedures

Examining the outcomes from primary and revision banded procedures

“Banded bypass maybe more effective in maintaining weight loss but to prove safety and superiority, long term studies are needed

At the recent XXV IFSO World Congress, a series of presentations highlighted the benefits of banded gastric bypass and banded sleeve gastrectomy primary procedures and revisional gastric bypass in helping to prevent weight regain. The banded bariatric surgery session, ‘The value of banding the bypass and the sleeve in the era of metabolic surgery’, looked at the evidence provided by several randomised controlled trials (RCTs) by investigators from Germany, the Netherlands and Belgium. The session was introduced by MAL Fobi who outlined the principles of banding in bariatric and metabolic surgery.

Dr Jodok Fink (University of Freiburg, Center for Bariatric and Metabolic Surgery, Freiburg, Germany) presented the three-year outcomes from a single-centre, prospective RCT that compared banded versus non-banded sleeve gastrectomy and included 94 patients (47 in each group), with the primary endpoint of excess BMI loss 36 months after surgery.

Jodok Fink

There were no significant differences in patient characteristics between the groups, although there were more women, diabetics and patients with reflux oesophagitis in the banded group, and patients in this group also had a higher average BMI.

The outcomes at three years revealed that patients in the banded group reported greater weight loss and BMI reduction, compared with the non-banded group, as well as greater diabetes remission (91% vs 67%). There was one major early complication (portal vein thrombosis) in the non-banded group and three major late complications: two in the banded group (slippage and gastroesophageal reflux requiring conversion to RYGB) and one in the non-banded group (gastroesophageal reflux requiring conversion to RYGB).

Interestingly, Fink noted that reflux was not worse in the banded group, yet this group experienced more regurgitation. When his group compared these outcomes with patients from a retrospective series (Fink et al. Banded versus non-banded sleeve gastrectomy: 5-year results of a matched-pair analysis. SOARD 2019), they found that patients who reported higher rates of regurgitation had ring placement of 6.5cm in circumference, compared to patients with rings of with 7.5cm in circumference.

“Banded sleeve gastrectomy shows clinically significantly better weight loss three years after surgery,” Fink concluded. “However, one possible morbidity after banded sleeve gastrectomy is regurgitation, which could be dependent on ring size ie. 6.5cm vs 7.5cm.”

Banded bypass

Next, Dr Luc Lemmens (AZ Rivierenland, Bornem and Hôpital Delta, Bruxelles, Belgium) presented the outcomes from his series of 1,233 gastric bypass procedures, of which he had 386 patients (banded patients n=158) who has a minimum of five years follow-up and 377 patients (banded patients n=162) who had a minimum of eight years follow-up.

Luc Lemmens

The banded patients had a higher mean pre-operative weight and BMI compared to the non-banded patients and at five years the banded patients showed a higher mean excess weight loss (55.0±15.4kg vs 59.3±12.4kg) and a higher mean percentage excess weight loss (93.3±21.5 vs 101.9±22.2 ~8.8%). At eight years, the banded patients reported a mean 3.1 BMI points lower (or 6% BMI loss) than the non-banded patients.

Regarding weight regain at five years, some 45% of banded patients presented with no weight regain compared to approximately 26% of non-banded patients, and there was a clear trend in weight regain in terms of BMI points for the non-banded patients. In this series, there were no reported early band complications and no instances of band erosion (late complications).

Lemmens added that from approximately 1,200 banded bypass procedures he has had two band migrations (0.17%) and three slippages (0.25%).

BANDOLERA trial

Following Lemmens, Dr Frits Berends (The Netherlands) outlined the potential benefits of the MiniMizer Ring such as better weight loss, less weight regain, less dumping and improvements in GERD symptoms.

“With approximately 20% bariatric surgeries ending in ‘failure’ (weight regain) it is perhaps a mystery why just 1% of the annual 700,000 of bariatric procedures incorporate a ring/band, and conferring the benefits and overall costs of surgery a ring/band does not add a significant cost,” he added. “However, for all the claims about Rings, currently we only have mostly low-grade evidence, with only three RCTs3 reporting data on 400+ patients with 2/3 year follow-up.”

Frits Berends

With this lack of data in mind, in 2015 Berends and colleagues established the BANDOLERA trial, which recruited 130 patients (65 in each group) who will undergo primary either banded or non-banded bypass. The primary endpoint of the trial is total percentage body weight loss after three years and the secondary endpoints are: percentage weight regain after three years, reduction of comorbidities, improvements in the quality of life, dumping complaints and band related complications.

The BANDOLERA trial is utilising the MiniMizer Ring (Bariatric Solutions) that has been specially designed to prevent dilatation and is very easy to place and close, aided by a blunt, silicone covered introduction needle that simplifies retrogastric placement. Berends stressed that the Ring is very different from an adjustable gastric band – the former is fixed with a loose fit, the latter is adjustable with a tight fit.

“Although the results from the BANDOLERA trial cannot be fully revealed as they are currently under review for publication in the literature,” Berends explained. “The take home message is that placing a Ring in RYGB leads to a significant difference in percentage total body weight loss after three years, less weight regain with low rates of Ring related problems.”

Revisional banded-RYGB

Finally, Professor Eric Hazebroek (Rijnstate, the Netherlands) discussed the potential of placing a Ring in revisional RYGB surgery and he began by stating that 20-30% of patients fail to achieve sufficient weight loss or regain weight after initial good weight loss, and a small number of patients need revisional surgery to re-improve results.

Eric Hazebroek

“The BANDOLERA trial may provide insights for primary, but what about revisional procedures? In the literature there is no consensus on if, when or which procedure to use,” he added. “Banded bypass maybe more effective in maintaining weight loss but to prove safety and superiority, long term studies are needed.”

Hazebroek and colleagues will soon report two-year outcomes from a multi-centre cohort study that included 79 patients who were poor responders, defined as TBWL <25% after primary RYGB. Although the unpublished data are currently under review, he noted that redo banded gastric bypass using the MiniMizer Ring has a low major complication rate, requires no anatomical modifications and has a short learning curve (do not make the ring too tight to prevent dysphagia). He concluded that the procedure has a modest effect, when compared to a primary procedure so it is important to manage patient’s expectations. Also, further studies are required to assess the long-term outcomes.

Dr Phil Schauer concluded the session by outlining the current role for banding the bypass in bariatric and metabolic surgery.

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