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BANDOLERA trial

BANDOLERA to assess banded vs non-banded bypass

Trial is currently recruiting patients for a randomised clinical trial that will assess banded vs non-banded bypass
BANDOLERA trial is aiming to recruit approximately 130 patients (65 in each group)
The primary endpoint of the trial is total percentage body weight loss after three years

Researchers from the Department of Surgery, Rijnstate Hospital, Arnhem, The Netherlands, have revealed that they are currently recruiting patients for a randomised clinical trial that will assess banded vs non-banded bypass to try and ascertain whether a banded bypass does result in less weight regain compared to the non-banded procedure. Bariatric News talked to principal investigator of the trial, Dr Frits Berends about the aims of the study…

Frits Berends

“Our centre is one of the largest in The Netherlands with approximately 1,100 patients undergoing bariatric surgery each year. As we have such large patient numbers, we are able to undertake lots of research on gastric bypass and we have looked at limb length, pouch size and now we are examining the effect of banded bypass on weight regain,” he explained. “It is estimated that approximately 20% of morbidly obese patients will experience some weight regain and for super-obese patients it is even higher, maybe as high as 35%. There have been several papers in the literature that have suggested that the banded bypass can help prevent weight regain in the long-term.”

The BANDOLERA trial is aiming to recruit approximately 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 trial has started to recruit patients and it is estimate that it will take four to six months to complete enrolment.

MiniMizer Ring

In the trial, Berends and colleagues will be 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.

The MiniMizer Ring also provides the surgeon with several benefits, particularly the ease of which the device can be adjusted to the desired diameter. The Ring can be tailored to suit several closing positions from the largest to the smallest ring size: from 8.0 cm length (approx. 26mm internal diameter), to 7.5 cm length (approx. 24mm internal diameter, 7.0 cm length (approx. 22mm internal diameter) and 6.5 cm length (approx. 20mm internal diameter). This feature also allows for re-opening if the ring is either too tight or too loose, enabling the surgeon to focus on the patients’ individual requirements.

“This will be a unique trial. Although there are a couple of randomised clinical trials that have looked at banded vs. non-banded bypass, to my knowledge none have studied patients out to three years and they only involved small patient numbers,” added Berends. “The banded bypass is not a new procedure but I think there are quite a few surgeons who are sceptical about its benefits, maybe the results from this trial will change their minds?”

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