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Biologic band

Biologic band on gastric micropouch: Is it safe?

Randomised controlled trials needed to assess long term safety and efficacy
Audun Sigurdsson

According to Dr Audun Sigurdsson, Princess Royal Hospital, Telford, UK, preventing weight regain after gastric bypass remains a challenge within bariatric surgery. Weight gain usually starts two years post-operation and failure at five years has been recorded in 9% of morbidly obese patients and 43% of super obese patients. Moreover, the failure at ten years doubles for morbidly obese patients to 20% and rises to 58% for super obese patients, this is in conjunction with the return or of a co-morbidity or the development of a new co-morbidity, and reduced quality of life (QOL).


According to the literature, there are several reasons of weight regain after gastric bypass including: pouch dilatation; GJ anastomotic dilatation; failure to sustain elevated plasma PYY; and psychosocial/maladaptive eating.


Although permanent, synthetic non-adjustable bands (such as the Fobi Band) have been shown in non-randomised trials to reduce weight regain, they are associated with a small, but significant risk of band erosion (2–6%), band revision operations (6%) and food intolerance (4–6%). 


There are several treatments for weight regain including: revisional surgery for the pouch and GJ anastomosis (associated with higher morbidity and mortality); adjustable/non-adjustable bands on bypass; and endoscopic treatment (Stomaphix). 


Biodesign


As a result, Sigurdsson and colleagues decided to investigate the safety and efficiency of the Biodesign Surgisis 4 Layer Tissue Graft (Cook Medical) to reinforce the gastric micropouch for the same purpose. Previously, the research team has implanted approximately 300 implants in past seven years in hiatus hernia repair, repair of leaking anastomosis and oesophageal perforation. 


A total of 15 patients (11 females) underwent laparoscopic Roux-en-Y gastric bypass (LRYGB). There were four conversions from gastric band and patients had an average BMI of 45 (range 33–58). A 15ml gastric pouch was created and a 100cm biliopancreatic limb and 150cm alimentary limb with variable common limb was performed. Linear staplers were used to create the gastrojejunostomy and the entero-enterostomy. The biologic mesh (Biodesign) 10 x 7cm 4ply folded in three layers was used and wrapped around the micro-pouch 1cm above the anastomosis and fixed with absorbable sutures. Patients were followed up for median of six months (1–12) with clinical evaluation and barium swallows to assess for potential side effects.



Results


The outcomes revealed that there was a mean excess body weight loss of 38%. One patient had post-operative pain and vomiting. There were no complications associated with the biologic mesh, no patients had band erosion or food intolerance. 


“It appears that biologic band reinforcement of gastric micro-pouch in LRYGB appears to be safe in the short term,” said Sigurdsson. “Only time will tell if it will reduce the incidence of weight regain. Randomised controlled trials are needed to assess its safety and efficacy long term.”

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