Minimally invasive entero-enteral dual-path bypass using self-assembling magnets.

BACKGROUND: A minimally invasive method of entero-enteral bypass may be desirable for treatment of obstruction, obesity, or metabolic syndrome. We have developed a technology based on miniature self-assembling magnets which create large-caliber anastomoses (incisionless anastomosis system or IAS). The aim of this study was to assess (a) procedural characteristics of IAS deployment and (b) long-term integrity and patency of the resulting jejuno-ileal dual-path bypass. METHODS: Endoscopic jejuno-ileal bypass creation using IAS magnets was performed in 8 Yorkshire pigs survived 3 months. PROCEDURE: The jejunal magnet was endoscopically deployed. However, the ileal magnet required surgical delivery given restraints of porcine anatomy. A 5-mm enterotomy was created through which the ileal magnet was inserted using a modified laparoscopic delivery tool. Magnets were manually coupled. Pigs underwent serial endoscopies for anastomosis assessment. Three-month necropsies were performed, followed by pressure testing of anastomoses and histological analysis. RESULTS: Jejuno-ileal bypass creation using self-assembling IAS magnets was successful in all 8 pigs (100 %). Patent, leak-free bypasses formed in all animals by day 10. All IAS magnets were expelled by day 12. Anastomoses were widely patent at 3 months, with mean maximal diameter of 30 mm. At necropsy, adhesions were minimal. Pressure testing confirmed superior integrity of anastomotic tissue. Histology showed full epithelialization across the anastomosis with no evidence of submucosal fibrosis or inflammation. CONCLUSIONS: Entero-enteral bypass using self-assembling IAS magnets is safe and technically feasible in the porcine model. IAS magnets can be rapidly delivered endoscopically or through a modified laparoscopic device. Expulsion of fused magnets avoids retention of prosthetic material. Anastomoses are widely patent and fully re-epithelialized. Three-month pressure testing reveals anastomotic tissue to be as robust as native tissue, while necropsy and histology suggests minimal/absent tissue inflammation. In human anatomy, a fully endoscopic jejuno-ileal bypass using IAS magnets may be feasible.

Effect of the EndoBarrier Gastrointestinal Liner on obesity and type 2 diabetes: a systematic review and meta-analysis.

Compared with bariatric surgery, less invasive and reversible techniques to counteract obesity and type 2 diabetes (T2D) have been developed, including the EndoBarrier Gastrointestinal Liner [duodenal-jejunal bypass sleeve (DJBS)]. We conducted a systematic review and meta-analyses of eligible trials to evaluate the efficacy and safety of the DJBS. Five randomized controlled trials (RCTs; 235 subjects) and 10 observational studies (211 subjects) were included. The risk of bias was evaluated as high in all studies. The mean body mass index ranged from 30 to 49.2 kg/m(2) and 10-100% of the subjects had T2D. Meta-analysis showed that the DJBS was associated with significant mean differences in body weight and excess weight loss of -5.1 kg [95% confidence interval (CI) -7.3, -3.0; four trials; n = 151; I(2) = 37%] and 12.6% (95% CI 9.0, 16.2; four trials; n = 166; I(2) = 24%), respectively, compared with diet modification. The mean differences in glycated haemoglobin (-0.9%; 95% CI -1.8, 0.0) and fasting plasma glucose (-3.7 mM; 95% CI -8.2, 0.8) among subjects with T2D did not reach statistical significance. Adverse events consisted mainly of abdominal pain, nausea and vomiting. No deaths occurred. Future high-quality long-term RCTs are needed to further assess efficacy and safety.

Laparoscopic hand-sewn revisional gastrojejunal plication for weight loss failure after Roux-en-Y gastric bypass.

BACKGROUND: Revisional surgery has become a widely accepted alternative for weight loss failure/regain after bariatric surgery. However, it is associated to higher morbi-mortality and lesser weight loss than primary bariatric procedure. Our aims are to present a novel technique for weight loss treatment after failed laparoscopic Roux-en-Y gastric bypass (LRYGB) and to report its short-term results. METHODS: This is a retrospective analysis of patients submitted to a revisional hand-sewn double-layer gastrojejunal plication (GJP) for treatment of weight loss failure/regain after LRYGB. Analysis of demographics, body mass index (BMI), and percentage of excess weight loss (%EWL) at the 6th month complications, and financial costs involved was included. RESULTS: Four patients were submitted to revisional GJP. Three patients were female and the mean age at revision was 30 ± 9 years (21-44). The median time interval between LRYGB and GJP was 51 months (24-120). The median BMI at the moment of GJP and the 3rd and 6th month was 35.6 kg/m2 (32.0-37.8), 32.2 kg/m2 (29.7-34.1), and 30.7 kg/m2 (28.1-32.1), respectively. The median %EWL at the 3rd and 6th month was 35.4% (13.6-38.9) and 46.2 % (45.1-55.5), respectively, reaching a cumulative (combined surgeries) %EWL of 62.9% (16.5-67.9) and 71.7% (65.1-77.6), respectively. There were no complications or mortality. Financial costs were significantly lower compared to revisional gastrojejunal stapled reduction (US $1400 cheaper). CONCLUSION: Revisional GJP is a feasible, safe, and cost-effective novel procedure for treatment of weight loss failure/regain after LRYGB. Mid- and long-term results are necessary in order to establish its real effectiveness.

The feasibility of delivering a duodenal-jejunal bypass liner (EndoBarrier) endoscopically with patients under conscious sedation.

BACKGROUND: The endoscopically placed duodenal-jejunal bypass liner (DJBL) or EndoBarrier gastrointestinal liner has been designed for the treatment of type 2 diabetes mellitus and simultaneous achievement of weight loss by obese patients. This study was performed to determine the safety, efficacy, and feasibility of delivering the DJBL with the patient under conscious sedation (CS). The primary end points of the study were safety and complications. The secondary end points were delivery time (min), amount of propofol (mg) used, and the total hospital stay (h). METHODS: This prospective study compared placement of the DJBL with the patient under propofol sedation and placement with the patient under general anesthesia (GA). The study included 56 patients, with 28 patients in each group. RESULTS: Both groups were comparable in terms of age, gender, and body mass index. All the devices were placed successfully, and no complications occurred in either group. Comparison of the CS group with the GA group respectively showed a mean total operation time of 29 versus 56 min, a mean propofol use of 170 versus 258 mg, and a mean hospital stay of 11 versus 22 h. CONCLUSION: Delivery of the DJBL to patients under CS is feasible, safe, and efficient in terms of time and cost. Because of possible complications during the procedure, the authors recommend placement of the DJBL with the patient under CS in proximity to the operating room.

Duodenal-jejunal bypass liners: outcomes in glycaemic control and weight loss.

PURPOSE OF REVIEW: Duodenal-jejunal bypass liners (DJBLs) are a novel therapy with potential treating a range of metabolic diseases. This review discusses the weight loss and glycaemic improvements observed following the use of the DJBL. RECENT FINDINGS: We summarize the evidence for the clinical application of DJBL to date. Within this, we outline the evidence available on the mechanisms of the observed effects. SUMMARY: Based on the most recent trials, we cannot fully mimic the clinical or physiological effects of bariatric surgery with this device, but we are getting closer.

The bilio-intestinal bypass.

BACKGROUND: Since 1990 we adopted the bilio-intestinal bypass (BIBP) for all morbid obese patients eligible to a malabsorption procedure. Since 2001 we used laparoscopic technique. MATERIALS AND METHODS: 102 patients; mean age 35.4 (18-54) years; preoperative mean weight Kg 148.3 (105-225); mean preoperative BMI 54.1 kg/m2 (40-66.2); mean follow-up 10 years (1-22). 83 patients underwent open and 19 laparoscopic BIBP. The operation was performed with five lap ports. Section of the jejunum 30 cm from the Treitz and of mesentery was made by linear stapler. The cholecysto-jejunal anastomosis was completed with 45 mm linear stapler. A side-to-side anastomosis between the proximal jejunum and the last 12-18 cm of the ileum was created by firing a 60 mm linear stapler. On the excluded ileum an anti-reflux valve system was hand-sutured. RESULTS: Five years post-operatively mean weight was 89 (62-130) kg, mean BMI was 31 (24-41) kg/m2. Two patients of the 19 laparoscopic patients were converted in open surgery for adhesions post-appendectomy. The main late complications were incisional hernia (19.3%) and abdominal bloating (2.9%). The reversal and conversion rate was 65%. There was no death. CONCLUSION: Our experience showed that five years post-BIBP the weight loss was satisfactory in 90.7% of patients. Using laparoscopic technique it is possible to reduce pain, in-hospital time, respiratory and thromboembolic complications, convalescence and incisional hernia.

Derivación bilioentérica convergente con mecanismo antireflujo: estudio experimental / Biliary-enteric derivation with antirefluz technic: an experimental study

Con el objeto de evitar reflujo en las derivaciones bilio-entéricas y las complicaciones que se derivan de este fenómeno: se puso a prueba una nueva técnica de derivación, denominada convergente con plicatura entero-entérica. Dicho procedimiento se llevó a cabo en un grupo de perros mestizos recién destetados. Los resultados mostraron que la nueva técnica presentó un menor número de complicaciones, comparada con las que se observaron en sujetos con la derivación "habitual en Y de Roux. No obstante, no suprime los efectos iniciales de la contaminación bilio-hepática

[Use of mechanical staplers in surgical therapy of morbid obesity]. / L'uso delle suturatrici meccaniche nella terapia chirurgica della grande obesità.

The Author reports the experience of the III Surgical Department of the University of Milan on stapling devices in bariatric surgery. The use of stapling devices is now almost irreplaceable for some surgical interventions like gastroplasty, jejuno-ileal bypass, and intestinal bypass revision because staplers simplify and shorten operating procedures, also reducing surgical risk.