Comparison of Two Surgical Techniques for Treatment of Type III Obesity (BMI 40-50 kg/m2): Single Anastomosis Duodenoileal Bypass With Sleeve Gastrectomy and Roux-en-Y Gastric Bypass.

Condition(s) studied

Investigational drug(s) / intervention(s)

SADI-S: In the case of SADI-S, the complete dissection of the antrum and the first portion of the duodenum is performed up to the limit of the gastroduodenal artery. The right gastric artery is dissected, clipped, and sectioned at its root. A vertical gastrectomy is created using a 38F Foucher tube with staplers. Next, the duodenum is sectioned with a stapler, and the resection of the greater gastric curvature is completed. Then, from the left side of the patient, 250 cm is measured from the ileocecal valve, where the duodenoileal anastomosis will be performed. This anastomosis is carried out with the surgeon positioned again between the patient's legs. A manual end-to-side anastomosis with two layers of monofilament is performed. Finally, the vertical gastrectomy and the duodenoileal anastomosis are verified using intraoperative endoscopy or a methylene blue and air test. The gastrectomy specimen is removed through the left pararectal trocar incision. A drain will only be placed in cases of s

RY-GBP: In the case of RY-GBP, first, the lesser gastric curvature is dissected between the cardia and the angular incisura, accessing the gastric transcavity. A horizontal gastric transection is performed using the first firing of a stapler. A gastric reservoir is created through successive firings with a 38F Foucher tube stapler. Next, 100 cm of the biliopancreatic limb is measured, where the manual or semi-mechanical gastrojejunostomy will be performed, with an end-to-side anastomosis using a stapler and manual closure of the loop. Then, 150 cm of the alimentary limb is measured, and a side-to-side jejunojejunostomy is created. A section is made between the two anastomoses. The mesenteric opening and the Petersen space are closed with a continuous non-absorbable suture. The anastomosis is verified using intraoperative endoscopy or a methylene blue and air test. A drain will only be placed in cases of special technical difficulty or intraoperative complications.

Study summary

Roux-en-Y gastric bypass (RY-GBP) is one of the surgical techniques most widely used for the treatment of obesity. Long series of operated patients published in the literature have demonstrated its safety and efficacy. It consists on the reduction of the size of the stomach and joining it (anastomosis) with the small bowel to reduce the absorption of calories.

Single anastomosis duodenoileal with sleeve gastrectomy is an increasingly used surgical technique that is a simplification of the duodenal switch. It consists on the reduction of the stomach to a tube (sleeve gastrectomy) and an anastomosis between the duodenum and the small bowel. It has been demonstrated as a effective technique and it is supported by the international scientific societies.

There are no data that indicate a superiority of one technique over the other. The objective of this study is to analyze if there are differences between the two techniques in terms of postoperative weight control and gastroesophageal reflux at short, medium and long term.

Eligibility

Primary outcome measure(s)

• % of patients with Total weight loss at 2 years > 30% — 2 years after intervention
  % of patients with Total weight loss at 2 years \> 30%
• % of patients with Total weight loss at 5 years > 30% — 5 years after intervention
  % of patients with Total weight loss at 5 years \> 30%
• Short term postoperative complications — From intervention to the end of the short term at 30 days after surgery.
  Complications classified as Clavien-Dindo III or IV (requiring reintervention, endoscopic or radioguided interventional treatment, or admission to the ICU).
• Middle to long-term postoperative complications — From 30 days after intervention to the end of the study 5 years after the intervention.
  In the medium to long term, any complication that requires reintervention, endoscopic or radioguided interventional treatment, ICU admission, maintained parenteral or enteral nutrition, or specific parenteral treatment is included. This encompasses complications attributable to bariatric surgery, such as intestinal obstruction, internal hernia, diarrhea, hypoglycemia, dumping syndrome, malnutrition, ulcer, and GERD. Reintervention due to incisional hernia, cholecystectomy, or causes unrelated to bariatric surgery is excluded.

Trial sites (1)

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