Safety and Feasibility of Endomina, an Candy Cane Syndrome Endoluminal Suturing Device
Condition: Bariatric Surgery; Complication
Study type: Interventional

Summary: 
      Surgery is currently the only effective treatment for morbid obesity and can be divided into
      restrictive surgeries (Lap Band and Sleeve gastrectomy), malabsorptive surgeries (Biliary
      pancreatic deviation and duodenal switch) or a combination of both (RYGBP).

      This latter technique is the most common and most effective surgical procedure performed
      worldwide and has been processed to be an effective treatment of morbid obesity and its
      complications, achieving excess weight loss of 65 to 80 %; 1-2 years after surgery (1,2).

      Morbidity after RYGB includes the candy cane syndrome or afferent loop syndrome. Candy cane
      Roux syndrome in patients who have undergone RYGB refers to an excessively long blind
      afferent Roux limb at the gastrojejunostomy causing postprandial pain often relieved by
      vomiting. It is believed that the blind afferent limb ("candy cane") acts as an obstructed
      loop when filled with food (often preferentially), and the distention of the loop causes pain
      until the food either spills into the Roux limb or is vomited back out (3).

      Patients have been reported presenting as early as three months and as late as 11 years after
      their initial RYGB, typically with symptoms of postprandial epigastric pain, nausea,
      vomiting, and reflux or food regurgitation (4). The diagnosis is confirmed by upper
      gastrointestinal contrast studies or endoscopy. On upper gastrointestinal series, the
      afferent limb fills before contrast spills into the Roux limb. On upper endoscopy, the
      afferent limb is usually the most direct outlet of the gastrojejunostomy (3).

      The treatment is revision bariatric surgery, most commonly laparoscopic resection of the
      afferent limb, which ranged in length from 3 to 22 cm in one study (mean of 7.6 cm) (3).
      Symptoms resolve after revision surgery in most patients. Surgeons should minimize the length
      of the blind afferent loop left at the time of initial RYGB to prevent candy cane Roux
      syndrome.

      Endomina (Endo Tools Therapeutics, Gosselies, Belgium) is a CE marked device that may be
      attached to an endoscope inside the body and allows remote actuation of the device during a
      peroral intervention. It offers the possibilities of making transoral full thickness tissue
      apposition and may allow performing, via a transoral route, large plications with tight
      serosa to serosa apposition.
    

Detailed description: 
      Surgery is currently the only effective treatment for morbid obesity and can be divided into
      restrictive surgeries (Lap Band and Sleeve gastrectomy), malabsorptive surgeries (Biliary
      pancreatic deviation and duodenal switch) or a combination of both (RYGBP).

      This latter technique is the most common and most effective surgical procedure performed
      worldwide and has been processed to be an effective treatment of morbid obesity and its
      complications, achieving excess weight loss of 65 to 80 %; 1-2 years after surgery (1,2).

      Morbidity after RYGB includes the candy cane syndrome or afferent loop syndrome. Candy cane
      Roux syndrome in patients who have undergone RYGB refers to an excessively long blind
      afferent Roux limb at the gastrojejunostomy causing postprandial pain often relieved by
      vomiting. It is believed that the blind afferent limb ("candy cane") acts as an obstructed
      loop when filled with food (often preferentially), and the distention of the loop causes pain
      until the food either spills into the Roux limb or is vomited back out (3).

      Patients have been reported presenting as early as three months and as late as 11 years after
      their initial RYGB, typically with symptoms of postprandial epigastric pain, nausea,
      vomiting, and reflux or food regurgitation (4). The diagnosis is confirmed by upper
      gastrointestinal contrast studies or endoscopy. On upper gastrointestinal series, the
      afferent limb fills before contrast spills into the Roux limb. On upper endoscopy, the
      afferent limb is usually the most direct outlet of the gastrojejunostomy (3).

      The treatment is revision bariatric surgery, most commonly laparoscopic resection of the
      afferent limb, which ranged in length from 3 to 22 cm in one study (mean of 7.6 cm) (3).
      Symptoms resolve after revision surgery in most patients. Surgeons should minimize the length
      of the blind afferent loop left at the time of initial RYGB to prevent candy cane Roux
      syndrome.

      Endomina (Endo Tools Therapeutics, Gosselies, Belgium) is a CE marked device that may be
      attached to an endoscope inside the body and allows remote actuation of the device during a
      peroral intervention. It offers the possibilities of making transoral full thickness tissue
      apposition and may allow performing, via a transoral route, large plications with tight
      serosa to serosa apposition.
    

Intervention name(s): Endomina
Intervention type(s): Device
Intervention description(s): The jejunum between the two loops is sutered with Endomina and cut 15 days later.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: endoscopy; mini invasive