Safety and Feasibility of Endomina, an Candy Cane Syndrome Endoluminal Suturing Device — Endomina  

Bariatric Surgery Clinical Trial

Official title: A Prospective Study to Evaluate the Safety and Feasibility of an Endoluminal-suturing Device (Endomina TM) as an Aid for Afferent Loop Syndrome

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Bariatric Surgery
• Complication

• NCT number: NCT03608267
• Study type: Interventional
• Source: Erasme University Hospital
• Status: Completed
• Phase: N/A
• Start date: March 6, 2018
• Completion date: March 3, 2020