Trial Description. Organizational Data. DRKS-ID: DRKS Date of Registration in DRKS: 2015/01/30. Title. MiniMizer for Sleeve Optimization

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1 Trial Description Title MiniMizer for Sleeve Optimization Trial Acronym MISO URL of the trial [---]* Brief Summary in Lay Language There are different methods of surgical treatment for obese persons. Sleeve gastrectomy is one of the most common bariatric procedures. In laparoscopic sleeve gastrectomy, the stomach is reduced to a narrow tube which results in a final volume of approximately 100 ml. In average, laparoscopic sleeve gastrectomy allows an excess weight loss of 60 %. However, sleeve dilatation with consecutive weight regain has been observed in some patients. New studies revealed that the implantation of a non-adjustable gastric band may prevent dilatation of the sleeve as a source of treatment failure. The aim of this trial is to investigate, if the additional implantation of a gastric ring improves long-term weight loss after sleeve gastrectomy and prevents dilatation of the gastric sleeve. Brief Summary in Scientific Language There are different methods of surgical treatment for obese persons. Sleeve gastrectomy is one of the most common bariatric procedures. In laparoscopic sleeve gastrectomy, the stomach is reduced to a narrow tube which results in a final volume of approximately 100 ml. In average, laparoscopic sleeve gastrectomy allows an excess weight loss of 60 %. However, sleeve dilatation with consecutive weight regain has been observed in some patients. New studies revealed that the implantation of a non-adjustable gastric band may prevent dilatation of the sleeve as a source of treatment failure. The aim of this trial is to investigate, if the additional implantation of a gastric ring improves long-term weight loss after sleeve gastrectomy and prevents dilatation of the gastric sleeve. Organizational Data DRKS-ID: DRKS Investigator Sponsored/Initiated Trial (IST/IIT): yes Ethics Approval/Approval of the Ethics Committee: Approved (leading) Ethics Committee Nr.: 525/14, Ethik-Kommission der Albert-Ludwigs- Universität Freiburg Page 1 of 5

2 DRKS-ID: DRKS Investigator Sponsored/Initiated Trial (IST/IIT): yes Ethics Approval/Approval of the Ethics Committee: Approved (leading) Ethics Committee Nr.: 525/14, Ethik-Kommission der Albert-Ludwigs- Universität Freiburg Secondary IDs Universal Trial Number (UTN): U Health condition or Problem studied ICD10: E66 - Obesity Interventions/Observational Groups Arm 1: laparoscopic sleeve gastrectomy without MiniMizer Ring Arm 2: laparoscopic sleeve gastrectomy with MiniMizer Ring Characteristics Study Type: Interventional Study Type Non-Interventional: [---]* Allocation: Randomized controlled trial Blinding: [---]* Who is blinded: [---]* Control: Active control (effective treament of control group) Purpose: Treatment Assignment: Parallel Phase: N/A Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): N/A Primary Outcome Page 2 of 5

3 Weight loss after 36 months Secondary Outcome HbA1c, number of antidiabetic drugs, blood pressure, number of antihypertension drugs, triglycerides, LDL, HDL, total cholersterol, occurence of reflux, dysphagia, occurence of adverse events, operation time, hosptal stay, Occurence of postsurgical regurgitation after 1, 3, 6, 12 and 36 months, volume of gastric sleeve after 1 and 3 years (MRI) Countries of recruitment DE Locations of Recruitment Recruitment Planned/Actual: Actual (Anticipated or Actual) Date of First Enrollment: 2015/01/31 Target Sample Size: 94 Monocenter/Multicenter trial: Monocenter trial National/International: National Inclusion Criteria Gender: Both, male and female Minimum Age: 19 Years Maximum Age: 64 Years Additional Inclusion Criteria ->18 and < 65 years, BMI >= 35kg/m2 and existence of obesety-related comorbiditys as there are: type 2 diabetes mellitus, arterial hypertension, sleep apnea, degenerative diseases of the spine or knees, or BMI >=40kg/m2, signed informed consent Exclusion criteria -history of obesity surgery -history of major abdominal surgery with resection of the stomach, small and large bowel (exception: appendectomym cholecystectomy, umbilical hernia repair, Page 3 of 5

4 incisional hernia repair, ingual hernia repair), Patients not eligible to implement silastic ring, history of drug or alcohol abuse, history of major psychiatric illness conflicting with patient s compliance, lack of compliance, autoimmune disease, inflammatory bowel disease or malabsorptive disease, liver cirrhosis (CHILD A, B, C), active viral or bacterial disease, pregnant women or women with childbearing potential without efficient contraception, history of cancer in the last five years, severe gastroesophageal reflux disease with Barrett s dysplasia or hiatal hernia >5cm Addresses Primary Sponsor Contact for Scientific Queries Contact for Public Queries Page 4 of 5

5 Sources of Monetary or Material Support Institutional budget, no external funding (budget of sponsor/pi) Universitätsklinkum Freiburg Abteilung Allgemein- und Viszeralchirurgie Telephone: 0761/ Fax: [---]* [---]* Status Recruitment Status: Recruiting complete, follow-up continuing Study Closing (LPLV): [---]* Trial Publications, Results and other documents * This entry means the parameter is not applicable or has not been set. Page 5 of 5