UMIN ID: UMIN000005768
Registered date:13/06/2011
Prospective study of laparoscopic adjustable gastric banding with MIDBAND system for morbidly obese patients
Basic Information
| Recruitment status | Complete: follow-up continuing |
|---|---|
| Health condition(s) or Problem(s) studied | Patients for whom gastric banding was indicated will be included in the study. Exhaustive and consecutive inclusions of 20 patients will be carried out at Yotsuya Medical Cube with the MIDBAND implant. |
| Date of first enrollment | 2011/06/01 |
| Target sample size | 20 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Laparoscopic adjustable gastric banding |
Outcome(s)
| Primary Outcome | Change in weight loss (BMI and percentage of excess weight loss) |
|---|---|
| Secondary Outcome | Change in obesity-related comorbidity status, change in quality of life |
Key inclusion & exclusion criteria
| Age minimum | 18years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | (1) Cardiovascular event in the past 6 months. (2) Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease. (3) Cardiac stress test indicating that surgery would not be safe. (4) Pulmonary embolus or thrombophlebitis in the past 6 months. (5) Cancer of any kind unless documented to be disease-free for 5 years. (6) Significant anemia (hemoglobin 1.0 g or more below normal range) or history of coagulopathy. (7) Serum creatinine 2.0 mg/dl or more. (8) History of stomach surgery, bile duct surgery, pancreatic surgery, splenectomy, or colon resection. (9) Gastric or duodenal ulcer in the past 6 months. (10) History of intra-abdominal sepsis. (11) Self-reported HIV-positive status, active tuberculosis, active malaria, chronic hepatitis B or C, cirrhosis, or inflammatory bowel disease. (12) Currently pregnant or nursing, or planning to become pregnant in the next 2 years. (13) History of alcohol or drug dependency in the past 5 years. (14) Active psychosocial or psychiatric problem that is likely to interfere with adherence to the protocol. (15) Presence of any chronic or debilitating disease that would make adherence to the protocol difficult. (16) Exclusions may also be made at the discretion of the attending physician. |
Related Information
| Primary Sponsor | Yotsuya Medical Cube |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | MID(Medical Inovation et Developpement, Dardilly, France) |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | |
| yosuke_seki@hotmail.com | |
| Affiliation | Yotsuya Medical Cube Weight Loss and Metabolic Surgery Center |
| scientific contact | |
| Name | Kazunori Kasama |
| Address | 7-7 Nibancho, Chiyoda-ku, Tokyo Japan |
| Telephone | |
| Affiliation | Yotsuya Medical Cube Weight Loss and Metabolic Surgery Center |