Loop Duodenal Switch Surgery in Morbidly Obese Patients
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|ClinicalTrials.gov Identifier: NCT02671331|
Recruitment Status : Terminated (Principal investigator terminated study due to low enrollment.)
First Posted : February 2, 2016
Last Update Posted : July 7, 2016
|Condition or disease||Intervention/treatment|
|Obesity Type-2 Diabetes Mellitus||Procedure: Loop duodenal switch|
Screening and Informed Consent
Subjects will be screened on a weekly basis for eligibility of enrollment. If eligible, patients will be approached by study staff at the initial surgical consultation. The purpose of the study and risks of the procedures will be explained to the subject and the consent process must be documented accordingly in the medical record. Subjects who agree to study participation must sign an IRB-approved informed consent form. Subjects will be informed that their participation in this study is voluntary and they may refuse to participate or discontinue from the study at any time. Subjects will be given the opportunity to ask the investigator questions so that they are adequately informed about the research. A copy of the signed informed consent must be provided to the subject and the informed consent process will be documented in source documents. If new information becomes available that may affect a subject's decision to continue to take part in the study, this information will be discussed with the subject by the investigator.
Failure to meet submission requirements:
Each patient will be required to meet their individual insurance companies requirements for submission of bariatric surgery approval. Subjects who provide study consent but then do not submit for insurance approval or are denied will be considered "discontinued" and will not require additional study follow-up visits. The reason for the discontinuation will be clearly delineated on the applicable case report form. Subjects in who the loop duodenal switch procedure is begun but not completed will be considered "discontinued" once discharged from the hospital and not require any additional study follow-up visits. Reasons for discontinuation will be recorded in the case report form.
Additionally, female patients of child bearing age will undergo a standard of care pregnancy test at the time of the pre-operative surgical testing (2/3 weeks before surgery) and always the morning of surgery by urine HCG.
The operation will be performed per standard of care and as previously described (1-3), with the exception that in this protocol the duodeno-intestinal anastomosis will be performed at approximately 300 cc with moderate stretch from the ileocecal valve, rather than 200 cm or 250 cm, as in previous reports (Cottam et al, 2015). The purpose of this change is to allow greater nutrient absorption since a previous report observed no difference in mean excess weight loss between 200 cm and 250 cm (3). In addition, the sleeve gastrectomy will be performed over a 40 French bougie. The duodeno-intestinal anastomosis will be hand-sewn.
Subjects will be maintained on a low-calorie diet for the first post-operative month, as per standard of care. In addition, multivitamin supplements, calcium, and iron should be prescribed and maintained per standard of care.
|Study Type :||Observational|
|Actual Enrollment :||1 participants|
|Official Title:||The Effect of Loop Duodenal Switch Surgery in Morbidly Obese Patients on Weight Loss at One Year|
|Study Start Date :||January 2016|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||July 2016|
- Procedure: Loop duodenal switch
The loop duodenal switch (L-DS) is a single anastomosis duodeno-intestinal bypass. In this simplified version of a BPD-DS, a sleeve gastrectomy is followed by a single anastomosis of the duodenum to the ileum in a loop fashion. The proposed benefits of this are to reproduce the excellent weight loss seen after a BPD-DS (an accepted and utilized bariatric procedure in the USA) but with the potential for reduced complications. With one anastomoses in the L-DS over two in the BPD-DS there is a theoretical lower probability of leaks, strictures, reduced anesthesia with shorter operative times, and decreased risk of internal hernia.
- Excess weight loss (EWL) [ Time Frame: 12 months post-procedure ]Excess weight loss is a common metric for reporting weight loss after bariatric surgery. The EWL is calculated from an ideal body mass index (BMI) of 25 kg/m^2 and considers weight before surgery and at 12 months post-procedure.
- Loop duodenal switch related adverse events [ Time Frame: 12 months post-procedure ]Surgery related events such as hospital re-admission, re-operation, complications, etc.
- Resolution rate of obesity related co-morbidities [ Time Frame: 12 months post-procedure ]Resolution of obesity related co-morbidities including type 2 diabetes mellitus, hypertension, sleep apnea, hyperlipidemia, and other obesity-associated co-morbidities.
- SF-36 Quality of Life Survey [ Time Frame: 12 months post-procedure ]Quality of life will be measured using the SF-36 Quality of Life Survey.
- Gastro-esophageal Reflux Disease Health Related Quality of Life Survey [ Time Frame: 12 months post-procedure ]GERD related quality of life will be measured using the Gastro-esophageal Reflux Disease Health Related Quality of Life Survey.
- Gastrointestinal Symptoms Rating [ Time Frame: 12 months post-procedure ]Gastrointestinal Symptoms will be measured using the Gastrointestinal Symptoms Rating Scale.
- Protein malnutrition [ Time Frame: 12 months post-procedure ]Protein malnutrition will be assess by albumin level (hypoalbuminemia, <3.5 g/dL) and serum total protein levels (<6.1 g/dL) when oral intake is adequate ( protein intake of 60g +per day).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671331
|United States, Wisconsin|
|Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Tammy Kindel, MD||Medical College of Wisconsin|