Loop Duodenal Switch Surgery in Morbidly Obese Patients

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.

Surgical Procedures:

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.

Inclusion Criteria:

1. The subject must be 18-70 years of age at time of enrollment.

2. The subject must be willing and able to participate in the study procedures and to
understand and sign the informed consent.

3. The subject is under consideration for surgery for obesity or metabolic disease and
elects to undergo a primary loop duodenal switch procedure or as a conversion
procedure for failed, sustained weight loss after a sleeve gastrectomy or
laparoscopic adjustable gastric band performed more than 12 months prior to time of
evaluation.

4. The subject has a BMI of greater than or equal to 40 kg/m2 at time of surgical
consultation.

Exclusion Criteria:

1. Subjects under 18 years of age or older than 70 years of age.

2. Subject is not willing or able to participate in the study procedures and understand
the informed consent.

3. The subject wishes to under a different bariatric procedure other than the loop
duodenal switch.

4. The subject has a BMI of less than 40 kg/m2 at the time of surgical consultation.

5. Any female subject who is pregnant, or is actively breast-feeding

6. Any subject who is considered to be part of a vulnerable population (eg. prisoners or
those with psychological concerns or those without sufficient mental capacity)

7. The procedure is an emergency procedure

8. The subject is unable to unwilling to comply with the study requirements or follow-up
schedule.

9. The subject has comorbidities which, in the opinion of the investigator, will not be
appropriate for the study (eg. severe cardiovascular disease or history of
gastrointestinal malignancy, history of upper GI gastric surgery, history of
intestinal surgery, open cholecystectomy, immunosuppression, and non-ambulatory).

10. The subject has an estimated life expectancy of less than 6 months.

11. The subject has participated in an investigational drug or device research study
within 30 days of enrollment.

12. The subject's insurance company does not cover a duodenal switch operation as
treatment for morbid obesity.