Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03206736 |
| Other study ID # |
0281-17-FB |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 9, 2018 |
| Est. completion date |
May 7, 2020 |
Study information
| Verified date |
August 2023 |
| Source |
University of Nebraska |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The biliopancreatic diversion and duodenal switch (BPD-DS) is an accepted and published type
of bariatric surgery in the United States. The BPD-DS procedure produces the most weight loss
of any bariatric surgery commonly performed but has the highest risk of malnutrition and
gastrointestinal side effects. The loop duodenal switch (L-DS) is a bariatric surgery which
has been modified from a biliopancreatic diversion and duodenal switch to maintain excellent
weight loss while possibly reducing side effects. The surgical modifications in this
procedure include reducing the number of intestinal reconnections from two to one and
reducing the amount of small intestine which is bypassed. The L-DS operation is considered
experimental by the American Society of Metabolic and Bariatric Surgery as long-term data in
large numbers of patients is not available for weight loss or side effects. The purpose of
this study is to examine weight loss and other outcomes in the L-DS operation up to 1 year
after the procedure.
Study participants will be seen in the clinic at 2 and 6 weeks, and 3, 6, 9, and 12 months
per the bariatric surgery center protocol. As part of these normally scheduled visits, weight
loss and health status will be recorded. Labs will be checked at 3, 6, and 12 months for
nutritional status. A survey to reassess health-related quality of life and gastrointestinal
symptoms will be performed at 3 months, 6 months and 12 months.
Description:
1. 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 L-DS 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. 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 (Sanchez-Pernaute 2013). 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.
Schedule:
Subjects will be evaluated preoperatively, during the procedure, at discharge, and at 2
weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months. Assessments to be conducted/data
collected at each visit are listed below and in the study assessments table.
1. Pre-operative Assessment The following assessments will be performed pre-operatively
prior to the scheduled surgical procedure and the results recorded on the appropriate
subject report form Verification of pre-operative eligibility criteria Subject
demographics (gender, age, race, ethnicity, smoking history) Height, weight, and body
mass index (BMI) Comorbidity assessment (prevalence and duration of type 2 diabetes
mellitus, sleep apnea, hypertension, dyslipidemia/hyperlipidemia, and other clinically
relevant comorbidities as determined by the treating physician), including medications
Fasting labs (glucose, hemoglobin, HbA1C, hematocrit, ferritin, albumin, total protein,
calcium, parathyroid hormone, vitamin A, Vitamin B1, Vitamin B12, Vitamin D2/3, Vitamin
3, Vitamin K, folic acid, insulin, lipid panel, triglycerides, total cholesterol,
high-density lipoprotein (HDL), low-density lipoprotein (LDL), C-peptides, iron, copper,
and zinc) Surgical history Health- related Quality of life, as measured by the SF-36
assessment Gastrointestinal symptom rating scale, as measured by the GSRS form GERD
HR-QL Pre-operative Dietary Restrictions
2. Operative Assessment The following procedures and assessments will be performed on the
day of/during the procedure: Weight and BMI American Society of Anesthesiologists (ASA)
grade operative time (defined as skin to skin time) anesthesia start and stop time
estimated blood loss adverse events surgical technique (eg protocol requires: 40 French
bougie, distal gastrectomy starting 5 cm distal to the pylorus, duodeno-intestinal
anastomosis performed at approximately 300 cm from the ileocecal valve, hand-sewn
anastomosis, and fascia closure for all port sites accommodating trocars greater than 12
mm) surgical conversions to open concomitant procedures performed during the procedure
3. Discharge Assessment
The following procedures and assessments will be performed prior to discharge:
Length of hospital stay Surgical site infection assessment Surgical site infection (SSI)
Adverse events (see below)
4. Post-operative follow-up assessments The following procedures and assessments will be
performed at 2 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months post procedure
(+/- 7 days for 2 and 6 week follow-up, +/- 14 day days for all other months).
Post-operative standard of care:
Compliance with prescribed dietary supplements Weight and BMI EWL Comorbidity assessment
(prevalence and duration of type 2 diabetes mellitus, sleep apnea, hypertension,
dyslipidemia/hyperlipidemia, and other clinically relevant comorbidities as determined
by the treating physician), including medications and relevant lab tests per standard of
care at 3, 6, and 12 months (glucose, hemoglobin, HbA1C, hematocrit, ferritin, albumin,
total protein, calcium, parathyroid hormone, vitamin A, Vitamin B1, Vitamin B12, Vitamin
D2/3, Vitamin 3, Vitamin K, folic acid, insulin, lipid panel, triglycerides, total
cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), C-peptides,
iron, copper, and zinc) Surgical site infection assessment at 1 month only
health-related quality of life (HR-QOL) (SF-36), GERD-HRQL and GSRS questionnaire
expressed as change from baseline at 3, 6 and 12 months only need for endoscopy adverse
events (see below)
5. Adverse Events Adverse events for all bariatric procedures are tracked within our
centers Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program
(MBSAQIP) database. All bariatric centers accredited by the American Society for
Metabolic and Bariatric Surgery (ASMBS) are required to submit all bariatric surgery
data, including experimental procedures like the L-DS, to the MBSAQIP database for
quality review. Our bariatric surgery team has open access to our centers data for
quality review purposes and will compare adverse events for the L-DS to the other
procedures performed by our center. Adverse events are categorized by organ system
(wound, respiratory, urinary tract, CNS, cardiac, or other) as specified by the MBSAQIP.
Any post-operative occurrence within 30 days will be documented if related to the
bariatric procedure. Bariatric related readmission and reoperations are also tracked per
MBSAQIP guidelines. The L-DS would be stopped if a statistically significant increase in
morbidity, mortality, or failed weight loss is found compared to the centers other
commonly performed bariatric procedures.
