Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT03199352 |
| Other study ID # |
0280-17-FB |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 6, 2018 |
| Est. completion date |
November 12, 2020 |
Study information
| Verified date |
August 2023 |
| Source |
University of Nebraska |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The technique of laparoscopic Roux-en-Y gastric bypass (RYGB) has evolved significantly over
the past few decades to minimize complication risks such as strictures. Three different
anastomotic techniques are currently widely used hand-sewn (HS), linear-stapled (LS) and
circular stapled (CS). Studies are contradictory as to the best technique to avoid
complications. Many studies have focused on the stricture and infection rates of these
procedures, and minimized the examination of ulceration, gastritis, and anastomotic leak. The
purpose of this study is to prospectively examine how the use of linear-stapled and hand-sewn
anastomotic techniques affect complication rates of marginal ulceration, gastritis, leak and
stricture in patients who undergo RYGB. The goal of this study is to compare the long-term
complication rates between hand-sewn robotic RYGB and linear-stapled laparoscopic RYGB.
Eligible patients are men and women age 19-65 who are to undergo RYGB, have a BMI between
35-45, and RYGB is the primary procedure. The main outcomes to be measured are complications
in marginal ulceration, gastritis, leak, and stricture rate at 2 and 6 weeks, and 3, 6, 9,
12, and 24 months postoperatively.
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 whom the robotic RYGB 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 for both the laparoscopic RYGB and the
robotic RYGB. The main difference between the two procedures is that in the robotic
procedure, the intestinal anastomosis will be hand-sewn and in the laparoscopic RYGB, the
anastomosis will be performed using a linear staple. 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 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 EGD at 1 year to assess
stricture, marginal ulceration, and gastritis 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 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 robotic and laparoscopic RYGB 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.
