Bariatric Surgery Clinical Trial
Official title:
A Randomized Study of Robotic Versus Laparoscopic Techniques for Revisional Bariatric Surgery
Obesity has become a significant health problem in Canada. When conservative efforts to lose
weight fail, bariatric surgical procedures are often considered. Today, the most common
bariatric procedures in North America are Laparoscopic Roux-en-Y gastric bypass (LRYGB) and
Laparoscopic Sleeve Gastrectomy (LSG).
For many reasons, an initial bariatric procedure may require surgical revision. Some reasons
include weight regain, failed weight loss or other acute and chronic complications not
related to weight loss. In these cases, it may be indicated that a procedure be reversed inor
converted to another type of bariatric procedure. Regardless of the planned intervention,
revisional surgery is always more difficult than the initial procedure mainly due to surgical
scarring and altered anatomy. Though revisional bariatric surgery has been shown to be safe,
our hope is to improve the safety profile by utilizing robotic surgery. Robotic surgery can
facilitate more complex procedures by providing superior imaging and freedom of movement
during the procedure.
The aim of our study is to evaluate prospectively the outcomes of robotic compared to
laparoscopic revisional bariatric surgery in terms of perioperative outcomes such as
complication rates, operative time and readmissions as well as weight loss/comorbidity
resolution (diabetes, hypertension, sleep apnea) where applicable.
Revisional bariatric surgery is becoming increasingly commonplace in surgical practices.
Approximately 10-25% of patients bariatric surgery will require a revisional procedure at
some point after their initial operation. A conversion from one procedure to another can take
place as part of a planned two-step procedure or due to failed weight loss or weight regain
after the initial procedure. Furthermore, patients can require revision due to other acute
and chronic complications such as marginal ulcers, stenosis and nausea/vomiting. Though these
procedures are generally successful in their intended goal, it is been reported that
complication rates are higher after revision surgery the primary bariatric procedures.
Despite this, few studies have explored methods of increasing safety for revisional bariatric
surgery.
Robotic surgery is a tool that could potentially aid in the safety of revisional bariatric
surgery. Specific to bariatric surgery, the major strengths of robotic surgery is in
facilitating more complex surgical steps, such as a hand-sewn gastrojejunostomy, and
providing superior imaging and freedom of movement compared to traditional laparoscopy. While
these advantages may not confer major benefits in primary bariatric surgery, revisional
bariatric surgery often requires hand-sewn anastomoses in anatomical locations made more
difficult by previous surgical scarring and altered anatomy. This may also translate into a
long-term clinical and economic benefit which could offset the costs of robotics.
Despite this potential, there have been relatively few studies that have investigated the use
of robotic assistance during revisional bariatric surgery and almost none with long-term
data. Furthermore, there is a paucity of high-quality research demonstrating any intervention
that increases safety during revisional bariatric surgery, including robotics. Considering
the current and future demand revisional bariatric surgery, there is a large potential role
for any interventions that can increase safety during these operations.
Aim:
The aim of our study is to prospectively evaluate the difference between robotic and
laparoscopic revisional bariatric surgery in major surgical outcomes and metabolic outcomes,
where applicable.
Study Population:
Patients seen in the bariatric clinic and judged to be potential candidates for revisional of
bariatric surgery will be screened as potential candidates for this study.
Inclusion Criteria
Participants must meet all of the following inclusion criteria:
- The subject previously met National Institutes of Health criteria for bariatric
surgery11 and received a bariatric surgical procedure.
- The subject is under consideration to undergo a revisional bariatric procedure after for
failed sustained weight loss, weight regain or other chronic issues requiring revision.
- The subject is able and willing to give written consent
- The subject must be 18-70 years of age
- The subject must be willing and able to participate in the study procedures and to
understand and sign the informed consent
Exclusion criteria
Participants who meet any of the following criteria at the time of the baseline visit are NOT
eligible to be enrolled in this study:
- The subject has a contraindication to general anesthesia
- The revision does not occur within the first 90 days of the initial bariatric procedure
- The subject has any medical condition, which in the judgment of the Investigator and/or
designee makes the subject a poor candidate for the investigational procedure
- The subject is a pregnant or lactating female (Women of child bearing potential must
take a pregnancy test prior to surgery)
- The subject has an history of alcohol abuse (>30 g/day in men or >20 g/day in women)
- Any subject who is considered to be part of a vulnerable population (e.g. prisoners or
those with psychological concerns or those without sufficient mental capacity)
- The subject is unable or unwilling to comply with the study requirements or follow-up
schedule
- The subject has conditions which, in the opinion of the investigator, will not be
appropriate for the study (e.g. severe cardiovascular disease, history of
gastrointestinal (GI) malignancy, history of upper GI surgery, open cholecystectomy,
history of intestinal surgery, immunosuppression, or non-ambulatory)
- The subject has an estimated life expectancy of less than 6 months
Methodology
All patients will have routine pre-operative bariatric clinic assessment. This includes,
among other things, complete medical history and physical exam, endoscopy, abdominal
ultrasound and blood tests. This involves the nurse, surgeon and internal medicine doctor
that will evaluate the patient regarding co-morbidities.
A prospective study will be able to start in January 2019 and will have a single surgeon
performing robotic revisional bariatric surgery at St. Joseph Healthcare. Robotic revisional
bariatric surgery will be performed according to the National Institutes of Health, as well
as the American College of Surgeons (ACS) and the American Society for Metabolic and
Bariatric Surgery (ASMBS) guidelines. This study will include patients over 18 years-old who
have previously undergone bariatric surgery and a require revisional procedure. The
investigators will collect demographic data related to the patient such the age, gender,
weight, height, BMI, comorbidities such as hypertension, sleep apnea, hypertriglyceridemia,
hypercholesterolemia, type 2 diabetic (with or without insulin therapy). The investigators
will assess the operative time, the immediate postoperative complication rate according to
Dindo-Clavien classification, the mean length of hospital stay, the thirty-day readmission
rate, the thirty-day reoperation rate and the long-term reintervention rate. Follow-up of the
patients at 6 months, 1, 3 and 5 years, will be conducted as per usual through the bariatric
clinic where secondary outcomes will be assessed.
The investigators will randomise 60 patients between robotic (30 patients) and laparoscopic
revisional bariatric surgery (30 patients) to evaluate those procedures in terms of
perioperative safety, weight loss and comorbidity resolution.
Consent:
Patients will be approached for consent during their preoperative evaluation visits at the
Bariatric Clinic. Members of the study team will explain the study to the patient, answer
questions and will explain the informed consent form. Once all questions have been answered
to the patient's satisfaction, the patient will be asked to provide written informed consent.
Randomization:
Once consent has been signed, the patient will be assigned to any of the two groups, using a
computer-based randomization on REDCap and the patient will be assigned to the corresponding
study arm.
Screening:
The patients will have all screening done before consent is signed.
Potential risk:
Potential risks of this study are related to surgery. The patient should not have any
increased risk when assigned to the study group robotic vs standard surgical treatment.
Safety:
Safety will be assessed on an ongoing basis by the Principal Investigator. All adverse events
will be evaluated as they occur by the Principal Investigator to determine the study
continuance and to make any modifications to the procedure when necessary.
Assessment of outcomes
Primary Outcomes
Surgical Complications:
These will be defined by the Clavien-Dindo classification and our primary outcome will be
long-term complications higher than grade III:
Grade III: Requiring surgical, endoscopic or radiological intervention Grade III-a:
intervention not under general anesthesia Grade III-b: intervention under general anesthesia
Grade IV: Life-threatening complication (including CNS complications)‡ requiring
IC/ICU-management Grade IV-a: single organ dysfunction (including dialysis) Grade IV-b: multi
organ dysfunction Grade V: Death of a patient
Long-term reintervention rate:
Reinterventions for chronic surgical complications will be assessed through the bariatric
clinic. Only complications related to the procedure, such as therapeutic endoscopy or
reoperation will be counted.
Secondary Outcomes
Hypertension:
The presence and remission of hypertension will be diagnosed by the definitions suggested in
2003 by the seventh report of the Joint National Committee (JNC 7) and are based upon the
average of two or more properly measured readings at each of two or more office visits after
an initial screen:
- Normal blood pressure: systolic <120 mmHg and diastolic <80 mmHg
- Prehypertension: systolic 120 to 139 mmHg or diastolic 80 to 89 mmHg (see
"Prehypertension")
- Hypertension:
- Stage 1: systolic 140 to 159 mmHg or diastolic 90 to 99 mmHg
- Stage 2: systolic ≥160 mmHg or diastolic ≥100 mmHg
Type 2 diabetes:
The presence and remission of type 2 diabetes will be diagnosed according to the American
Diabetes Association's current criteria:
1. A1C ≥6.5 percent, OR
2. FPG ≥126 mg/dL (7.0 mmol/L), OR
3. Two-hour plasma glucose ≥200 mg/dL (11.1 mmol/L) during an OGTT, OR
4. In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random
plasma glucose ≥200 mg/dL (11.1 mmol/L).
Post-surgical evaluation:
All patients will undergo the standard bariatric postoperative evaluation including:
• Appointments with the bariatric team (surgeon, internist, nurse, dietitian, social worker
and psychologist) at 1 week, 1 month, 3 months, 6 months, 9 months, 1 year, and then on a
yearly basis until at least 5 years after date of surgery.
Statistical analysis:
Descriptive statistics (means, medians, standard deviations) will be used to characterize the
patient population where applicable. Chi square was used to analyze dichotomous patient
variables such as adverse events while continuous variables were analysed using T-tests.
Our primary outcome will be any reintervention, readmission or grade 2, 3, 4 or 5
complication over the entire period of the study. Interim analysis will be done at years 1
and 3. Participants will be followed followed for the 5 years postoperatively. This study is
designed to assess a 50% reduction in time to the primary outcome, with p <0.05 and 80% power
(assuming a major complication/reintervention rate of approximately 20% in the literature).
The primary outcome will be evaluated using a hazard ratio and time-to-event analysis.
Kaplan-Meier curves will created for both groups and compared in a univariable manner using
the log rank test. Two Cox models will then created to assess the hazard ratio between the
treatment and control groups. The first will be a univariable model using treatment as the
only variable. A second, multivariable will be created to ascertain the effect of the
treatment after adjustment for important variable.
Our secondary metabolic outcomes will be assessed using a log transformed generalized linear
model with robust confidence intervals for binary and continuous outcomes, where appropriate.
For binary outcomes, this provides the risk ratios for the effect estimate of robotic vs
laparoscopic approaches. Two regression models will be created to assess the differneces
between the treatment and control groups. The first will be a univariable model using
treatment as the only variable. A second, multivariable was created to ascertain the effect
of the treatment after adjustment for important variables that may not have been balanced
during randomization.
Monte Carlo Markov Chain estimation will be used for the regression models with 100,000
iterations after a 5,000 iteration burn-in. All chains were examined for convergence.
Statistical significance was set at p < 0.05. Data were analyzed using Stata (StataCorp
version 12.1; College Station, TX) and MLwiN (Version 2.26; Centre for Multilevel Modelling,
University of Bristol).
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