- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01183273
Randomized Trial Comparing Laparoscopic Roux-en-y Gastric Bypass to Micro-laparoscopic Roux-en-y Gastric Bypass
Prospective Randomized Trial Comparing Laparoscopic Roux-en-y Gastric Bypass to Micro-laparoscopic Roux-en-y Gastric Bypass
Background Laparoscopy is the preferred surgical approach for a number of different diseases as it allows for diagnosis and treatment in the setting of a safe and feasible method offering enhanced cosmesis. The natural evolution of laparoscopy is micro-laparoscopy which utilizes smaller instruments and optics. Technological advancements have enabled miniaturization of the surgical equipment without compromising diagnostic or operative capabilities.
Dr. Keith Zuccala is currently performing micro-laparoscopic gastric bypass with an identical safety profile as traditional laparoscopy (NSQIP data comparison between Dr. Laura Choi and Dr. Keith Zuccala). The current trend in laparoscopy is to minimize incisions and their size to decrease trauma to the abdominal wall.
Study Design Both methods have never been compared in a prospective randomized trial to address the following questions.
- Is there a difference in outcome?
- Is there a decrease in postoperative pain?
- Does it decrease time off from work?
- Does micro-laparoscopy increase OR time?
- What is the effect on cost of micro-laparoscopy? Patients will be randomized to one or the other method, disclosing that to the investigators best knowledge both methods are equally safe and that Dr. Zuccala has performed several hundred cases using both methods.
Patient Population Projected sample size would be 50 patients in each group. Accrual should be feasible over the course of 9-12 months.
Data collection (patients will be followed for a total of 30 days for the purpose of this study)
- NSQIP data to assess outcome
- Postoperative usage of pain medication while in the hospital
- Time off from work
- OR time
- Direct cost of procedure as it relates to material used
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study compares two groups of patients who have voluntarily chosen to undergo roux-n-y gastric bypass surgery. The groups will be randomized to receive micro-laparoscopic or laparoscopic surgery to be performed by the same surgeon, Dr. Keith Zuccala.
Study Schema
- The patient attends an informational seminar conducted by the Bariatric Surgery Department
- The patient is scheduled for an initial consultation with the bariatric PA/NP where the patient provides: a letter of referral for Bariatric Surgery from primary care doctor or specialty physician; insurance referral; and assurance that health insurance coverage includes Bariatric Surgery.
- Following the initial consultation, the patient is scheduled for the following: comprehensive blood testing; psychological screening/evaluation; dietary evaluation; appointment with the surgeon; pulmonary evaluation (if needed); cardiology evaluation (if needed); gastroenterology evaluation (if needed).
- An appointment for medical clearance with the referring surgeon is scheduled and completed within three weeks of surgery. At this appointment an electrocardiogram (EKG) and repeat blood work will be carried out.
- The patient is deemed to meet all inclusion criteria.
- The patient is advised to follow all pre-operative instructions as advised by the nursing staff and explained in the Danbury Hospital Center for Weight Loss Surgery Guide.
- Surgical procedures performed are standard for those already utilized daily in the surgery department for gastric bypass procedures.
- The patient is closely observed in the hospital and given specific discharge instructions upon leaving the hospital
- The patient is followed for a maximum of 60 days after surgery and asked how many days of work they missed.
- The NSQIP data base and patient medical record are used to assess outcome, postoperative pain, OR time and surgery cost
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Connecticut
-
Danbury, Connecticut, United States, 06810
- Danbury Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- A body mass index (BMI) ≥ 40 with or without co-morbid conditions*
- A BMI ≥ 35 with co-morbid conditions*
- Permanent lifestyle changes including exercise
- No significant, untreated psychiatric illnesses
- Age ≥ 18 years
- Sufficient ability and cognition to understand surgery, potential complications and subsequent associated changes
- Willingness to participate in treatment and long-term follow-up
- Proof of failed attempts at non-surgical weight reduction
- Acceptable medical/operative risks * Co-morbid solutions include: hypertension, diabetes mellitus, cardiac disease, hypercholesterolemia/hyperlipidemia, sleep apnea, asthma, hypoventilation syndrome of obesity, degenerative joint disease, gastro-esophageal reflux disease, venous stasis ulcers, depression, menstrual irregularities/infertility, polycystic ovary syndrome, fungal skin infections.
Exclusion Criteria:
- The need to convert from laparoscopic roux-n-y to an open abdominal procedure.
- Patients with congestive heart failure or other serious illness which would prevent the patient from a successful surgery and recovery
- Women who are nursing or pregnant
- Patients who smoke
- Patient's insurance will not cover the cost of surgery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Micro-laparoscopic bypass
|
microlaparoscopic gastric bypass will be performed using standard of care procedure.
|
ACTIVE_COMPARATOR: Laparoscopic gastric bypass
|
laparoscopic gastric bypass will be performed using standard of care procedure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety of micro-laparoscopic versus laparoscopic gastric bypass
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Postoperative pain
Time Frame: 30 days
|
30 days
|
Time off from work
Time Frame: 30 days
|
30 days
|
Operating Cost
Time Frame: The time of surgery is collected following patient discharge approximately 4 to 5 days
|
The time of surgery is collected following patient discharge approximately 4 to 5 days
|
Time of Surgery
Time Frame: The time of surgery is collected following patient discharge approximately 4 to 5 days.
|
The time of surgery is collected following patient discharge approximately 4 to 5 days.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Pierre Saldinger, M.D., Danbury Hospital
- Principal Investigator: Keith Saldinger, M.D., Danbury Hospital
- Study Director: Suzanne J House, M.S., Ph.D., Danbury Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 29043
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on Microlaparoscopic gastric bypass
-
Puerta de Hierro University HospitalActive, not recruitingPostoperative Complications | Weight Loss | Morbid ObesitySpain
-
Medical University of ViennaUnknown
-
Slotervaart HospitalAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)UnknownType 2 Diabetes Mellitus | Obesity, MorbidNetherlands
-
Puerta de Hierro University HospitalEnrolling by invitationPostoperative Complications | Weight Loss | Morbid ObesitySpain
-
Nemocnice Břeclav, p.o.UnknownDiabetes Mellitus, Type 2 | Obesity, SevereCzech Republic
-
Hospital Universitario Virgen de la ArrixacaUnknownObesity | Diabetes MellitusSpain
-
Kaunas University of MedicineUnknown
-
Ain Shams UniversitySuspended
-
Helsinki University Central HospitalActive, not recruiting
-
Spital Limmattal SchlierenRecruitingGERD | Obesity, Morbid | Ulcer, GastricSwitzerland