ObesityNCT01183273
Randomized Trial Comparing Laparoscopic Roux-en-y Gastric Bypass to Micro-laparoscopic Roux-en-y Gastric Bypass
A study testing Microlaparoscopic gastric bypass and Laparoscopic Surgery in people with Obesity, run by Suzanne J. Rose at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Microlaparoscopic gastric bypass and Laparoscopic Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
Read the 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
- Conditions
- Obesity
- Being tested
- Microlaparoscopic gastric bypass, Laparoscopic Surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microlaparoscopic gastric bypassProcedure or surgery
microlaparoscopic gastric bypass will be performed using standard of care procedure.
Laparoscopic SurgeryProcedure or surgery
laparoscopic gastric bypass will be performed using standard of care procedure.
| Study group | Role | What they receive |
|---|---|---|
| Micro-laparoscopic bypass | Active comparator | Not described Receives: Procedure: Microlaparoscopic gastric bypass |
| Laparoscopic gastric bypass | Active comparator | Not described Receives: Procedure: Laparoscopic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of micro-laparoscopic versus laparoscopic gastric bypass
Measured: 2 years
Secondary outcomes (4)
Postoperative pain
Measured: 30 days
Time off from work
Measured: 30 days
Operating Cost
Measured: The time of surgery is collected following patient discharge approximately 4 to 5 days
Time of Surgery
Measured: The time of surgery is collected following patient discharge approximately 4 to 5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzanne J. Rose
- Sponsor type
- University, hospital or other
- Collaborators
- Ethicon Endo-Surgery
- Responsible party
- Sponsor-investigator, Suzanne J. Rose, Danbury Hospital
- Investigators
- Pierre Saldinger, M.D., Study chair, Danbury HospitalKeith Saldinger, M.D., Principal investigator, Danbury HospitalSuzanne J House, M.S., Ph.D., Study director, Danbury Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01183273
- Sponsor's protocol ID
- 29043
- Status last verified
- Aug 2014
- First submitted
- 9 Aug 2010
- Last updated
- 22 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial Comparing Laparoscopic Roux-en-y Gastric Bypass to Micro-laparoscopic Roux-en-y Gastric Bypass
- ClinicalTrials.gov ID
- NCT01183273
- Acronym / sponsor ID
- 29043
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Suzanne J. RoseUniversity, hospital or other
- Collaborators
- Ethicon Endo-Surgery
- Study start
- Mar 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 17 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micro-laparoscopic bypass | Active comparator | Procedure: Microlaparoscopic gastric bypass |
| Laparoscopic gastric bypass | Active comparator | Procedure: Laparoscopic Surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microlaparoscopic gastric bypassmicrolaparoscopic gastric bypass will be performed using standard of care procedure. | Procedure or surgery | Micro-laparoscopic bypass |
| Laparoscopic Surgerylaparoscopic gastric bypass will be performed using standard of care procedure. | Procedure or surgery | Laparoscopic gastric bypass |
Primary outcome
Safety of micro-laparoscopic versus laparoscopic gastric bypass
Time frame: 2 years
4 secondary outcomes
Postoperative pain
Time frame: 30 days
Time off from work
Time frame: 30 days
Operating Cost
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Saldinger, M.D. study chair
Danbury Hospital
Keith Saldinger, M.D. principal investigator
Danbury Hospital
Suzanne J House, M.S., Ph.D. study director
Danbury Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microlaparoscopic gastric bypass and Laparoscopic Surgery in people with Obesity, run by Suzanne J. Rose at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of micro-laparoscopic versus laparoscopic gastric bypass (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2014.