Randomized Trial Comparing Laparoscopic Roux-en-y Gastric Bypass to Micro-laparoscopic Roux-en-y Gastric Bypass

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01183273
Recruitment Status : Completed
First Posted : August 17, 2010
Last Update Posted : August 22, 2014
Ethicon Endo-Surgery
Information provided by (Responsible Party):
Suzanne J. Rose, Danbury Hospital

Brief 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. 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.

  1. Is there a difference in outcome?
  2. Is there a decrease in postoperative pain?
  3. Does it decrease time off from work?
  4. Does micro-laparoscopy increase OR time?
  5. 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)

  1. NSQIP data to assess outcome
  2. Postoperative usage of pain medication while in the hospital
  3. Time off from work
  4. OR time
  5. Direct cost of procedure as it relates to material used

Condition or disease Intervention/treatment Phase
Obesity Procedure: Microlaparoscopic gastric bypass Procedure: Laparoscopic Surgery Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial Comparing Laparoscopic Roux-en-y Gastric Bypass to Micro-laparoscopic Roux-en-y Gastric Bypass
Study Start Date : March 2010
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Arm Intervention/treatment
Active Comparator: Micro-laparoscopic bypass Procedure: Microlaparoscopic gastric bypass
microlaparoscopic gastric bypass will be performed using standard of care procedure.

Active Comparator: Laparoscopic gastric bypass Procedure: Laparoscopic Surgery
laparoscopic gastric bypass will be performed using standard of care procedure.

Primary Outcome Measures :
  1. Safety of micro-laparoscopic versus laparoscopic gastric bypass [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Postoperative pain [ Time Frame: 30 days ]
  2. Time off from work [ Time Frame: 30 days ]
  3. Operating Cost [ Time Frame: The time of surgery is collected following patient discharge approximately 4 to 5 days ]
  4. Time of Surgery [ Time Frame: The time of surgery is collected following patient discharge approximately 4 to 5 days. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01183273

United States, Connecticut
Danbury Hospital
Danbury, Connecticut, United States, 06810
Sponsors and Collaborators
Suzanne J. Rose
Ethicon Endo-Surgery
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

Responsible Party: Suzanne J. Rose, Director, Office of Clinical Trials, Danbury Hospital Identifier: NCT01183273     History of Changes
Other Study ID Numbers: 29043
First Posted: August 17, 2010    Key Record Dates
Last Update Posted: August 22, 2014
Last Verified: August 2014