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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Danbury Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ethicon Endo-Surgery
Information provided by:
Danbury Hospital
ClinicalTrials.gov Identifier:
NCT01183273
First received: August 9, 2010
Last updated: June 27, 2011
Last verified: June 2011
  Purpose

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 Intervention
Obesity
Procedure: Microlaparoscopic gastric bypass
Procedure: Laparoscopic Surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial Comparing Laparoscopic Roux-en-y Gastric Bypass to Micro-laparoscopic Roux-en-y Gastric Bypass

Resource links provided by NLM:


Further study details as provided by Danbury Hospital:

Primary Outcome Measures:
  • Safety of micro-laparoscopic versus laparoscopic gastric bypass [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Postoperative pain [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Time off from work [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Operating Cost [ Time Frame: The time of surgery is collected following patient discharge approximately 4 to 5 days ] [ Designated as safety issue: No ]
  • Time of Surgery [ Time Frame: The time of surgery is collected following patient discharge approximately 4 to 5 days. ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: March 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01183273

Locations
United States, Connecticut
Danbury Hospital Recruiting
Danbury, Connecticut, United States, 06810
Contact: Suzanne J House, M.S., Ph.D.    203-739-8074    suzanne.house@danhosp.org   
Sponsors and Collaborators
Danbury Hospital
Ethicon Endo-Surgery
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
  More Information

No publications provided

Responsible Party: Pierre F. Saldinger, M.D./ Chairman, Department of Surgery, Danbury Hospital
ClinicalTrials.gov Identifier: NCT01183273     History of Changes
Other Study ID Numbers: 29043
Study First Received: August 9, 2010
Last Updated: June 27, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014