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

NCT01183273 | Completed

• 1 other identifier: 29043
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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. 1.Is there a difference in outcome?
2. 2.Is there a decrease in postoperative pain?
3. 3.Does it decrease time off from work?
4. 4.Does micro-laparoscopy increase OR time?
5. 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.
6. 6.NSQIP data to assess outcome
7. 7.Postoperative usage of pain medication while in the hospital
8. 8.Time off from work
9. 9.OR time
10. 10.Direct cost of procedure as it relates to material used

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Safety of micro-laparoscopic versus laparoscopic gastric bypass

  2 years

Secondary Outcomes (4)

• Postoperative pain

  30 days

• Time off from work

  30 days

• Operating Cost

  The time of surgery is collected following patient discharge approximately 4 to 5 days

• Time of Surgery

  The time of surgery is collected following patient discharge approximately 4 to 5 days.

Study Arms (2)

Micro-laparoscopic bypass

ACTIVE COMPARATOR

Procedure: Microlaparoscopic gastric bypass

Laparoscopic gastric bypass

ACTIVE COMPARATOR

Procedure: Laparoscopic Surgery

Interventions

Microlaparoscopic gastric bypass PROCEDURE

microlaparoscopic gastric bypass will be performed using standard of care procedure.

Micro-laparoscopic bypass

Laparoscopic Surgery PROCEDURE

laparoscopic gastric bypass will be performed using standard of care procedure.

Laparoscopic gastric bypass

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzanne J. Rose: lead
• Ethicon Endo-Surgery: collaborator

Study Sites (1)

Danbury Hospital

Danbury, Connecticut, 06810, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Pierre Saldinger, M.D.

  Danbury Hospital

  STUDY CHAIR

• Keith Saldinger, M.D.

  Danbury Hospital

  PRINCIPAL INVESTIGATOR

• Suzanne J House, M.S., Ph.D.

  Danbury Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Office of Clinical Trials

Study Record Dates

• First Submitted: August 9, 2010
• First Posted: August 17, 2010
• Study Start: March 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 22, 2014

Record last verified: 2014-08

Locations

US (1)