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Comparative Effectiveness of Novel Minimally Invasive Procedures

18 Years
Open (Enrolling)

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Trial Information

Comparative Effectiveness of Novel Minimally Invasive Procedures

To establish a pathway for comparative effectiveness using patient reported outcomes in
minimally invasive surgery, we propose to use a readily available and easily reproducible
model: cholecystectomy. Each year in the United States, approximately 750,000 patients
undergo a cholecystectomy. Patients clearly prefer the laparoscopic approach over the open
procedure to abdominal surgery. Initial survey data suggest that patients may also prefer
even less invasive approaches.

Currently, the standard operative procedure for a patient with symptomatic gallstone disease
is a laparoscopic cholecystectomy performed under general anesthesia with four small
abdominal incisions. Although postoperative pain and cardiopulmonary and wound
complications are much less compared to open cholecystectomy, considerable cost is generated
from lost productivity in days off of work after the surgical procedure related in part to
pain and the physiologic response to the stress of the operative procedure. Anecdotal data
suggest that fewer incisions, especially fewer transabdominal incisions, translate into less
pain, less need for narcotic pain medication and faster recovery, but randomized trial data
are needed. We propose to compare the effectiveness of the novel single-port
cholecystectomy with laparoscopic cholecystectomy, the current standard of care.

Inclusion Criteria

Inclusion criteria for this study are:

1) patients undergoing cholecystectomy in an elective setting for symptomatic gallstone

Exclusion criteria for the study are:

1. Patients <18 years of age

2. Pregnant patients

3. Patients with ASA-class >3

4. Patients undergoing treatment for chronic pain with opiates

5. Patients with biopsy proven gallbladder cancer

6. Patients who cannot provide consent for the study

7. Patients not willing to participate in the study

8. Prisoners/Institutionalized individuals

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Pain Scores on the Visual Analog Scale

Outcome Description:

The investigators will utilize the Patient-Reported Outcomes from the VAS to measure changes from Baseline to day 1 post OP. A 15-mm difference on a 100-mm visual analog scale with a standard deviation of 25 mm at any time point will constitute a clinically relevant difference.

Outcome Time Frame:

Baseline to Post OP day 1

Safety Issue:


Principal Investigator

Juliane Bingener-Casey, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic


United States: Institutional Review Board

Study ID:




Start Date:

July 2011

Completion Date:

August 2013

Related Keywords:

  • gallstone disease
  • cholecystectomy
  • minimally invasive
  • surgical
  • laparoscopic
  • single port
  • cytokine
  • Cholelithiasis
  • Cholecystolithiasis
  • Gallstones



Mayo Clinic in Rochester Rochester, Minnesota  55905