A Comparison of Single Port and Four Port Laparoscopic Gallbladder Removal



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:3/21/2019
Start Date:July 2011
End Date:March 2014

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Comparative Effectiveness of Novel Minimally Invasive Procedures

New minimally invasive surgical treatments are often outpatient procedures with low
complication rates, promising fast recovery. The traditional physician-reported outcomes such
as complication rates, blood loss, and hospital stay are not useful to guide treatment
recommendations for one or the other minimally invasive procedure. This study aims to apply
patient-reported outcomes developed within the NIH framework for cancer research and chronic
disease treatment to the comparative effectiveness research in minimally invasive procedures
for benign disease.

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 for this study are:

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

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
We found this trial at
1
site
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Rochester, MN
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