Clinical trial NCT01489436: A Comparison of Single Port and Four Port Laparoscopic Gallbladder Removal
Official title: Comparative Effectiveness of Novel Minimally Invasive Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CHOLELITHIASIS
Keywords: gallstone disease
cholecystectomy
minimally invasive
surgical
laparoscopic
single port
cytokine
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-12-09
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Scores on the Visual Analog Scale
timeFrame: Baseline to Post Operative day 1
Secondary outcomes:
measure: Quality of Life (QOL)
timeFrame: up to 7 days
measure: Heart Rate Variability (HRV) Data
timeFrame: During surgery from incision to closure
measure: Cytokine levels in blood
timeFrame: Baseline, during surgery form incision to closure, 1 hour post OP and 4 hour post OP
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Juliane Bingener-Casey, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bingener J, Skaran P, McConico A, Novotny P, Wettstein P, Sletten DM, Park M, Low P, Sloan J. A Double-Blinded Randomized Trial to Compare the Effectiveness of Minimally Invasive Procedures Using Patient-Reported Outcomes. J Am Coll Surg. 2015 Jul;221(1):111-21. doi: 10.1016/j.jamcollsurg.2015.02.022. Epub 2015 Mar 3.