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
Last updated: 04/04/2013
NCT ID: NCT01489436