A Comparison of Single Port and Four Port Laparoscopic Gallbladder Removal (CENoMIP)
CHOLELITHIASIS
About this trial
This is an interventional treatment trial for CHOLELITHIASIS focused on measuring gallstone disease, cholecystectomy, minimally invasive, surgical, laparoscopic, single port, cytokine
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:
- Patients <18 years of age
- Pregnant patients
- Patients with ASA-class >3
- Patients undergoing treatment for chronic pain with opiates
- Patients with biopsy proven gallbladder cancer
- Patients who cannot provide consent for the study
- Patients not willing to participate in the study
- Prisoners/Institutionalized individuals
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Single port cholecystectomy
Four-port laparoscopic cholecystectomy
In brief, a flexible, multi-sleeve 15-mm trocar designed specifically for single-port cholecystectomy will be inserted at the umbilicus via a 15-mm single incision. An additional 2-mm grasping device may be introduced in the right upper quadrant for retraction if necessary; this device is placed percutaneously without the need for a trocar. A 5-mm laparoscopic clip applier will be introduced through the periumbilical trocar to ligate the cystic artery and the cystic duct. The gallbladder will be removed through the umbilical port, adequate hemostasis is ensured, the umbilical trocar removed, and the single operative site will be closed and sterile dressings applied (four Band-Aids).
The control procedure for the research practicum is a four-trocar laparoscopic cholecystectomy, the current gold-standard operation. This approach utilizes a 10-mm trocar placed at the umbilicus via a 15-mm incision and three separate subcostal 5-mm trocars placed via separate 5-mm incisions. The gallbladder will be removed through the umbilical trocar site. On occasion, this incision needs to be enlarged to accommodate removal of the gallbladder. Trocar sites will be closed and sterile dressings applied (four Band-Aids).