A Comparison of Single Port and Four Port Laparoscopic Gallbladder Removal

NACompletedINTERVENTIONAL
Enrollment

118

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

March 31, 2014

Study Completion Date

March 31, 2014

Conditions
CHOLELITHIASIS
Interventions
PROCEDURE

Single-port 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. This trocar permits simultaneous introduction of multiple instruments, including a 5-mm flexible-tip laparoscope. Standard 5-mm instruments will be used for retraction and dissection. An additional 2-mm grasping device may be introduced in the right upper quadrant for retraction if necessary. 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.

PROCEDURE

Four-port laparoscopic cholecystectomy

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.

Trial Locations (1)

55905

Mayo Clinic in Rochester, Rochester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mayo Clinic

OTHER

NCT01489436 - A Comparison of Single Port and Four Port Laparoscopic Gallbladder Removal | Biotech Hunter | Biotech Hunter