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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02978989
Other study ID # SSGB-1
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 29, 2016
Last updated February 20, 2017
Start date December 2016
Est. completion date September 2017

Study information

Verified date February 2017
Source Daejeon St. Mary's hospital
Contact Say-June Kim, M.D.,Ph.D.
Phone +821087737616
Email sayjunekim@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To determine the safety and feasibility of solo laparoscopic cholecystectomy, which is defined as the application of solo surgery to laparoscopic cholecystectomy, by comparing consecutive non-solo procedures conducted by a surgeon in the presence or absence of human assistant(s).


Description:

Laporoscopic cholecystectomy usually requires three surgeons, including an operator, a camera assistant, and other instrument assistant. Recent advancement of technology made it possible to develop the conveniently adjustable holders for camera and other laparoscopic instruments. The application of these instruments enables "solo-surgery" wherein an operation is driven by single surgeon. During surgery, human assistant(s) are helpful because of their instant assistance according to the operation's need. Therefore, the utilization of instruments instead of human assistants would be cumbersome. However, the utilization of instruments would be helpful by enabling operation-driven repositioning of the camera and instrument(s). Currently, no attempt has been made to objectively compare the merits and demerits of these two procedures. Therefore, this study was conducted to determine the safety and feasibility of solo laparoscopic cholecystectomy, which is defined as the application of solo surgery to laparoscopic cholecystectomy, by comparing consecutive non-solo procedures conducted by a surgeon in the presence or absence of human assistant(s).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date September 2017
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender All
Age group 15 Years to 80 Years
Eligibility Inclusion Criteria:

1. The patients planed to undergo elective laparoscopic cholecystectomy

2. Benign gallbladder diseases requiring surgery

3. The patients who are indicated for single-port laparoscopic cholecystectomy.

Exclusion Criteria:

1. the patients with complicated cholecystitis

2. the patients with the gallbladder with a thickness more than 4mm.

3. the patients who are expected to have severe peritoneal adhesion.

4. the patients with malignant gallbladder diseases.

5. the patients whose operation appears to need human assistant(s)

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
nonsolo LC
This patient is scheduled to undergo nonsolo laparoscpic cholecystectomy.
solo LC
This patient is scheduled to undergo solo laparoscpic cholecystectomy.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Daejeon St. Mary's hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Operation time Operation time correlates with surgical difficulity. day 1
Secondary Pain score Daily pain scores are assessed. day 3
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