Solo and Non-solo Approach for Laparoscopic Cholecystectomy

Cholecystectomy, Laparoscopic Clinical Trial

— SOLOGB  

Official title:

A Randomized Controlled Trial Comparing a Solo and Non-solo Approach for Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02978989
• Other study ID #: SSGB-1
• 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
• 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)

Related Conditions & MeSH terms

• Cholecystectomy, Laparoscopic

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