Solo and Non-solo Approach for Laparoscopic Cholecystectomy (SOLOGB)

Daejeon St. Mary's hospital

Status: Unknown

Conditions: Cholecystectomy, Laparoscopic

Treatments: Procedure: nonsolo LC; Procedure: solo LC

Study type: Interventional

Funder types: Other

Identifiers

NCT02978989

SSGB-1

Details and patient eligibility

About

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).

Full 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).

Enrollment: 150 estimated patients

Sex: All

Ages: 15 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups, including a placebo group

LC & nonsolo approach

Placebo Comparator group

Description:

The surgical intervention is nonsolo LC.

Treatment:

Procedure: nonsolo LC

LC & solo approach

Active Comparator group

Description:

The surgical intervention is solo LC.

Treatment:

Procedure: solo LC