Solo and Non-solo Approach for Laparoscopic Cholecystectomy

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02978989

Acronym

SOLOGB

Enrollment

150

Registered

2016-12-01

Start date

2016-12-31

Completion date

2017-09-30

Last updated

2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholecystectomy, Laparoscopic

Keywords

Laparoscopic cholecystectomy, Solo surgery, Camera holder, Cholecystitis

Brief 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).

Detailed 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).

Interventions

PROCEDUREnonsolo LC

This patient is scheduled to undergo nonsolo laparoscpic cholecystectomy.

PROCEDUREsolo LC

This patient is scheduled to undergo solo laparoscpic cholecystectomy.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

15 Years to 80 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
Operation time	day 1	Operation time correlates with surgical difficulity.

Secondary

Measure	Time frame	Description
Pain score	day 3	Daily pain scores are assessed.

Contacts

Primary ContactSay-June Kim, M.D.,Ph.D.

sayjunekim@gmail.com+821087737616

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026